By:Financial
The European Commission has granted Novartis a new indication for Lucentis (ranibizumab) to treat patients with visual impairment due to diabetic macular edema (DME), a leading cause of blindness in the working-age population in most developed countries.
Laser therapy, the current standard of care, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis is the first licensed therapy to significantly improve both vision and vision-related quality of life in patients with visual impairment due to DME.
"Similarly to wet age related macular degeneration, diabetic macular edema can cause disabling vision loss. While vision loss as a consequence of diabetes affects only a very small proportion of people with the disease, it is one of the most feared complications," said Don Curran, Chair, AMD Alliance International. "Visual impairment impacts everything from managing social interactions to the ability to work - thus, for most people it means a loss of independence."
The approval of Lucentis was based on data from two Novartis-sponsored clinical trials, RESTORE and RESOLVE, which showed that Lucentis was superior in providing rapid and sustained visual acuity gain versus sham (dummy) therapy or laser therapy, the current standard of care.
"In the clinical trials, Lucentis-treated patients began to recover their vision as early as eight days after the first injection on average, and vision improvement was maintained at one year," said Gabriele E. Lang, Professor, University Eye Hospital, University of Ulm, Germany. "The vision improvement for many of these patients was clinically significant, meaning that they regained the ability to carry out day-to-day activities such as driving."
The RESTORE study showed patients treated with Lucentis alone or with Lucentis plus laser therapy gained an average of 6.8 letters and 6.4 letters, respectively, in visual acuity at 12 months compared to baseline, while laser-treated patients gained an average of 0.9 letters as measured on a standard ETDRS eye chart.
The RESOLVE study showed that Lucentis-treated patients gained an average of 10.3 letters in visual acuity at 12 months compared to baseline while sham-treated patients, some of whom also received laser treatment, lost an average of 1.4 letters.
"Since its first launch in the EU in 2007, Lucentis has become the gold standard treatment of wet AMD and its use has stimulated research into other ocular conditions," said David Epstein, Division Head of Novartis Pharmaceuticals. "Our continued investment in the clinical development of Lucentis means that another group of patients who are at risk of losing their eyesight will have the option of a licensed therapy that could help save their vision."
"The pivotal data from RESTORE and RESOLVE studies are further supported by results of an independent US study examining Lucentis for the treatment of DME compared to standard of care. Conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), this study showed that at 12 months patients treated with Lucentis plus laser gained an average of nine letters in visual acuity compared to baseline while patients treated with laser therapy alone gained an average of three to four letters. In addition, the study demonstrated superior gains in visual acuity among Lucentis-treated patients up to two years, with a reduced number of Lucentis injections required the second year compared to the first. Specifically, there was a median of only two to three injections required in the second year of treatment compared to a median of eight to nine injections required in the first year," Novartis said.
Diabetic macular edema (DME) is a consequence of diabetic retinopathy, the most common diabetic eye complication. DME is characterized by changes in the blood vessels of the retina, which is the light-sensitive layer at the back of the eye. In patients with DME, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DME can lead to significant visual impairment. Visual impairment due to DME affects approximately 1-3% of patients with diabetes, and DME is a leading cause of blindness in the working-age population in most developed countries.
Lucentis offers an entirely new pharmacological approach to treatment for visual impairment due to DME compared to the current standard of care, which involves the use of laser burns to stop capillary leakage and reduce swelling. Lucentis is an antibody fragment that is injected into the eye and neutralizes vascular endothelial growth factor (VEGF), a protein that is known to increase vascular permeability, resulting in capillary leakage and macular edema in patients with diabetes.
Lucentis was generally well tolerated in DME clinical studies, either when given as monotherapy or when combined with laser treatment. Its safety profile was consistent with the well established profile in patients with wet age-related macular degeneration (wet AMD). There was an incidence of arterial thromboembolic events (<=3.5%) observed in the DME clinical trials, consistent with what was seen in the wet AMD clinical trials, with no significant difference between the groups treated with Lucentis compared to sham or laser therapy. Ocular adverse events were similar to those seen in the wet AMD trials, with an incidence of 1.4% endophthalmitis in the pooled pivotal studies.
Lucentis is currently licensed in more than 85 countries for the treatment of wet AMD. It receives continuous safety monitoring via a systematic pharmacovigilance system and there is more than 750,000 patient-treatment years of exposure to date for Lucentis.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States, where Lucentis is also approved for the treatment of macular edema following retinal vein occlusion (RVO). In addition, Genentech is conducting two Phase III studies, RISE and RIDE, in patients with diabetic macular edema with results expected in 2011. Novartis has exclusive rights in the rest of the world and has filed in the European Union for approval of Lucentis for the treatment of visual impairment due to macular edema secondary to RVO.
Sunday, January 9, 2011
Sunday, January 2, 2011
Macular Degeneration Treatments
by:Akler Eye Center
Macular degeneration, or Age-Related Macular Degeneration (ARMD) is a condition related to aging of the eye that causes loss of the central vision. It is the commonest cause of blindness in Americans over 55 years old. Approximately 10 million people in the United States are affected. Smoking, high blood pressure, family history of ARMD, and poor diet are all risk factors for the development of ARMD.
The macula is the center most part of the retina, and is responsible for the sharp vision that allows us to read and drive. In some people, as the eye ages, deposits develop in the retina (dry ARMD). This can cause the macula to function imperfectly, which leads to blurry vision. Only 10% of patients develop the wet form of ARMD. In this more devastating form, abnormal blood vessels grow in the macula, and when they leak or bleed, severe loss of the central vision often results.
The symptoms of macular degeneration are blurring of the vision, which causes difficulty with reading or driving. Macular degeneration does not cause total blindness because the side vision is not affected.
At Akler Eye Center in Dearborn MI, a complete eye examination including dilation of the pupil will allow Dr. Akler to detect both mild and severe forms of macular degeneration. If ARMD is found, further testing may include a fluorescein angiogram and optical coherence tomography (OCT). Fluorescein angiography involves injecting dye into the arm and photographing it as it circulates in the retina. Abnormal blood vessel growth and leakage may be detected. OCT is a computerized picture of the macula that shows if it is swollen with fluid. Both of these tests are performed onsite.
