From: Savant | 12/10/2012 11:50:13 AM | | | | Geron presents positive results from Phase 2 study of imetelstat in essential thrombocythemia at the American Society of Hematology Annual Meeting Co announced positive clinical results from the Phase 2 trial of imetelstat, the company's first-in-class telomerase inhibitor, in patients with essential thrombocythemia (ET). The data, which showed rapid and durable hematologic and molecular responses in patients treated with imetelstat, were presented Sunday evening in an oral session at the 54th Annual Meeting of the American Society of Hematology in Atlanta, GA. The results from the first 14 patients enrolled in the ET study were reported. All were refractory to or intolerant of conventional therapies (hydroxyurea, anagrelide and/or interferon-alpha). Platelet counts were reduced in all patients (a 100% hematologic response rate) and normalized in 13 out of 14 patients (a 92.9% complete response rate). The allelic burden of the JAK2 V617F gene mutation decreased over time in the seven patients who had such a mutation, with substantial reductions that qualified as partial molecular responses achieved in six out of seven (85.7%) patients within three to six months of treatment with imetelstat. In the study, imetelstat was generally well tolerated. The majority of the non- hematologic adverse events were mild-to-moderate in severity, the most frequent being gastrointestinal events. |
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From: tktrimbath | 12/31/2012 10:59:23 PM | | | | My End of Year Review of GERN
INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.
Geron GERN (market cap $0.184B) Geron is a leading edge biotech specializing in critical treatments for the big medical issues: organ replacement and repair, cancer treatment, and such via telomerase, stem cells, nuclear transfers, and some novel chemistry. I liked their approach. They have been bold enough to pursue some of the most powerful biological technologies that many talk about, but few act upon. Despite their boldness, they have been conservative and cogniscent of public perception and federal regulations. Such medical advances can create great companies, but are high risk, cost more, and require longer clinical trials. If successful, their technological advantages may be hard to replicate or compete against.
Sadly, 2012 seemed to be the year of cancelled clinical trials. Geron finally got out of the lab and into the patient population, but for a variety of reasons they were not as successful as they, or I, had hoped. Diversification is important in risky ventures, and fortunately Geron has had more than only technology to pursue. Unfortunately, the list seems dramatically reduced. Good news is still possible, and there has been some, but the stock price attests that the news hasn't been significant enough within the investment community.
Failure in one set of trials does not change the odds of the other trials. I must remind myself of that.
DISCLOSURE LTBH since 1999 and continuing to hold. I won't buy more because 1) I have no discretionary funds (ask my mortgage company) and because I may have enough stock if they succeed (in which case I can pay off my mortgage company). Unfortunately, I may have to sell if I can't find a job or sell my house. (I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com) |
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To: tktrimbath who wrote (3354) | 1/1/2013 1:35:41 AM | From: mcbio | | | I had pretty much left GERN for dead. But their data with imetelstat against essential thrombocythemia ( ir.geron.com ) has me rethinking. Per recent CC, they have almost 3 years of cash and they believe imetelstat works in diseases with short telomeres (this may include myelofibrosis, which they are expanding testing into). |
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From: Savant | 1/7/2013 10:40:34 AM | | | | BioTime Signs Definitive Agreement With Geron Regarding Stem Cell Assets
Investor Commits to $10 Million Financing
ALAMEDA, Calif., Jan 07, 2013 (BUSINESS WIRE) -- BioTime, Inc. (nyse mkt:BTX) and its recently formed subsidiary BioTime Acquisition Corporation (BAC) jointly announced today that they have entered into a definitive Asset Contribution Agreement with Geron Corporation (GERN) to acquire the intellectual property, including patents and patent applications, and other assets related to Geron's human embryonic stem (hES) cell programs consistent with the financial terms outlined in the letter of intent announced on November 15, 2012.
