Geron! (WKN 902213) Bitte um Kommentare! @meislo? o. T.
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|Neuester Beitrag:||14.03.04 21:58||von: meislo||Leser gesamt:||3.632|
ich poste in sachen geron eigentlich nur noch bei wallstreet-online, bin aber nach wie vor von geron überzeugt. wenn die letzten monate auch nicht erfolgreich waren, so ist die aktie unter den biotechwerten das absolute highlight. geron weist mit 500 mio dollar natürlich eine ansehnliche marktkapitalisierung auf und hat dadurch auch enormes abwärtspotential aufzuweisen. erst recht wenn der börsenmoteor krepieren sollte. kurse von 3 dolllar würden mich dann nicht überraschen. die geschichte mit der krebsvaccance deren rechte ja nicht bei geron sondern bei merix lagen ist nun geklärt, wenn auch zu einem hohen preis. geron musste ihn aber bezahlen da es derzeit das einzige produkt ist was sich in den klinischen phasen befindet. der focus gerons liegt aber nicht bei immuntherapie. ich stelle mal die news der letzten woche ins board und wenn du willst kannst du ja darauf antworten und oder bei wallstreet- online vorbei schauen.
als highlight ist am freitag noch ein interview mit okarma erschienen was die börse noch nicht antizipiert hat. mal schauen was daraus wird. ich jedenfalls habe es wohlwollend zur kenntnis genommen.
hier die pressemitteilungen wegen der krebsvaccance und den rechten die geron für 5 mio aktien erworben hat
Geron Corporation and Merix Bioscience, Inc. Announce a Co-Exclusive License Agreement for Therapeutic Cancer Vaccines
Wednesday March 10, 7:30 am ET
MENLO PARK, Calif. & DURHAM, N.C.--(BUSINESS WIRE)--March 10, 2004--Geron Corporation (Nasdaq:GERN - News) and Merix Bioscience, Inc. announced today that the companies have executed an agreement under which Geron has acquired the exclusive right to use Merix`s platform technology in therapeutic cancer vaccines using the enzyme telomerase as an antigen. That combination of technologies is used in a Phase I/II clinical trial currently under way at Duke University Medical Center.
Under the agreement, Geron also obtained co-exclusive rights to use the Merix platform technology in cancer vaccines using other defined antigens, while Merix retains co-exclusive rights to use the platform technology with defined antigens other than telomerase and exclusive rights to use it with total tumor RNA and other uncharacterized antigens. In addition, the companies have agreed to a cross licensing arrangement with respect to new technology in the field -- enabling both companies to pursue and share further technological developments. Except for payments that flow through to third party academic licensors, the license acquired by Geron is fully paid up. Under the agreement, Geron issued five million shares of its common stock to Merix.
Representatives of both companies cite the agreement as a positive step toward advancement of cancer therapies.
" During 2003, Geron announced positive results from the Duke Phase I/II clinical trial using the Merix platform technology in combination with our patented telomerase technology," said Thomas B. Okarma, Ph.D., M.D., Geron`s president and chief executive officer. " We believe telomerase is a very important universal and specific cancer target, and the Merix platform technology for charging dendritic cells to present antigens and provoke an immune response is an outstanding vaccine platform. This transaction allows us to go forward with development of these two technologies in combination."
" We are certainly excited by the trial results at Duke that have been reported," said Clint G. (Skip) Dederick, Jr., Chairman and CEO of Merix Bioscience. " This is strong validation of our platform technology and very encouraging as we begin our initial corporate clinical trial using total tumor RNA in metastatic renal cell carcinoma in North America. Our agreement with Geron allows for further development and bodes well for future benefits resulting from both companies` technologies and further research efforts."
Merix holds licenses to several patent families, including one for treating cancer and other diseases using antigen presenting cells loaded with RNA encoding relevant tumor antigens, and another for the ex vivo generation of mature dendritic cells. These methods were used in the Duke Phase I/II prostate cancer trial using telomerase RNA as antigen. Merix also has rights to additional patent applications covering various improvements to the platform, including methods to enhance vaccine potency and to simplify the process of vaccine manufacturing.