Treatments for macular degeneration are primarily targeted at keeping the retina as healthy as possible and screening for early signs of the wet form of ARMD. A study performed by the National Eye Institute demonstrated that taking special vitamins for the eye that contain anti-oxidants (A, C, E and beta-carotene with zinc) reduces the risk of developing severe vision loss. A home screening tool known as an Amsler Grid allows the patient to check the vision with one eye at a time. If the grid paper lines are wavy or faded, an eye examination is needed urgently.
If the wet form of ARMD is present, the current treatment involves injection of medication into the eye. The medication is targeted at reducing the growth of abnormal blood vessels in the macula.
Dr. Michelle Akler recommends regular eye examinations to screen for macular degeneration, especially in older patients and those with a family history of ARMD. Early detection and treatment allows for the best visual outcome in this difficult condition.
Macular degeneration, or Age-Related Macular Degeneration (ARMD) is a condition related to aging of the eye that causes loss of the central vision. It is the commonest cause of blindness in Americans over 55 years old. Approximately 10 million people in the United States are affected. Smoking, high blood pressure, family history of ARMD, and poor diet are all risk factors for the development of ARMD.
The macula is the center most part of the retina, and is responsible for the sharp vision that allows us to read and drive. In some people, as the eye ages, deposits develop in the retina (dry ARMD). This can cause the macula to function imperfectly, which leads to blurry vision. Only 10% of patients develop the wet form of ARMD. In this more devastating form, abnormal blood vessels grow in the macula, and when they leak or bleed, severe loss of the central vision often results.
The symptoms of macular degeneration are blurring of the vision, which causes difficulty with reading or driving. Macular degeneration does not cause total blindness because the side vision is not affected.
At Akler Eye Center in Dearborn MI, a complete eye examination including dilation of the pupil will allow Dr. Akler to detect both mild and severe forms of macular degeneration. If ARMD is found, further testing may include a fluorescein angiogram and optical coherence tomography (OCT). Fluorescein angiography involves injecting dye into the arm and photographing it as it circulates in the retina. Abnormal blood vessel growth and leakage may be detected. OCT is a computerized picture of the macula that shows if it is swollen with fluid. Both of these tests are performed onsite.
Treatments for macular degeneration are primarily targeted at keeping the retina as healthy as possible and screening for early signs of the wet form of ARMD. A study performed by the National Eye Institute demonstrated that taking special vitamins for the eye that contain anti-oxidants (A, C, E and beta-carotene with zinc) reduces the risk of developing severe vision loss. A home screening tool known as an Amsler Grid allows the patient to check the vision with one eye at a time. If the grid paper lines are wavy or faded, an eye examination is needed urgently.
If the wet form of ARMD is present, the current treatment involves injection of medication into the eye. The medication is targeted at reducing the growth of abnormal blood vessels in the macula.
Dr. Michelle Akler recommends regular eye examinations to screen for macular degeneration, especially in older patients and those with a family history of ARMD. Early detection and treatment allows for the best visual outcome in this difficult condition.
Monday, December 27, 2010
Treatment For Wet Macular Degeneration in Seniors
by: Admin
The National Eye Institute (NEI) had published their facts about Age-Related Macular Degeneration (ARMD) to help patients and their family members to search for general information about the disease.
Age Related Wet Macular Degeneration
In its attempt to ensure better public understanding of the disease, it had detailed the ARMD by starting on its definition. The NEI defined ARMD as “a disease associated with aging that gradually destroys sharp, central vision.” It is then explained that central vision is important to see fine details and helps common daily tasks such as reading and driving. It has to be noted that ARMD causes no physical pain to the patients.
There are two types of ARMD, which is the dry and the wet ARMD. In most cases, elderly adults develop the dry ARMD and it is the most common form of the disease, with some of them progressing into wet ARMD when abnormal blood vessels start developing and ruptures within. Wet ARMD can be treated, but not fully cured, by laser surgery, photodynamic therapy and injections into the eye. These treatments may actually just delay the process of being legally blind, but patients need to be aware that conditions will continue to worsen over time.
Treating wet ARMD with Laser surgery is a procedure which utilizes the laser technology to destroy fragile, leaky blood vessels that had formed abnormally. A high energy light beam is directly focused on the new blood vessels, and it destroys them to prevent further loss of vision. The negative side of this treatment is that it potentially destroys other healthy cells surrounding the treatment area.
Only a small percentage of patients may use laser to treat wet ARMD. The procedure is performed at the doctor’s office or an eye clinic, and laser is more effective if the abnormal, leaky blood vessels are developed away from the middle of the macula, which is called the fovea. It does not mean that the abnormal blood vessels will automatically stop developing after laser surgery, in fact repeated treatments are necessary as the risk of developing new abnormal blood vessels post surgery is high. In some cases, the patient may still suffer vision loss progressively despite repeated treatments.
Another treatment, called the photodynamic therapy, involves the injection of a drug called verteporfin into the patient’s arm, and it travels throughout the body including the new blood vessels in the eye. The drug will attach itself to the surface of new blood vessels. After this, the doctor shines a light into the patients eye for about 90 seconds to activate the drug. The drug, once activated, will destroy the new blood vessels and helps slower down the rate of vision decline. It is topical and aims only at the new blood vessels, so it does not destroy surrounding healthy tissues and cells like the laser surgery.
However, caution has to be taken with the use of this drug. As it gets activated by lights, patient has to avoid going outdoors, or exposing skin or eye to direct sunlight or bright indoor lights for five days after treatment. Remember that the drug is administered through injection on the patient’s arm, and the fact that it travels throughout the body instead of being contained within the eye.
This treatment is basically painless, and can be performed at the doctor’s office in about 20 minutes. However, while it slows down the rate of vision loss, it does not stop vision loss, or restore the patient’s vision if it was already damaged by ARMD. Again, this technique will require repeated treatments as necessary, based on the doctor’s prescription and the progress of your condition.
