We have injected another patient with Stargardts, PR was released yesterday. I'm still waiting on for more AMD patients...
ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from Embryonic Stem Cells
Final Patient from First Cohort in Phase I//II Trial Using hESC-Derived RPE Cells
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Wills Eye Institute in Philadelphia has received institutional review board (IRB) approval as a site for the company’s Phase I/II clinical trial for Stargardt’s Macular Dystrophy (SMD), a form of juvenile macular degeneration, using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells. Earlier this year, the Company also announced that the IRB at Wills Eye Institute had approved the participation of the institution as a site for ACT’s clinical trial for dry age-related macular degeneration (dry AMD).
“We thank Wills Eye Institute once more for providing their IRB and their invaluable contribution to our macular degeneration studies,” said Gary Rabin, ACT’s chairman and CEO. “We are very happy that we can now report that Wills Eye Institute has been approved as a clinical trial site for both our SMD and dry AMD clinical trials. Ranked as one of the best ophthalmology hospitals in the country by U.S. News & World Report, the Wills Eye Institute is a truly world-class institution. Our team is eagerly anticipating working with Dr. Carl Regillo, a renowned retinal surgeon and director of clinical retina research at Wills Eye Institute, as well as a professor of ophthalmology at Thomas Jefferson University, along with the rest of his team as we move forward with these ground-breaking trials.”
The Phase I/II trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of the hESC-derived RPE cells following sub-retinal transplantation into patients with SMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format. Preliminary results relating to both early safety and biological function for the first two patients in the U.S., one SMD patient and one dry AMD patient, were recently reported in The Lancet.
Specific patient enrollment for both trials at the Wills Eye Institute will be determined in the near future. Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov ; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.
StemCells INC recently recieved FDA approval for phase 1/2 trial for AMD, from what i am gathering their methods are not
as capable as ACT's. I will post details a little later today.( http://www.modernmedicine.com/modernmedicine/ModernMedicine+Now/Stem-cells-cleared-for-AMD-clinical-trial/ArticleStandard/Article/detail/758797?contextCategoryId=40207)
press release
Feb. 15, 2012, 8:20 a.m. EST
NEW YORK, NY, Feb 15, 2012 (MARKETWIRE via COMTEX) -- Stem cell stocks have performed well of late, outperforming the S&P 500 by a large margin over the last three months. Since mid-November, TickerSpy's Stem Cell Stocks index (RXSTM) has returned more than 20 percent, as favorable news from some of stem cell industry heavyweights has boosted investor optimism in the sector. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Advanced Cell Technology, Inc. /quotes/zigman/383136 ACTC -0.99% and StemCells Inc. /quotes/zigman/5728491/quotes/nls/stem STEM -7.90% . Access to the full company reports can be found at:
Shares of StemCells Inc. have skyrocketed nearly 20 percent year-to-date. StemCells Inc. is focused on cellular medicine, or the use of stem and progenitor cells as the basis for therapeutics and therapies, and enabling technologies for stem cell research, or the use of cells and related technologies to enable stem cell-based research and drug discovery and development.
Earlier this month the company released a statement saying that it received U.S. Food and Drug Administration authorization to start a clinical trial of the company's potential treatment for dry age-related macular degeneration, or AMD. AMD is the leading cause of vision loss and blindness in people over 55 years old and about 30 million people worldwide are affected by the disease, the company said
The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.
Shares of Advanced Cell Technology are up more than 30 percent this year - although they are down more than 20 percent over the last month. Advanced Cell Technology has acquired, developed and maintained a portfolio of patents and patent applications that forms the base for its research and development efforts in the area of embryonic and adult stem cell research.
Earlier this week Advanced Cell Technology announced that a third patient has been treated for Stargardt's macular dystrophy in its US. Phase I/II clinical trial. The therapy uses retinal pigment epithelial cells derived from human embryonic stem cells. Stargardt's disease or Stargardt's Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age.
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OK, a few thoughts on STEM's trial for AMD compared with ACTC's :
ACTS HESC RPE Cells ( Thats human embryonic stem cells and retinal pigment epithelial cells for those of you still doing your DD) are derived using ACTC's patented "blastomere technique". Which means we can successfullu generate hESC with zero harm to the embryo.