Geron has acquired co-exclusive rights to the full collection of Merix controlled intellectual property for use in dendritic cell-based cancer immunotherapy using defined antigens. This enables Geron to continue development of telomerase-based cancer immunotherapies as currently practiced in the Duke trial, as well as to: (i) improve the efficiency and potency of the current vaccine protocol, (ii) apply the platform to other cancer types using other defined antigens (for example, tumor-specific antigens) in combination with telomerase, and (iii) use the Merix platform in combination with dendritic cells from other sources, including human embryonic stem cells.
Telomerase, Dendritic Cells and the Duke Clinical Trial Results
Telomerase is an enzyme found in virtually all cancer cells (and rarely or at very low levels in normal cells). Telomerase acts to enable the immortality of cancer cells by elongating telomeres, the protective structures at the ends of chromosomes. Telomerase activation in cancer cells prevents telomeres from becoming critically short, which would trigger apoptosis and cell death. Telomerase thus conveys unlimited replicative capacity to cancer cells, allowing the cancer to spread throughout the body.
Geron researchers and others have demonstrated that anti-telomerase T-lymphocytes generated in animal models and in human cancer patients can recognize and kill a variety of cancer cell types including renal cell, prostate, breast, bone, multiple myeloma, malignant melanoma, lymphoma, bladder and colon cancers. The telomerase-specific T-cells only recognize telomerase expressing cells.
The preferred method to generate antigen-specific T-lymphocytes is to utilize antigen-loaded and activated dendritic cells. Dendritic cells are cells of the immune system which carry tumor antigens to T-cell-rich areas of lymph nodes where they present antigen to T-lymphocytes and direct their differentiation into cytolytic T-lymphocytes which recognize and kill cells that express the antigen on their surface.
These two platforms, dendritic cell loading/activation and telomerase antigen, are being used together in a Phase I/II trial in patients with advanced prostate cancer at Duke University Medical Center. The preliminary results to date show: (i) no adverse reactions, (ii) high levels of telomerase-specific cytolytic T-cells in all but one vaccinated patient, (iii) clearance or reduction of circulating prostate cancer cells from the blood of patients, and (iv) reduction in some patients of PSA velocity (the rate of PSA rise, a surrogate indicator of increasing tumor burden) both latter effects occurring during the period that the telomerase-specific T-cells were present. These results, although preliminary, suggest that high levels of telomerase-specific killer T-cells can be generated safely in advanced cancer patients and that those T-cells may have beneficial clinical effects on tumor progression.
Merix Bioscience, Inc. is a privately held company headquartered in North Carolina with additional operations in Erlangen, Germany, and is dedicated to becoming a market leader in the field of immunotherapy. Utilizing proprietary technology and proven therapeutic methods and expertise in dendritic cell biology, Merix is developing the next generation of therapies in the areas of oncology, infectious diseases, autoimmune disorders and transplantation. Merix`s initial total tumor RNA-loaded dendritic cell vaccine is currently in a corporate Phase I/II clinical trial for patients with metastatic renal cell carcinoma.
hier die pressemitteilung seitens merix
Merix Bioscience Announces Agreement with Geron Corporation for Development of Cancer Vaccines
3/11/2004 1:56:00 PM
DURHAM, N.C., Mar 11, 2004 (BUSINESS WIRE) -- Durham-based MERIX Bioscience, a company pioneering therapeutic cancer vaccines, has signed a joint licensing agreement with California-based Geron Corporation. The agreement could propel clinical progress and yield faster commercialization of therapeutic cancer vaccines. Clinical testing utilizing the combined technologies is ongoing at Duke University Medical Center in Durham, NC.
CBS MARKETWATCH TOP NEWS
In exchange for five million shares of Geron stock, valued at over $43 million, Merix will allow Geron the use of its platform technology for modifying dendritic cells to present one or more defined antigens in order to provoke an anti-tumor immune response. Merix retains co-exclusive rights to use the platform technology with defined antigens other than Geron`s telomerase antigen and exclusive rights to use it with total tumor RNA and other uncharacterized antigens.
Merix`s platform technology has been validated in several clinical trials at Duke, including the ongoing trial which combines Merix`s antigen delivery technology with the telomerase antigen. " This validation of our technology is especially encouraging as we begin our initial corporate clinical trial using total tumor RNA in metastatic renal cell carcinoma in North America," said Clint G. (Skip) Dederick, Jr., Chairman and CEO of Merix. " We believe that utilizing all of the patient`s tumor antigens (i.e., " total tumor RNA" ) has the unique advantage of inducing the broadest possible immune response, maximizing the chance of effective anti-tumor responses."