Another treatment is the use of injection, this time with new drugs that are injected directly into the eyes. The anti-VEGF therapy will see these new drugs block the effects of the specific growth factor that triggers the abnormal blood vessels. Multiple injections will be required, and it can be a monthly affair. Before injection, the eyes are numbed. After injection, the patient will be kept at the doctor’s office for a while so that the doctor may monitor the progress of the eyes before declaring that the patient is safe to go home. It is said that this treatment helps slow down vision loss from ARMD and may also help to improve the sight of patients in some cases.
In any of these treatments, the patient should listen to the doctor because the doctor will know the best option available for each individual.
The National Eye Institute (NEI) had published their facts about Age-Related Macular Degeneration (ARMD) to help patients and their family members to search for general information about the disease.
Age Related Wet Macular Degeneration
In its attempt to ensure better public understanding of the disease, it had detailed the ARMD by starting on its definition. The NEI defined ARMD as “a disease associated with aging that gradually destroys sharp, central vision.” It is then explained that central vision is important to see fine details and helps common daily tasks such as reading and driving. It has to be noted that ARMD causes no physical pain to the patients.
There are two types of ARMD, which is the dry and the wet ARMD. In most cases, elderly adults develop the dry ARMD and it is the most common form of the disease, with some of them progressing into wet ARMD when abnormal blood vessels start developing and ruptures within. Wet ARMD can be treated, but not fully cured, by laser surgery, photodynamic therapy and injections into the eye. These treatments may actually just delay the process of being legally blind, but patients need to be aware that conditions will continue to worsen over time.
Treating wet ARMD with Laser surgery is a procedure which utilizes the laser technology to destroy fragile, leaky blood vessels that had formed abnormally. A high energy light beam is directly focused on the new blood vessels, and it destroys them to prevent further loss of vision. The negative side of this treatment is that it potentially destroys other healthy cells surrounding the treatment area.
Only a small percentage of patients may use laser to treat wet ARMD. The procedure is performed at the doctor’s office or an eye clinic, and laser is more effective if the abnormal, leaky blood vessels are developed away from the middle of the macula, which is called the fovea. It does not mean that the abnormal blood vessels will automatically stop developing after laser surgery, in fact repeated treatments are necessary as the risk of developing new abnormal blood vessels post surgery is high. In some cases, the patient may still suffer vision loss progressively despite repeated treatments.
Another treatment, called the photodynamic therapy, involves the injection of a drug called verteporfin into the patient’s arm, and it travels throughout the body including the new blood vessels in the eye. The drug will attach itself to the surface of new blood vessels. After this, the doctor shines a light into the patients eye for about 90 seconds to activate the drug. The drug, once activated, will destroy the new blood vessels and helps slower down the rate of vision decline. It is topical and aims only at the new blood vessels, so it does not destroy surrounding healthy tissues and cells like the laser surgery.
However, caution has to be taken with the use of this drug. As it gets activated by lights, patient has to avoid going outdoors, or exposing skin or eye to direct sunlight or bright indoor lights for five days after treatment. Remember that the drug is administered through injection on the patient’s arm, and the fact that it travels throughout the body instead of being contained within the eye.
This treatment is basically painless, and can be performed at the doctor’s office in about 20 minutes. However, while it slows down the rate of vision loss, it does not stop vision loss, or restore the patient’s vision if it was already damaged by ARMD. Again, this technique will require repeated treatments as necessary, based on the doctor’s prescription and the progress of your condition.
Another treatment is the use of injection, this time with new drugs that are injected directly into the eyes. The anti-VEGF therapy will see these new drugs block the effects of the specific growth factor that triggers the abnormal blood vessels. Multiple injections will be required, and it can be a monthly affair. Before injection, the eyes are numbed. After injection, the patient will be kept at the doctor’s office for a while so that the doctor may monitor the progress of the eyes before declaring that the patient is safe to go home. It is said that this treatment helps slow down vision loss from ARMD and may also help to improve the sight of patients in some cases.
In any of these treatments, the patient should listen to the doctor because the doctor will know the best option available for each individual.
Monday, December 20, 2010
Zeaxanthin For Macular Degeneration Prevention and Treatment in Dry AMD
by The Pulitzer
Most ophthalmologists recommend the antioxidants lutein and zeaxanthin for macular degeneration that is age related, commonly referred to as AMD. It is unusual for doctor’s to recommend nutritional supplements of any kind, unless a person has an outright deficiency, but AMD is a unique condition.
There are no effective treatments for one type of AMD (dry), but there are some partially effective treatments for wet AMD. Together, these two are the major causes of blindness in the elderly. The wet form is the most severe, if not treated early.
In wet AMD, blood vessels grow up and behind the retina, an area responsible for gathering light and transmitting signals to the brain, resulting in sight. The blood vessels often rupture and leak blood and protein below the macula, a very sensitive area within the retina.
Eventually, bleeding, leaking and scarring causes irreversible damage to the light receptors (rods and cones). Rapid vision loss is experienced if it is left untreated. Laser treatment and drugs that inhibit blood vessel growth are usually recommended.
Generally, doctors recommend lutein and zeaxanthin for macular degeneration that is of the dry type. Dry AMD is much more common than wet. It is caused by a build up of yellow deposits called drusen on the retina.
In nature lutein and zeaxanthin are pigments or colors. They are normally present in the retina, with zeaxanthin being concentrated in the macula and lutein more highly concentrated in the periphery of the retina. There roles within the eye are not well understood, but they seem to help reduce or prevent the build up of drusen.
Drusen is similar in composition to the deposits that are found in the brains of Alzheimer’s patients and the plaque that is present in atherosclerosis. People with either of those two conditions have a higher risk of developing dry AMD.
Some doctors recommend taking lutein and zeaxanthin for macular degeneration prevention, particularly to their patients that have a family history of the disease. But, since the drusen are similar to the deposits that cause Alzheimer’s and heart disease, other antioxidants may be beneficial, as well.