Compared to STEMS hCNS-SCns cells (human neural stem cells) are neural stem cells taken from embryos.
And as we have seen with our published results, ACTC's cell treatment actually reversed vision loss. Opposed to STEM who's method has the following results in animal models thus far: "The purified human neural stem cell transplants significantly protected against the degeneration of photoreceptors, and the number of cone photoreceptors remained constant over an extended period, consistent with the sustained visual acuity and light sensitivity observed"
So otherwords, Stems method merley halts the progression of the disease and attempts to sustain what vision remains... Contrasted with ACTC who has not only halted vision loss, but reversed it in human trials.
IMO ACTC has the superior method, and our further success in trials will bulster our lead in the field.
Our CEO Gary Rabin has posted a new message on TheChairmansBlog , heres some good news on moving forward with our AMD patients... See below:
2/16/2012
Greetings,
As you are undoubtedly aware, last July we initiated the first-ever clinical trials using a cell therapy derived from human embryonic stem cells (hESCs) to treat various forms of macular degeneration. The end goal for our clinical trials is to test whether or not the retinal pigment epithelial (RPE) cells we make from hESCs are capable of homing to sites of injury in the retina, replacing the native RPE cells that are lost to disease, and ultimately reestablishing the function of this layer of cells in protecting photoreceptors from cell death, i.e. slowing or halting progressive vision loss. One of our ongoing trials is for Stargardt’s Macular Dystrophy (SMD, aka Stargardt’s Disease) and the other is for Dry Age-Related Macular Degeneration (Dry AMD). Last month we also initiated a European clinical trial for Stargardt’s Disease. That same week, we also published some exciting – albeit very preliminary data – relating to the patients treated last July, in The Lancet.
To date, we have treated one patient with Dry AMD (at UCLA), and a total of four patients with SMD (three at UCLA, and one at Moorfields Eye Hospital in London). The recent treatment of the two SMD patients at UCLA represents the entire first cohort of patients for this initial dose of cells in the SMD trial.
We are pleased to have both trials underway and delighted with the results we have reported so far. Clearly, though, the question arises: why does the Stargardt’s Disease trial appear to be moving along at a faster pace than the Dry AMD trial? This has no doubt been of particular interest to our investors, upon whom the vast size of the potential market for Dry AMD is not lost; a projected market upwards of $25-30 Billion in the US and Europe alone. I intend to briefly address this issue here.
No Two Trials Alike
No two clinical trials are exactly alike or proceed at exactly the same pace. There are a few reasons why patient treatment in our Dry AMD trial has lagged behind our SMD trial a bit. It can be summed up pretty much as follows: luck, age and regulatory factors.
Any large-scale, complex project with a number of moving parts and other variables, no matter how well planned and thought through, is on some level affected by a random interplay of factors beyond the control of its planners. Clinical trials are no exception to this, and simple luck always comes into play on some level.
In the case of the Dry AMD trial, four of the initial patients that principal investigator Dr. Steven Schwartz of UCLA had identified as good candidates from which to select patients two and three wound up being screened out of eligibility in the final battery of tests. The patients all passed initial health screenings, complete reviews of their medical records and extensive optical analyses. Sadly, on the eve of the surgeries, the longer lead time screenings for cancer and viral infections yielded previously unidentified positive results. These patients had surely been excited to participate in the trial, and my heart goes out to each of them. They have suffered already with blindness from macular degeneration, and now have another tough set of circumstances to deal with in their lives.
This is, unfortunately, not an overly uncommon occurrence in clinical trials, but clearly it is more likely to happen in a trial with a patient population that tends to be elderly, by definition. Dry AMD is, after all, age-related, and an older patient population will invariably have more complicating health factors that could affect final eligibility to participate in a clinical trial.
The Food and Drug Administration’s (FDA) protocol for our surgeries, as you are also likely aware, involves a course of immune suppression before and for a period of time after the transplant, and a patient’s ability to tolerate this without other adverse effects is a critical factor in inclusion in the study. The extremely poor visual acuity requirements in the FDA protocol result in a decidedly elderly patient population (with patients typically being 77 years old or so at the youngest). When that factor is combined with the requirement of an intact Bruch’s Membrane, and the general health-related restrictions mentioned above, it makes for a more challenging patient screening process in the dry AMD trial relative to that for the SMD trial.