The technology used by Merix involves extracting RNA from a cancer patient`s tumor, combining it with dendritic cells also removed from the patient, and reintroducing the now " personalized vaccine" back into the patient. This stimulates the patient`s own immune system to recognize and fight the specific cancer residing within his/her body. This methodology enables targeted cancer treatment which has so far proven to be both potent and remarkably free of adverse side effects. The process is by far more tolerable than alternative treatments currently available such as chemotherapy or surgical intervention, according to researchers.
Merix Technology: Forging New Ground
Merix`s technology is not limited to its dendritic cell platform technology or cancer. " While the deal with Geron does serve to further validate the value of therapeutic cancer vaccine efforts, Merix will continue other pursuits supported by its technology platform as well as other technologies currently being investigated," Dederick says.
" In addition to oncology, Merix has strategically accessed a broad range of immunotherapy technologies with applications in antivirals, autoimmunity and transplantation rejection. For this reason, we have limited the scope of the license with Geron to allow us unfettered use in these areas with the benefit of sharing intellectual property with Geron to further develop the underlying platform."
Merix`s comprehensive expertise in dendritic cell biology has led to the development of novel approaches to treatment for a broad spectrum of immune-mediated diseases. Charles Nicolette, Ph.D., Merix`s Vice President of Research and Development, adds, " Currently, our product pipeline includes potential treatments for such diverse life-threatening diseases as HIV and Lupus, and we are moving toward initial clinical trials in both."
Merix Bioscience, Inc. - a privately held company headquartered in Durham, North Carolina, and with additional operations in Erlangen, Germany - is dedicated to becoming a market leader in the field of immunotherapy
kommentar seitens biotech monthly (berichtet über biotechaktien mit abopreis)
kommentar seitens biotech monthly
biotech monthly hatte im oktober 2003 als erste überhaupt auf die vertraglichen ungereimtheiten zwischen merix und geron berichtet. also noch lange bevor feuerstein von streetcom das thema angefasst hatte
Merix and Geron in technology cross-license
Biotech Monthly first reported the unusual licensing and development agreement between Merix and Geron last October. The article created quite a stir as it conflicted with the research of some investors who purchased shares in a 5M share, $60M stock offering from Geron. The agreement provided no certain path to ownership of TVAX for Geron, which was important as TVAX was responsible for the large increase in Geron`s share price that made the stock offering palatable. If Geron and Merix were not able to agree on a fair price for cross-licensing, the matter was left to binding arbitration. Fortunately for both parties, they were able to agree -- even if that agreement cost Geron far more than some of its shareholders were expecting. Geron gave 5M shares of its stock to Merix (about $43M worth at the time of the deal) to secure an exclusive license to Merix`s dendritic cell therapy platform when used to target Geron`s telomerase antigen. Merix retains the right to use its platform to target a limited, pre-defined set of other antigens, while agreeing not to license that same right to anyone else but Geron. Merix retained full rights to use its platform in whole tumor cell vaccines as well as with other antigens not named in the agreement. From Merix`s point of view, this was a serious win for their private company as they licensed previously abandoned 1st generation technology while retaining full rights to their third-generation whole-tumor RNA approach. The only thing we do not know at the time of publication is whether there are milestone and/or royalty payments to be made to Merix. The release from Geron hinted the 5M shares covered the whole telomerase part of the deal, but we have no confirmation from Merix on this and no details on the arrangement covering the additional specific antigens.
und noch ein weiterer bericht in dieser sache
Hot Product: Merix Bio`s Technology Drew Interest From Two Suitors
By Allan Maurer, LocalTechWire
Editor’s note: BioWatch is a regular feature on Fridays.
MORRISVILLE - Merix Bioscience considered two quite different options before deciding to sell a specific use of its technology to California-based Geron this week.
Clint G. (Skip) Dederick, Jr., chairman and chief executive of Merix tells Local Tech Wire, " Behind the story out there now is the fact that we had two quite different types of options. Both were attractive and it was a tough decision."
Dederick won`t say much about the spurned suitor, other than it is a large multi-national company. " The nice thing is that two different companies were validating our technology and approach. We had to pick one at this time and the board and investors voted for Geron."
The Merix technology helps the body`s immune system recognize and attack tumor cells or viruses. Investors recognize its potential and have poured $54 million into the company, including a record-setting $40 million round in 2001. In February, Merix took a $12 million bridge loan. Durham-based Aurora Funds and Intersouth Partners are backers.