Curcumin, an antioxidant present in the spice turmeric, is currently being studied for its benefit in Alzheimer’s disease. Not only does it prevent the accumulation of the plaque, it breaks it up. It might be able to break up the drusen in AMD, too.
One study indicates that the ideal combination of nutrients is omega 3 fatty acids, beta carotene, vitamin E, lutein and zeaxanthin for macular degeneration. Omega 3 fatty acids, particularly DHA, are the most abundant fatty acids present in the retina. Beta-carotene is converted by the body to vitamin A, which is essential for good vision. Vitamin E is well-known for its antioxidant activity.
Prevention is worth a pound of cure, they say. In order to prevent AMD, people should lower their total fat intake, and increase their nutrient intake. This may help reduce the risk of many other diseases, as well. Taking zeaxanthin for macular degeneration prevention is a good idea. Taking a multi-nutritional supplement that contains it, is a great one.
Valerie Rosenbaum researches omega 3 fish oil supplements, anti aging supplements and natural skincare products. Through her research she has discovered the best anti aging supplement, in both quality and value, available today.
Most ophthalmologists recommend the antioxidants lutein and zeaxanthin for macular degeneration that is age related, commonly referred to as AMD. It is unusual for doctor’s to recommend nutritional supplements of any kind, unless a person has an outright deficiency, but AMD is a unique condition.
There are no effective treatments for one type of AMD (dry), but there are some partially effective treatments for wet AMD. Together, these two are the major causes of blindness in the elderly. The wet form is the most severe, if not treated early.
In wet AMD, blood vessels grow up and behind the retina, an area responsible for gathering light and transmitting signals to the brain, resulting in sight. The blood vessels often rupture and leak blood and protein below the macula, a very sensitive area within the retina.
Eventually, bleeding, leaking and scarring causes irreversible damage to the light receptors (rods and cones). Rapid vision loss is experienced if it is left untreated. Laser treatment and drugs that inhibit blood vessel growth are usually recommended.
Generally, doctors recommend lutein and zeaxanthin for macular degeneration that is of the dry type. Dry AMD is much more common than wet. It is caused by a build up of yellow deposits called drusen on the retina.
In nature lutein and zeaxanthin are pigments or colors. They are normally present in the retina, with zeaxanthin being concentrated in the macula and lutein more highly concentrated in the periphery of the retina. There roles within the eye are not well understood, but they seem to help reduce or prevent the build up of drusen.
Drusen is similar in composition to the deposits that are found in the brains of Alzheimer’s patients and the plaque that is present in atherosclerosis. People with either of those two conditions have a higher risk of developing dry AMD.
Some doctors recommend taking lutein and zeaxanthin for macular degeneration prevention, particularly to their patients that have a family history of the disease. But, since the drusen are similar to the deposits that cause Alzheimer’s and heart disease, other antioxidants may be beneficial, as well.
Curcumin, an antioxidant present in the spice turmeric, is currently being studied for its benefit in Alzheimer’s disease. Not only does it prevent the accumulation of the plaque, it breaks it up. It might be able to break up the drusen in AMD, too.
One study indicates that the ideal combination of nutrients is omega 3 fatty acids, beta carotene, vitamin E, lutein and zeaxanthin for macular degeneration. Omega 3 fatty acids, particularly DHA, are the most abundant fatty acids present in the retina. Beta-carotene is converted by the body to vitamin A, which is essential for good vision. Vitamin E is well-known for its antioxidant activity.
Prevention is worth a pound of cure, they say. In order to prevent AMD, people should lower their total fat intake, and increase their nutrient intake. This may help reduce the risk of many other diseases, as well. Taking zeaxanthin for macular degeneration prevention is a good idea. Taking a multi-nutritional supplement that contains it, is a great one.
Valerie Rosenbaum researches omega 3 fish oil supplements, anti aging supplements and natural skincare products. Through her research she has discovered the best anti aging supplement, in both quality and value, available today.
Saturday, December 11, 2010
Advance Cell Technology's CEO says Markets Are Just Starting to Appreciate the Significance of Thei
by Advance Cell Technology
The excitement around ACTC comes after a recent series of key positive announcements including the fact that the FDA granted orphan drug status to the micro-cap's patented embryonic stem cell derived treatment for specific forms of Macular Degeneration and blindness (Stargardt's Macular Dystrophy and Dry Age-related Macular Degeneration). The eye conditions destroy the pigmented layer of retina (retinal pigment epithelium) which is the pigmented cell layer just outside the neurosensory retina that nourishes retinal visual cells.
The condition destroys the pigmented layer of retina (retinal pigment epithelium) which is the pigmented cell layer just outside the neurosensory retina that nourishes retinal visual cells. Advanced Cell Technology has shown success introducing the embryonic stem cell derived RPE cells into the eye in animal models and this resulted in 100% improvement with no side effects for more than 220 days. Human clinical trials are expected to start in the first quarter of 2011, and can potentially take only a few weeks to show positive results.
Advanced Cell Technology has shown success introducing the embryonic stem cell derived RPE cells into the eye in animal models and this resulted in 100% improvement with no side effects for more than 220 days. Human clinical trials are expected to start in the first quarter of 2011, and could potentially take only a few weeks to show positive results according to some analysts.
In addition, for only the second time in history (following Geron's therapy for spinal cord injury), the FDA granted approval for clinical trials for a therapy derived from human embryonic stem cells.
William M. Caldwell, Chairman and CEO of ACTC tells BioMedReports that ACTC plans on building upon their orphan drug status and accelerating clinical testing. In addition, they hope to continue showing promising advancements in other forms of regenerative medicine which the company is developing -- most notably its Myoblast program for the treatment of heart failure. The Myoblast program (part of the company's 2007 acquisition of Mytogen, Inc.) has successfully completed Phase I human clinical trials and the FDA has finished reviewing the data, thus allowing Advanced Cell Technology to proceed with a Phase II human clinical trial (in approximately 160 patients) early next year.