That being said, I am pleased to inform you that we are currently in the advanced stages of screening several more clinical trial candidates and are very confident that we will soon be able to treat two additional Dry AMD patients, rounding out the first cohort in the AMD trial.
Thank you, as always, for your interest and support.
Gary Rabin
Chairman and CEO
Advanced Cell Technology, Inc.
The Company also announced today that it expects to shortly file a preliminary proxy statement with the Securities and Exchange Commission in which it will seek shareholder approval for a reverse split of between 1-for 20 and 1-for 80 shares. The Company is pursuing the reverse split for the sole purpose of meeting the requirements necessary for a listing on the Nasdaq Global Market. The Company believes that a listing on a national change will allow it to expand its shareholder base and improve the marketability of its common stock by attracting a broader range of investors."
I know i mentioned above i was going to stay out until after the Reverse Split, but i couldn't help but jump in, the price is just too low... I bought about 10k shares in my Roth IRA . Also, this stock sometimes can correspond with momentum of other stem cell stocks, with the upward trend in STEM ( Up over 100% in the last week or so) ACTC could benefit.
New Australian Patent Covers Human RPE Cells Made From Range of Pluripotent Stem Cells, Including Both Embryonic Stem Cells and induced Pluripotent Stem (iPS) Cells
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has been issued a patent in Australia, patent number 2005325753, “Improved modalities for the treatment of degenerative diseases of the retina.” The patent broadly covers the use of human retinal pigment epithelial (RPE) cells generated from pluripotent stem cells in the manufacture of pharmaceutical preparations of RPE cells, and the use of those preparations to treat patients with degenerative diseases of the retina such as Age-related Macular Degeneration. The patent covers the pharmaceutical formulation of human RPE cells made from a range of pluripotent stem cells, including both human embryonic stem cells (hESCs) and human induced pluripotent stem (iPS) cells.
“Our ongoing success in securing broad patent protection around the world, including this newly-issued Australian patent, is a testament to our innovative chief scientific officer, Dr. Robert Lanza, and the rest of our scientific team.”
“We continue to make great progress with our patent estate covering RPE therapies,” said Gary Rabin, chairman and CEO of ACT. “Our ongoing success in securing broad patent protection around the world, including this newly-issued Australian patent, is a testament to our innovative chief scientific officer, Dr. Robert Lanza, and the rest of our scientific team.”
The efficient production of highly pure RPE cell preparations represents a critical step in the creation of renewable sources of transplantable cells that can be used to target degenerative diseases of the eye such as Stargardt’s Macular Dystrophy (SMD) and dry Age-related Macular Degeneration (dry AMD).
“Our current embryonic stem cell trials pave the way for other pluripotent stem cell therapies,” commented Dr. Lanza. “ACT’s cellular reprogramming technologies using iPS cells are in an advanced stage of development, and we hope to be in a position to move toward clinical translation in the not-too-distant future. Since iPS cells can be made from the patient’s own cells such as skin or blood cells they may allow us to expand our cell therapies beyond immune-privileged sites such as the eye without the risk of immune rejection.”
Mr. Rabin concluded, “We are aggressively pursuing patent protection for a variety of aspects of our programs. Our intellectual property strategy includes both vigilance in pursuing comprehensive coverage from our initial patent filings, such as this new Australian patent, and filing for protection around our scientific team’s various innovations. At the same time we are paying close attention to including within our patent coverage those ways others may wish to adapt our technology for commercial use, such as through the choice of stem cell source, or the use of solid supports or cell suspensions for delivery. Following this strategy, we are establishing both formidable barriers-to-entry for potential competitors, as well as strong potential licensing opportunities for others, translating into solid revenue generation possibilities for the company.”
Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the final patient in the first patient cohort in its Phase 1/2 clinical trial for Stargardt's macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Friday, July 27 at Moorfields Eye Hospital in London, the same site as the first two treatments, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London. The outpatient transplant surgery was performed successfully without any complications, and the patient is recovering uneventfully. This is the tenth patient overall to now be treated with the RPE cell therapy developed by the company.