Dederick says that by choosing to sell exclusive rights to Geron for stock valued at $43 million, Merix in some sense creates a competitor. " But there`s only so much money Merix and Geron can raise and it`s not enough to do everything this technology can do," he says.
" Between the two of us, we`re going to find lots of uses for this technology. This deal is not the be-all and end-all of this company."
Merix sold exclusive rights to Geron to use its platform with telomerase, an enzyme found in most cancer cells. Telomerase, which is associated with cancer`s uncontrolled growth, is one of the few defined universal cancer antigens, making it an ideal target for the Merix-Geron therapies being tested on prostrate cancer patients in clinical trials at Duke. An antigen is a substance the immune system recognizes as foreign and attacks.
A therapy effective against telomerase, which is found in most cancer cells and not in most normal ones, is likely to be effective against a broad range of tumors.
Geron wanted to nail down rights to the Merix technology, which it`s using in the Duke prostate cancer trials. Dederick says it still leaves Merix with plenty of things to put in its beakers and test tubes.
For one thing, Dederick points out, " There aren`t that many defined antigens known." He believes researchers will eventually find " a whole series of them" going forward.
The company also sees great potential from its total tumor RNA therapy, which takes RNA from a patient`s cancer and makes cancer specific tags for the immune system to target. One early study, which he says " wasn`t ideal gave us a nice warm feeling because it showed it was extending life. That`s more expensive data than what Geron just paid $43 million in stock for," Dederick says.
Powerful HIV therapy
One Merix project Dederick seems genuinely excited about is the company`s unique approach to treating HIV, the virus that causes AIDS. " We`re the only company I know of coming at it in a personalized approach this way," he said.
The treatment would take genes from a patient`s HIV strains, make multiple copies, then use the Merix technology to tag the patient`s viral proteins so his immune system attacks them.
" I`ve never seen anything this powerful before," says Dederick. " It`s still very early. We haven`t finished pre-clinical work on human blood samples yet."
If it checks out, it could do a lot of good, Dederick says.
Merix has applied for more than $20 million from the National Institute of Health to fund further research of its gene-based AIDS vaccine, which undergoes safety tests later this year.
" We use so-called soft monies -- government funding -- to advance a lot of our projects before putting in lots of dollars," Dederick says.
Dederick says the company plans to pace its growth slowly, adding management and employees gradually. He says the Merix board meets this month and unless they have other ideas, he plans to stay on as CEO of the company
Interview mit okarma von freitag dem 12.3.2004
disclaimers and forward looking statements posted
Thomas Okarma, Ph.D., M.D.
Chief Executive Officer, Director
Dated March 12, 2004
WSR: Good Day from Wall Street and welcome to all our listeners to the Wall Street Reporter. This is Ian Roberts, Senior Analyst with the Wall Street Reporter. Today we have a unique opportunity of taking a look at a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic products for cancer, based on its telomerase technology and cell based therapeutics using its human embryonic stem cell technology. Now the name of the company involved here is Geron Corporation, and Geron Corporation presently trades its shares on the Nasdaq, the ticker symbol GERN. And joining me now on the line to discuss Geron Corporation in light of recent developments and strategy for the 2004 calendar year and beyond is Dr. Thomas Okarma, Ph.D., M.D., President and Chief Executive Officer of Geron Corporation.
Dr. Okarma, good morning to you and welcome to Wall Street Reporter.
DR. OKARMA: Good morning to you Ian, and thank you for having me.
WSR: For those members of our audience, Dr. Okarma, that are not familiar with Geron Corporation, let`s start with an overview and time line of the organization, please.
DR. OKARMA: Well, the company was founded about 10 years ago basically to understand the basic phenomenon of aging. That quickly became focused on mechanisms of cellular senescence or aging and that created the telomerase hypothesis. Telomerase is an enzyme that enables in cancer cells endless replication and in some normal cells such as stem cells in the bloodstream their ability to continue to populate our bloodstream for our entire lives. The focus of the company with that discovery quickly turned to ways to use the telomerase target against cancer. It`s turned out that telomerase is expressed in virtually all human cancers and, as of 2004, it remains the world`s only universal and specific validated cancer target in that it is expressed virtually only in cancer cells and in all of them.