BioMedReports: It appears that suddenly your company has a lot of attention given your news developments. What do you make of all the activity in your stock during recent days?
William M. Caldwell, Chairman and CEO of ACTC: The market is starting to appreciate the significance of the FDA approval of our particular therapy. I think they are now beginning to understand the strategy of having filed for an orphan indication designation for Stargardt's Macular Dystrophy (SMD is one of the most common forms of juvenile macular degeneration in the world) and they now realize that that represents the first wave, with potentially huge commercial opportunities in Dry AMD (Dry Age-Related Macular Degeneration reportedly afflicts more than 30 million people worldwide, including an estimated 13-15 million Americans). Both indications do not have viable therapies and so to the extent that our program can make an impact, it's going to not only help a very large patient population, it -- as well as any other therapies that are approved -- will help validate a very large technology.
BioMedReports: Can you help us digest or simplify what some of those implications are?
William M. Caldwell, Chairman and CEO of ACTC: I can certainly try. Right now, Genentech has a drug on the market for Wet AMD [Note: the FDA approved Lucentis in 2006 after a 6-month priority review] and that patient population is substantially less than the Dry AMD component. Their procedure is to apply a needle into the eye every two to three months with their therapy and for that they get some $2500, plus or minus, for each injection. In our particular situation, we are inserting a needle into the eye- which is something that is done all the time, by the way, this isn't something that's foreign to the practitioner that does the application -- but our application takes place only once or possibly twice over the life of the patient. It is our expectation that the therapy which we'll apply will have an impact on either slowing down or arresting the progression of the disease. We've seen that in our animal models. There have been some very dramatic results when we've applied it into animals and we are extremely hopeful that we will see the same types of results when we apply it into humans.
The problem has been that this technology is totally new to the world of medicine. It is an embryonic stem cell derived therapy. It turns out that our cells have been derived utilizing what we call a blastomere technology which means that we have been able to develop those stem cells without any embryo destruction, which somewhat mitigates the issues that have been in the media.
So, we take our particular stem cell therapy -- and remember that the stem cells are converted into a single cell type so there's really no actual stem cells into the therapy that we are applying only a certain cell-type and in this particular case, it's what they call RPE (retinal pigment epithelial) cells. That RPE layer is in the eye between the photoreceptor and the Bruch's membrane. It protects that photoreceptor -- which gives us the ability to see -- and it also nourishes it. With deterioration, all sorts of different diseases occur. One of which is Stargardt's Macular Dystrophy and another of which is Dry AMD. Now, there are certainly different characteristics to those, but to the extent that you can replenish that RPE layer with new, healthy, viable cells you have the opportunity to dramatically impact the deterioration that is occurring within the photoreceptor.
That's a layman's description of what we're doing with respect to that therapy, but more importantly the market implication is such that if you have in excess of ten million patients currently suffering from that disease; which is age related and as we know the baby boomers are getting older. Unfortunately for those of us that are getting into that post fifty-five or sixty year-old age range, those individuals are prime candidates for this disease. That market is fairly significant. There is an opportunity of tremendous magnitude for a company like ours.
BioMedReports: Let's talk about the structure of the company for a bit. There have been some concerns that there are a lot of shares out there and that a company that is set up in this way could suddenly announce something like a reverse-split during a run-up in price like this one. What are your comments in regard to that as far as ACTC goes?
William M. Caldwell, Chairman and CEO of ACTC: I'm an investment banker and I can tell you that it has been my experience that reverse splits for the sake of reverse splits are very problematic. There has to be a rationale behind why someone would do such a thing and it has to be done around some sort of event that is accretive to shareholders and makes logical sense for all the stakeholders. I'm not inclined at all to recommend a reverse split unless that opportunity presented itself. If it does, based upon our charter, we would then have to go to the shareholders for their approval. In that way they would have an opportunity to understand our rationale and determine whether that makes sense for the majority of them. I think that's about all I can say about that subject at this stage.
BioMedReports: Can you talk about any of the upcoming milestones for the company? Some think that is part of the reason for this run-up, that there are some events worth looking forward to on the horizon.
William M. Caldwell, Chairman and CEO of ACTC: I think we've alluded to some things a couple of times either on blogs or in conferences, and I can start with the approval of our IND for Stargardt's Disease which we will be seeing some time in the first half of the coming year. (That will mark) us going into the clinic. And we have already alluded to the fact that we will go into multiple sites, not just one particular site, for the reason that we have filed for Phase I/Phase II. For those who are not familiar with that, Phase I really focuses on safety. That's going to be a very, very important piece, not just because of the safety, but because it will ensure for the FDA that this cell type can be safe in humans.
You know the first one is always the toughest one, so we've designed the trial to be very, very slow in its evolution. We have a dosage escalation schedule whereby we're only inserting a minimal amount of cells at the outset per patient. Then we will increase that with ensuing patients and we'll pause to allow the FDA to review the results of that so that they can feel comfortable with the safety issues related to the fact that the cells go where they are supposed to go and do what they're supposed to do and that they don't cause any side effects, or tumors or anything else that has been ballyhooed around. By the way, we have never, in any of our studies, ever seen that.
So, I can't speak for others, but for us; our patented differentiation processes are such that our cells are terminally and totally differentiated into the cell type that we're dealing with. Once we do that, then we'll move quickly into efficacy and that tells us, of course, "does it work?" And that's why we're starting out with multiple sites. Right now, I'm in the process of finalizing those sites and developing a relationship with the primary investigator -- the surgeon at each of the sites. I'm working with the internal review boards to gain approval on the protocols on any specific issues that they may have relative to their particular situation and then we will initiate those trials when all of that is completed.
The second major milestone is that we've filed a second IND. That one is for the Dry AMD and we anticipate that it will take much less time for the FDA to evaluate that, versus the time they took to evaluate the first one. We anticipate that sometime in the first quarter (of 2011) there is a very reasonable chance that we will see approval for that IND -- at which time we will then initiate trials for that program as well. Just so you know, it's the same cells. So we're really just taking the same cell-type and treating a different disease-type. So that's why we're relatively bullish on that particular program.