"Our European trial is making very steady progress, having now completed enrollment of the first patient cohort," commented Gary Rabin, chairman and CEO. "We are very encouraged and look forward to receiving clearance to initiate the treatment of the second patient cohort in the coming weeks."
The Phase 1/2 trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the study's primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. It is similar in design to the U.S. trial for SMD that was initiated in July 2011.
"This is a significant month for the company," continued Mr. Rabin. "One year ago we treated the first of our patients in our two U.S. clinical trials. The one-year follow-up for those initial patients indicates that the improvements in visual acuity we initially reported have in fact persisted now for a year. Indeed, we are consistently observing improvements in subjective and objective visual acuity for patients being treated at the various clinical centers involved in our trials. Again, these trials are still at very early stages, but these preliminary results indicate that we are on the right track."
The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has officially designated ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells as an orphan medicinal product for the treatment of SMD.
Here is a must read for any ACTC or Stem Cell investor :
Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in the company's Phase I/II clinical trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Wednesday, Aug. 1 at Wills Eye Institute in Philadelphia, by a surgical team lead by Carl D. Regillo, M.D., Chief of the Wills Eye Institute Retina Service, and professor of ophthalmology at Thomas Jefferson University. The patient was injected with 100,000 hESC-derived RPE cells and is recovering uneventfully.
"We are very pleased to have the second dose cohort in both of our U.S. clinical trials underway," commented Gary Rabin, chairman and CEO of ACT. "We are encouraged by our ongoing progress in all three of our clinical trials using our hESC-derived RPE cells to treat forms of macular degeneration. We have not observed any complications or side effects from the stem cell-derived RPE cells, and we will continue to monitor the patients for safety, tolerability and efficacy of this therapy."
The dry AMD trial is one of three clinical trials being carried out by the company in the U.S. and in Europe. Each trial will enroll 12 patients, with cohorts of three patients in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD or Stargardt's macular dystrophy (SMD) at 12 months, the study's primary endpoint. Preliminary results from the two U.S. trials were reported in The Lancet earlier this year.
"Doubling the cell dosage in both our U.S. trials is an important step forward in our clinical programs," said Robert Lanza, M.D., ACT's chief scientific officer. "We anticipate continued progress and safety findings in both our U.S. trials as well as our concurrent European trial."
"Dry AMD is the most common cause of vision loss in patients over 50 years and affects around 30 million people worldwide," said Dr. Regillo. "Dry AMD is a form of macular degeneration with no approved drug treatment available to date. ACT's hESC-derived RPE cells could address the unmet medical need of combating dry AMD and other macular degenerations such as Stargardt's disease. We are looking forward to analyzing the safety and efficacy data.
Hey Mike,
ACTC is currently in Phase 1/2 Trials for dry age-related macular degeneration (dry AMD) and Stargardt’s Macular Dystrophy (SMD, aka Stargardt’s Disease). you can see the PR's released over the past few weeks as to how they are coming along.
Using the same retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) , they can apply these cells to many different applications... They have a pretty robust pipeline.
The RS will happen , the split ratio has yet to be determined, But this is going to be a (hopefuly) well managed reverse split ... But dont be confused, this is not going to be the standard pink sheet reverse split, where soon after the split the company issues tons of shares and then toxix dillution and the cycle starts over again... They are doing it for the right reasons, the biggest being this is going to allow ACTC to be uplisted to the NASDAQ. This will allow them exposure to investors and funding that just cant be accessed at our current levels and on the OTC.
Short term, This can continue its uptrend with more posiitve news on the trial, expeccially the AMD patients, seeing that is the larger market. I really dont like guessing the share price but we could see .20 or so within the next few months. But, they will want to apply the RS when the stock price is at its highest. So if or when this rises, dont be afraid to take profits.
I highly reccomend you read this artlice : http://seekingalpha.com/article/765071-stem-cell-revolution-an-interview-with-gary-rabin-chairman-and-ceo-of-advanced-cell-technology
Its an interview the CEO , Gary rabin gave last week. Some very good tidbits in there.