So we now have two specific programs based on the telomerase technology against cancer. The one that is most advanced that is in the clinic is a telomerase vaccine. This is an attempt to turn the cancer patient`s immune system on against telomerase enabling the patient`s T cells, or T lymphocytes, to attack the tumor cell and destroy it. We have been exploring alternate methods of turning the cancer patient`s immune system on against telomerase for several years and the one that is most attractive to us is the platform developed by Merix Bioscience in North Carolina with whom we have just this week announced a major co-exclusive licensing agreement giving Geron exclusive rights to the entire spectrum of Merix technology for telomerase and co-exclusive rights with Merix for their entire platform dealing with other defined antigens like telomerase that we might want to employ. So this agreement enables us to have ownership of the program going forward.
Now the enthusiasm that we have is based upon the data that we`re generating at Duke in a Phase I/II study in prostate cancer and some of the data has been reported over the past year and there will be an update in the next couple of weeks which should include a full wrap-up of all the patients in the study. What I can tell you now generally is that, first, virtually all of the subjects with advanced cancer have responded immunologically to the vaccine, meaning they have generated in their bloodstream telomerase specific T cells which are active against their cancers. The manifestation of the activity is twofold. First, we`re showing that these cells are able to clear the patient`s bloodstream of metastasizing prostate cancer cells which is of course one of the objectives of the exercise. And secondly, and perhaps more importantly, we`re demonstrating that the T cells slow down the rate of progression of the disease as measured by the PSA velocity, which is the rate at which the PSA test rises. That is a marker of spread of the cancer in the patient`s body. We are able to do all of this without any adverse reactions whatsoever. So for us these data confirm our general hypothesis about telomerase, which is, if you accurately and selectively target it, you get selective killing of cancer cells. So this deal enables us to take this platform forward and perform advanced studies in prostate cancer and other tumors, as well as to access other inventions in the basket of Merix that have some potential to improve the potency of the current vaccine, reduce its costs and as well as to increase its duration. So we`re very excited about what we`ve been able to generate with Merix and this deal which gives Geron freedom to operate to continue to develop it.
WSR: Certainly tremendous news. In looking at that, your advancement in the oncology programs based on this news, what can you tell us in terms of the maturation of the program, what is the next step here that we should keep in mind for the oncology programs at Geron Corporation?
DR. OKARMA: Well, as I mentioned, we will certainly be advancing the ball on the vaccine, both extending the period of vaccinations, extending the types of cancers that we test this approach on, with a view toward a corporate filed IND hopefully in the coming year. We will continue to do the work in academic centers until we have finalized the format of the vaccine at which time the company, we, will take over the IND filing.
On the drug side of our cancer portfolio is another program that is equally exciting. This is a drug that inhibits the enzyme telomerase, and like the vaccine work where we`re demonstrating that the T cells that the vaccine generates are active against many different kinds of cancers, we`re showing the same thing with our drug – that virtually all of the major cancers of man are susceptible to killing by this telomerase inhibitor drug. And also like the vaccine, we find that the telomerase inhibitor drug does not affect normal cells at therapeutic doses. So this is truly a so-called magic bullet that selectively kills tumor cells without harming normal cells. Now this is a drug that has been almost 10 years in development. It`s a drug that we have built from the ground up based upon our molecular understanding of the telomerase target. It is an oligonucleotide, a 13 mer drug that we have developed with our own proprietary chemistry that even though it`s a, has a molecular weight of about four thousand, the drug acts almost as if it were a true small molecule, in terms of bioavailability, penetrance into tissue spaces and its pharmacokinetic profile. We believe we`ll be able to administer this drug with a single once a week IV bolus injection, making it convenient for both physicians and hospitals as well as for patients. The drug is extremely potent. It inhibits telomerase at what are called picomolar concentrations - that`s a very small number of drug molecules required to shut the enzyme down in a tumor cell. So while we know that the market and the, the world has been waiting for us to move this drug into the clinical environment, we feel that the wait will be worth it. So we are on track now with our IND enabling studies for an IND submission either at the very end of this year, or at the latest at the beginning of next year. We have multiple manufacturing contracts in place and frankly, if there is a delay beyond this year, it`s because of manufacturing issues, the date of delivery to us of GMP material which is required to do the IND enabling studies. But we are extremely excited by the behavior of this drug in animal studies, where in 5 out of 5 different human cancers in animals we show dramatic evidence of efficacy and good evidence of safety, and in addition, a wide spectrum of tumors in vitro that are susceptible to being killed by this compound. So, in ‘05, Geron`s oncology program will have matured into two clinical programs - the vaccine in hopefully multiple medical centers and the drug in a couple of medical centers as well. And our first clinical target for the drug we believe will be hematologic tumors because that enables us to not only determine the safety profile of the compound, but it also enables us to demonstrate that the drug is actually inhibiting telomerase in the cancer cells because for hematologic malignancies we can obtain the cancer cells by a simple blood draw. So, by no means is the drug limited to leukemias and lymphomas, but that will probably be the first clinical target that we`ll use the drug against to learn as much as we can about it, in the same way that we chose prostate cancer as the first tumor type to learn about the cancer vaccine.