A third area that we've announced is that as big as the market is, and the opportunity is here in the United States, the European community offers a similar opportunity. And with the E.U. controlling the regulatory perspective for the various countries on the continent, we will be looking very hard at the opportunity to take both our Stargardt's and Dry AMD programs over there. I've been spending some time over there trying to ascertain what the best way is to do it and where the best places are to initiate the trials as well as learning a little bit about the process of how to work through the regulatory situations over there. We should be in position to make an announcement about that in the first half of next year.
We've also mentioned another disease condition called our Myoblast or heart program. It's an adult stem cell -- meaning it's the patient's own cells -- in this particular instance. We extract out of the thigh in a biopsy and then we re-place it into the heart with a catheter system. Basically, it goes over the dead heart tissue from a heart attack that a patient has had. And what those cells do, those myoblast cells, is they integrate with the good cardio myocyte cells -- the heart cells -- and help those cells pump the blood in and out of the heart. That's important because when you have a heart attack, part of your heart muscle is killed or dead, and unlike other parts of the body the muscle doesn't regenerate itself and so the remaining muscle has to work harder and the heart becomes a little weaker. Because of the strain on the muscle it gets, sometimes, enlarged. The walls get thinner and that's when you start seeing heart failure. What this does is that it helps mitigate that and the patient can start feeling better. That's really where the FDA is focused on, is the quality of life of the patient. Most of the patients that we're dealing with are in advanced age heart failure. So that is another disease condition. We have gotten approval from the FDA to move out of the Phase I, where we did four trials, and we're moving into Phase II. I've made an announcement that we intend to do that in the first half of next year. So again, that is another program that you should be hearing some things from us about during the first half of next year.
So just in the first half of the coming year we have some fairly significant milestones that we have before us and then there are a couple that we're working on now that we haven't announced yet.
The excitement around ACTC comes after a recent series of key positive announcements including the fact that the FDA granted orphan drug status to the micro-cap's patented embryonic stem cell derived treatment for specific forms of Macular Degeneration and blindness (Stargardt's Macular Dystrophy and Dry Age-related Macular Degeneration). The eye conditions destroy the pigmented layer of retina (retinal pigment epithelium) which is the pigmented cell layer just outside the neurosensory retina that nourishes retinal visual cells.
The condition destroys the pigmented layer of retina (retinal pigment epithelium) which is the pigmented cell layer just outside the neurosensory retina that nourishes retinal visual cells. Advanced Cell Technology has shown success introducing the embryonic stem cell derived RPE cells into the eye in animal models and this resulted in 100% improvement with no side effects for more than 220 days. Human clinical trials are expected to start in the first quarter of 2011, and can potentially take only a few weeks to show positive results.
Advanced Cell Technology has shown success introducing the embryonic stem cell derived RPE cells into the eye in animal models and this resulted in 100% improvement with no side effects for more than 220 days. Human clinical trials are expected to start in the first quarter of 2011, and could potentially take only a few weeks to show positive results according to some analysts.
In addition, for only the second time in history (following Geron's therapy for spinal cord injury), the FDA granted approval for clinical trials for a therapy derived from human embryonic stem cells.
William M. Caldwell, Chairman and CEO of ACTC tells BioMedReports that ACTC plans on building upon their orphan drug status and accelerating clinical testing. In addition, they hope to continue showing promising advancements in other forms of regenerative medicine which the company is developing -- most notably its Myoblast program for the treatment of heart failure. The Myoblast program (part of the company's 2007 acquisition of Mytogen, Inc.) has successfully completed Phase I human clinical trials and the FDA has finished reviewing the data, thus allowing Advanced Cell Technology to proceed with a Phase II human clinical trial (in approximately 160 patients) early next year.
BioMedReports: It appears that suddenly your company has a lot of attention given your news developments. What do you make of all the activity in your stock during recent days?
William M. Caldwell, Chairman and CEO of ACTC: The market is starting to appreciate the significance of the FDA approval of our particular therapy. I think they are now beginning to understand the strategy of having filed for an orphan indication designation for Stargardt's Macular Dystrophy (SMD is one of the most common forms of juvenile macular degeneration in the world) and they now realize that that represents the first wave, with potentially huge commercial opportunities in Dry AMD (Dry Age-Related Macular Degeneration reportedly afflicts more than 30 million people worldwide, including an estimated 13-15 million Americans). Both indications do not have viable therapies and so to the extent that our program can make an impact, it's going to not only help a very large patient population, it -- as well as any other therapies that are approved -- will help validate a very large technology.
BioMedReports: Can you help us digest or simplify what some of those implications are?
William M. Caldwell, Chairman and CEO of ACTC: I can certainly try. Right now, Genentech has a drug on the market for Wet AMD [Note: the FDA approved Lucentis in 2006 after a 6-month priority review] and that patient population is substantially less than the Dry AMD component. Their procedure is to apply a needle into the eye every two to three months with their therapy and for that they get some $2500, plus or minus, for each injection. In our particular situation, we are inserting a needle into the eye- which is something that is done all the time, by the way, this isn't something that's foreign to the practitioner that does the application -- but our application takes place only once or possibly twice over the life of the patient. It is our expectation that the therapy which we'll apply will have an impact on either slowing down or arresting the progression of the disease. We've seen that in our animal models. There have been some very dramatic results when we've applied it into animals and we are extremely hopeful that we will see the same types of results when we apply it into humans.
The problem has been that this technology is totally new to the world of medicine. It is an embryonic stem cell derived therapy. It turns out that our cells have been derived utilizing what we call a blastomere technology which means that we have been able to develop those stem cells without any embryo destruction, which somewhat mitigates the issues that have been in the media.
So, we take our particular stem cell therapy -- and remember that the stem cells are converted into a single cell type so there's really no actual stem cells into the therapy that we are applying only a certain cell-type and in this particular case, it's what they call RPE (retinal pigment epithelial) cells. That RPE layer is in the eye between the photoreceptor and the Bruch's membrane. It protects that photoreceptor -- which gives us the ability to see -- and it also nourishes it. With deterioration, all sorts of different diseases occur. One of which is Stargardt's Macular Dystrophy and another of which is Dry AMD. Now, there are certainly different characteristics to those, but to the extent that you can replenish that RPE layer with new, healthy, viable cells you have the opportunity to dramatically impact the deterioration that is occurring within the photoreceptor.
That's a layman's description of what we're doing with respect to that therapy, but more importantly the market implication is such that if you have in excess of ten million patients currently suffering from that disease; which is age related and as we know the baby boomers are getting older. Unfortunately for those of us that are getting into that post fifty-five or sixty year-old age range, those individuals are prime candidates for this disease. That market is fairly significant. There is an opportunity of tremendous magnitude for a company like ours.
BioMedReports: Let's talk about the structure of the company for a bit. There have been some concerns that there are a lot of shares out there and that a company that is set up in this way could suddenly announce something like a reverse-split during a run-up in price like this one. What are your comments in regard to that as far as ACTC goes?
William M. Caldwell, Chairman and CEO of ACTC: I'm an investment banker and I can tell you that it has been my experience that reverse splits for the sake of reverse splits are very problematic. There has to be a rationale behind why someone would do such a thing and it has to be done around some sort of event that is accretive to shareholders and makes logical sense for all the stakeholders. I'm not inclined at all to recommend a reverse split unless that opportunity presented itself. If it does, based upon our charter, we would then have to go to the shareholders for their approval. In that way they would have an opportunity to understand our rationale and determine whether that makes sense for the majority of them. I think that's about all I can say about that subject at this stage.
BioMedReports: Can you talk about any of the upcoming milestones for the company? Some think that is part of the reason for this run-up, that there are some events worth looking forward to on the horizon.
William M. Caldwell, Chairman and CEO of ACTC: I think we've alluded to some things a couple of times either on blogs or in conferences, and I can start with the approval of our IND for Stargardt's Disease which we will be seeing some time in the first half of the coming year. (That will mark) us going into the clinic. And we have already alluded to the fact that we will go into multiple sites, not just one particular site, for the reason that we have filed for Phase I/Phase II. For those who are not familiar with that, Phase I really focuses on safety. That's going to be a very, very important piece, not just because of the safety, but because it will ensure for the FDA that this cell type can be safe in humans.
You know the first one is always the toughest one, so we've designed the trial to be very, very slow in its evolution. We have a dosage escalation schedule whereby we're only inserting a minimal amount of cells at the outset per patient. Then we will increase that with ensuing patients and we'll pause to allow the FDA to review the results of that so that they can feel comfortable with the safety issues related to the fact that the cells go where they are supposed to go and do what they're supposed to do and that they don't cause any side effects, or tumors or anything else that has been ballyhooed around. By the way, we have never, in any of our studies, ever seen that.
So, I can't speak for others, but for us; our patented differentiation processes are such that our cells are terminally and totally differentiated into the cell type that we're dealing with. Once we do that, then we'll move quickly into efficacy and that tells us, of course, "does it work?" And that's why we're starting out with multiple sites. Right now, I'm in the process of finalizing those sites and developing a relationship with the primary investigator -- the surgeon at each of the sites. I'm working with the internal review boards to gain approval on the protocols on any specific issues that they may have relative to their particular situation and then we will initiate those trials when all of that is completed.
The second major milestone is that we've filed a second IND. That one is for the Dry AMD and we anticipate that it will take much less time for the FDA to evaluate that, versus the time they took to evaluate the first one. We anticipate that sometime in the first quarter (of 2011) there is a very reasonable chance that we will see approval for that IND -- at which time we will then initiate trials for that program as well. Just so you know, it's the same cells. So we're really just taking the same cell-type and treating a different disease-type. So that's why we're relatively bullish on that particular program.
A third area that we've announced is that as big as the market is, and the opportunity is here in the United States, the European community offers a similar opportunity. And with the E.U. controlling the regulatory perspective for the various countries on the continent, we will be looking very hard at the opportunity to take both our Stargardt's and Dry AMD programs over there. I've been spending some time over there trying to ascertain what the best way is to do it and where the best places are to initiate the trials as well as learning a little bit about the process of how to work through the regulatory situations over there. We should be in position to make an announcement about that in the first half of next year.
We've also mentioned another disease condition called our Myoblast or heart program. It's an adult stem cell -- meaning it's the patient's own cells -- in this particular instance. We extract out of the thigh in a biopsy and then we re-place it into the heart with a catheter system. Basically, it goes over the dead heart tissue from a heart attack that a patient has had. And what those cells do, those myoblast cells, is they integrate with the good cardio myocyte cells -- the heart cells -- and help those cells pump the blood in and out of the heart. That's important because when you have a heart attack, part of your heart muscle is killed or dead, and unlike other parts of the body the muscle doesn't regenerate itself and so the remaining muscle has to work harder and the heart becomes a little weaker. Because of the strain on the muscle it gets, sometimes, enlarged. The walls get thinner and that's when you start seeing heart failure. What this does is that it helps mitigate that and the patient can start feeling better. That's really where the FDA is focused on, is the quality of life of the patient. Most of the patients that we're dealing with are in advanced age heart failure. So that is another disease condition. We have gotten approval from the FDA to move out of the Phase I, where we did four trials, and we're moving into Phase II. I've made an announcement that we intend to do that in the first half of next year. So again, that is another program that you should be hearing some things from us about during the first half of next year.
So just in the first half of the coming year we have some fairly significant milestones that we have before us and then there are a couple that we're working on now that we haven't announced yet.