WSR: Certainly tremendous news in displaying the maturation of the oncology programs, are making tremendous strides there, and as we look also, the company does have a focus in regenerative medicine, I understand through work with your human embryonic stem cell platform. Can you give us a sense there of the updates and the maturation of that focus on embryonic stem cells?
DR. OKARMA: Sure. And I should start by making the comment that the telomerase core competence of Geron actually led directly into the embryonic stem cell field as well. The reason for that is early in embryonic development all of the cells in the developing embryo are telomerase positive, because that`s the time that nature is creating the human body and these cells must be able to divide indefinitely without becoming senescent. So we thought that if we could derive the human equivalent of the mouse embryonic stem cell which had been around for 20 years, it would be telomerase positive and if so, we would have an indefinitely self-renewing source for the manufacturing of replacement cells for literally every organ in the body. And that expectation in fact has been confirmed. So we have now 9 different embryonic stem cell lines of human origin, they are telomerase positive and we`ve published on the fact that they are able to divide indefinitely in culture, so they are truly a self-renewing source to manufacture replacement cells from. We`ve now learned how to make 8 different therapeutic cell types from our undifferentiated stem cell lines, ranging from glial cells for spinal cord injury which will be our first clinical application to cells for Parkinson`s Disease, for diabetes, for heart failure, for osteoporosis, arthritis and so on. Our most advanced cell types are the glial cell and the cardiomyocyte which I`ll describe in a little more detail.
What we`ve shown now in our animal studies in models of acute spinal cord injury is that these glial cells that we make from embryonic stem cells when injected into the animal`s injured cord not only provide functional recovery for the animal, but when the animal is sacrificed and we examine histologically the area of the injury, we find the human glial cells have restored the functional integrity of the injury. So the animal`s neurons are re-myelinated or insulated by the human glial cells and that is the reason why we see such dramatic functional recovery. We transform the animal from one that has a permanent paralysis of its lower extremity and tail to animals that are able to bear weight on all four limbs and hold their tail erect. So we expect to be able to file our IND on this glial cell sometime in ‘05, based upon our work plan and the data that we`ve generated now and has been repeated on, with outside collaborators who are world experts in spinal cord injury. Now this would be the first demonstration of what human embryonic stem cells can do generally, which is something that is beyond the realm of pharmacology or drug approaches, namely the re-engineering of tissue that has been permanently damaged by a chronic disease or an injury.
Our work with heart muscle cells or cardiomyocytes is confirming this general notion. This is work now done in collaboration with us at two academic institutions in this country where we`re showing that these cardiomyocytes when injected into the hearts of animals that are given a heart attack 4 weeks later are able to engraft into the animal`s heart, restore its normal histology and restore functional output of the animal. So just like the spinal cord injury example, these heart muscle cells are restoring functional integrity of the heart muscle that has been permanently damaged by an experimental heart attack.
Our work with the islet cells are progressing well in animals. Our work with bone forming, excuse me, bone, blood forming cells is progressing well in animals, as is our work with bone forming cells. But the first two cells to enter the clinical environment over the next 12 to 24 months we think will be glial cells for spinal cord injury and heart muscle cells for heart failure. And this is, of course, many years before most people ever thought that cells derived from human embryonic stem cells would be available for clinical work.
Two of our lines are now qualified for use in humans, having passed all of the tests the agency has asked us to subject them to, to demonstrate that they are free of human or cow or pig or mouse viruses, so we can generate the glial and heart muscle cell from these qualified lines. We`ve learned how to scalably produce these cell types and that`s an important point for the field generally. These are cells that can be manufactured with much of the same efficiency and precision as a biological drug or a monoclonal antibody. They are very different from so-called adult stem cells which generally have to be extracted from individuals and used for a single dose application. Cells derived from human embryonic stem cells are made in multi dose production lots just the way you`d make a pill or a biological. So our mantra here on the regenerative medicine side of our country, company is that living cells will become tomorrow`s pills and I think we are 12 to 24 months away from really realizing that.