Tuesday, December 7, 2010
Vitamin C For Macular Degeneration
by Admin
Some of the vitamins that can help when it comes to protecting eyesight and reducing or preventing age macular degeneration includes Vitamin C, E, Thiamine, Riboflavin, B-6, B12, Folic Acid, Niacin, Zinc, L-Taurine, Manganese, Copper, Selenium, Calcium, L-Glutathione, Rutin, Lycopene and Lutein. All of these vitamins have properties that help to increase eye health and increase the body’s ability to reduce the effects of macular degeneration for example these vitamins may help in the reduction of blood vessels or the reduction of Drusen that buildup between the macula and the retina. Improving your eyesight can also help to reduce symptoms in the beginning stages of macular degeneration.
Some of the vitamins that can help when it comes to protecting eyesight and reducing or preventing age macular degeneration includes Vitamin C, E, Thiamine, Riboflavin, B-6, B12, Folic Acid, Niacin, Zinc, L-Taurine, Manganese, Copper, Selenium, Calcium, L-Glutathione, Rutin, Lycopene and Lutein. All of these vitamins have properties that help to increase eye health and increase the body’s ability to reduce the effects of macular degeneration for example these vitamins may help in the reduction of blood vessels or the reduction of Drusen that buildup between the macula and the retina. Improving your eyesight can also help to reduce symptoms in the beginning stages of macular degeneration.
Sunday, November 28, 2010
Retinal Disease Treatments Double Over 10 Years
by:Jen Blackstock
When most people think of diabetes, the first thing to come to mind is rarely blindness, yet blindness is a very real complication of diabetes: Diabetes is actually the number one cause of new blindness in the United States.
Diabetic retinopathy happens when diabetes damages the tiny blood vessels inside the retina, which therefore stop feeding the retina properly, according to the American Foundation for the Blind. Symptoms can include blurry or double vision; rings, flashing lights or blank spots; dark or floating spots; pain or pressure in one or both of your eyes; and trouble seeing things out of the corners of your eyes. Forty percent of people with diabetes have some form of diabetic retinopathy.
With the rise in the number of people with diabetes and the aging American population, it is no surprise that the number of older Americans undergoing treatment for retinal conditions such as age-related macular degeneration (AMD) and diabetic retinopathy increased 192 percent between 1997 and 2007. Additionally, there has been a significant shift in the types of procedures being performed, a new study has found.
Age-related macular degeneration is a progressive disease of the retina that causes the loss of central vision. Both age-related macular degeneration and diabetic retinopathy can cause vision loss and blindness.
The study analyzed Medicare data from 1997 to 2007 and found that the number of retinal procedures increased 192 percent during that period. The largest year-to-year increase (20 percent) occurred between 2006 and 2007, according to the study published in the October issue of the journal Archives of Ophthalmology.
In terms of actual procedures performed, the largest increase was in treatments for neovascular, or "wet," AMD. New treatments for this condition include intravitreal therapy, or drug injections directly into the eye, of antibodies that block the formation of new blood vessels. From 1997 to 2001, only 5,000 of these procedures were performed each year. By 2007, the number had jumped to 812,413. Also increasing is the use of vitrectomy, a surgery to remove the gel inside the eye in order to treat retinal detachment -- increased 72 percent between 1997 and 2007.
"Retinal disease is highly prevalent among older individuals, and both age-related macular degeneration and diabetic retinopathy account for more than half the irreversible blindness in older Americans. The prevalence of both macular degeneration and diabetic retinopathy increases with age, and the number of Americans affected by these conditions is expected to increase substantially as the number of Americans older than 65 years doubles from 2010 to 2040," says study author Dr. Pradeep Ramulu, of Wilmer Eye Institute at Johns Hopkins University in Baltimore.
With the rise of cases of diabetes and the aging of the baby boomer population in the United States, eye care and blindness prevention is becoming increasingly important within the medical community.
When most people think of diabetes, the first thing to come to mind is rarely blindness, yet blindness is a very real complication of diabetes: Diabetes is actually the number one cause of new blindness in the United States.
Diabetic retinopathy happens when diabetes damages the tiny blood vessels inside the retina, which therefore stop feeding the retina properly, according to the American Foundation for the Blind. Symptoms can include blurry or double vision; rings, flashing lights or blank spots; dark or floating spots; pain or pressure in one or both of your eyes; and trouble seeing things out of the corners of your eyes. Forty percent of people with diabetes have some form of diabetic retinopathy.
With the rise in the number of people with diabetes and the aging American population, it is no surprise that the number of older Americans undergoing treatment for retinal conditions such as age-related macular degeneration (AMD) and diabetic retinopathy increased 192 percent between 1997 and 2007. Additionally, there has been a significant shift in the types of procedures being performed, a new study has found.
Age-related macular degeneration is a progressive disease of the retina that causes the loss of central vision. Both age-related macular degeneration and diabetic retinopathy can cause vision loss and blindness.
The study analyzed Medicare data from 1997 to 2007 and found that the number of retinal procedures increased 192 percent during that period. The largest year-to-year increase (20 percent) occurred between 2006 and 2007, according to the study published in the October issue of the journal Archives of Ophthalmology.
In terms of actual procedures performed, the largest increase was in treatments for neovascular, or "wet," AMD. New treatments for this condition include intravitreal therapy, or drug injections directly into the eye, of antibodies that block the formation of new blood vessels. From 1997 to 2001, only 5,000 of these procedures were performed each year. By 2007, the number had jumped to 812,413. Also increasing is the use of vitrectomy, a surgery to remove the gel inside the eye in order to treat retinal detachment -- increased 72 percent between 1997 and 2007.
"Retinal disease is highly prevalent among older individuals, and both age-related macular degeneration and diabetic retinopathy account for more than half the irreversible blindness in older Americans. The prevalence of both macular degeneration and diabetic retinopathy increases with age, and the number of Americans affected by these conditions is expected to increase substantially as the number of Americans older than 65 years doubles from 2010 to 2040," says study author Dr. Pradeep Ramulu, of Wilmer Eye Institute at Johns Hopkins University in Baltimore.
With the rise of cases of diabetes and the aging of the baby boomer population in the United States, eye care and blindness prevention is becoming increasingly important within the medical community.
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