WSR: Certainly tremendous promise on that side of the business and looking at the company from a standpoint of operational activities and finances, what can you tell us about the balance sheet there, and does the company have the finances in place to accomplish a lot of the mission that you`ve set out?
DR. OKARMA: Well, we were able to raise nearly $80 Million last year in two offerings and so we began this year with over $100 Million in the bank. We also did the hard things over the past year, reducing the workforce to focus on people who are development scientists as opposed to research scientists and we are now beginning to hire more manufacturing types, particularly for the glial cell program in spinal cord injury. So we do have the resources and the appropriate mix of employees to segue the company from a research driven organization to one that is product development oriented. We have multiple manufacturing contracts in place for the drug. We will be manufacturing the glial cells for the oligodendrocyte for the spinal cord trial. The vaccine is actually made within the medical center environment. We were able to convert all of our debentures last year, so our balance sheet is in fact now debt free. So we do have the resources, both economic and human, to make good on our promises now of segueing the company from a research mode into a clinical development one.
WSR: Outstanding. And in closing, final words for our audience here, Dr. Okarma, the value proposition in Geron Corporation, what are the reasons that should be paramount in our understanding of that value proposition, the reasons we should continue to track and follow Geron Corporation in the near term and beyond?
DR. OKARMA: Well, first on the cancer side of the company. Our core competence is telomerase which remains the world`s only validated, universal and specific cancer target. And all of our data, in fact all of the data even generated by others, is supportive of that notion. So our approach in vaccination and in telomerase inhibitor drugs, are both safe and should be effective broadly against cancer, used alone or in combination with existing chemotherapy approaches. So it is a new target and we have two dramatic approaches to leverage that target for breakthroughs in cancer treatment.
On the stem cell side, this has been a platform that has been dreamed of by people like me who have been in cell therapy for over 15 years, in that the technology is scalable, the specs of the products we make from them are narrow and reproducible and what the cells appear to be doing in animals is a new paradigm in treating chronic disease. As you know, drugs today merely treat the symptoms of chronic disease; these cells promise to fundamentally change the tissue permanently that has been damaged by the chronic process and as such that will change the practice of medicine
WSR: Certainly exciting prospects and a bright horizon for Geron Corporation. I`d like to thank my guest, Dr. Thomas Okarma, M.D., Ph.D., the President and Chief Executive Officer for taking the time to update our office, our audience on the developments there at Geron Corporation and I certainly wish you, Dr. Okarma, the best of continued success there.
DR. OKARMA: Thank you, Ian.
WSR: Thank you again. This has been Ian Roberts, Senior Analyst with the Wall Street Reporter. Our featured guest today has been Dr. Thomas Okarma, Ph.D., M.D., President and Chief Executive Officer of Geron Corporation. Geron Corporation is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic products for cancer based on its telomerase technology and cell based therapeutics using its human embryonic stem cell technology. The company, Geron Corporation, trades its shares on the Nasdaq, the ticker symbol Gern
und hier einige wichtigen passagen aus dem interview aber es gibt auch noch andere
Now the enthusiasm that we have is based upon the data that we`re generating at Duke in a Phase I/II study in prostate cancer and some of the data has been reported over the past year and there will bean update in the next couple of weeks which should include a full wrap-up of all the patients in the study.
Es gibt ein Update in den folgenden Wochen(3/27 AACR), welches volle Aufräumarbeiten aller Patienten in der Studie umfassen sollte!!!!!!!!!!!!!
Na endlich !!!
Our work with the islet cells are progressing well in animals. Our work with bone forming, excuse me, bone, blood forming cells is progressing well in animals, as is our work with bone forming cells
. But the first two cells to enter the clinical environment over the next 12 to 24 months we think will be glial cells for spinal cord injury ]and heart muscle cells for heart failure . And this is, of course, many years before most people ever thought that cells derived from human embryonic stem cells would be available for clinical work
insgesamt gefällt mir das alles sehr gut
und besonders das versprochene update aller patienten der klinischen phase 1/2.