Under the definitive agreement, Geron will contribute to BAC intellectual property, certain cell lines and other assets, including the Phase 1 clinical trial of hES cell-derived oligodendrocytes in patients with acute spinal cord injury, and Geron's autologous cellular immunotherapy program. BioTime will contribute to BAC $5 million in cash, 8,902,077 BioTime common shares to be held by BAC, five-year warrants to purchase 8,000,000 common shares of BioTime at a price of $5.00 per share ("BioTime Warrants"), rights to use certain clinical grade hES cell lines, a sublicense to use certain patents for stem cell differentiation technology, and minority stakes in two of BioTime's subsidiaries, OrthoCyte Corporation and Cell Cure Neurosciences Ltd. BAC will also pay to Geron royalties on the sale of products that are commercialized, if any, in reliance upon Geron patents contributed or licensed to BAC. A private investor has also agreed to provide an equity investment of $5 million in BAC and a $5 million equity investment in BioTime in conjunction with the transaction.
Geron pioneered the field of regenerative medicine in the mid-1990s by organizing the first effort to isolate human embryonic stem (hES) cells. hES cells are early-stage stem cells that are capable of becoming all of the cell types in the human body, and therefore are widely recognized as a means of manufacturing cells that are potentially useful in regenerating tissue function for a wide array of degenerative diseases. Currently, Geron's hESC patent portfolio includes over 400 patents and patent applications that will be transferred or sublicensed to BAC. Geron obtained the first approval from the Food and Drug Administration for human clinical trials of a product manufactured from hES cells.
Geron's former hES cell programs included oligodendrocyte progenitor cells for central nervous system disorders, cardiomyocytes for heart disease, pancreatic islet cells for diabetes, dendritic cells as an immunotherapy vehicle, and chondrocytes for cartilage repair. BAC may pursue the development of therapeutic products from some or all of these cell types, depending upon a number of factors, including the expected cost of development, sufficiency of financing, the state of development of the technology acquired, regulatory considerations, anticipated market size, and competition from other companies in the applicable fields. BAC may also seek to develop other therapeutic products, taking into account the same or other applicable considerations.
"Our consistent goal at BioTime has been to consolidate the pluripotent stem cell technology platform," stated Michael West, Ph.D., Chief Executive Officer of BioTime, Inc. "With this contribution of assets, the combined intellectual property estate in the BioTime family of companies will be among the strongest in the field of Regenerative Medicine; establishing our leadership in the industry and advancing product development."
"We are excited about our approach toward consolidating the most important technologies in Regenerative Medicine," said Thomas Okarma, M.D., Ph.D., president and CEO of BAC. "Regenerative Medicine holds great promise for patients and now, with our significant collection of world class stem cell technologies, IP, and experienced management, we are positioned to help realize that promise."
Closing of the transactions under the definitive agreement is subject to certain negotiated closing conditions, including the registration of the BAC Series A common stock, the BioTime common shares contributed to BAC, and the BioTime Warrants under the Securities Act of 1933, as amended, and certain approvals by BioTime shareholders. The transaction is expected to close no later than September 30, 2013.
Upon closing of the transaction, Geron will receive BAC Series A common stock, and BioTime and the private investor will receive BAC Series B common stock in the transaction. The Series A and Series B common stock will be identical, except that BAC will be entitled to make certain distributions or pay dividends on its Series A common stock without making a distribution or paying a dividend on its Series B common stock.
Following the closing of the transaction, Geron will distribute on a pro rata basis to its stockholders the shares of BAC Series A common stock received in the transaction. Following that distribution by Geron, BAC will distribute on a pro rata basis to the holders of those shares the BioTime Warrants. The Series B common stock will be convertible into Series A common stock following the distribution of the BioTime Warrants.
Following these distributions, BioTime will own approximately 71.6%, Geron stockholders will own approximately 21.4%, and the private investor will own approximately 7.0%, of the outstanding BAC common stock. BioTime and the private investor will also receive warrants to purchase additional shares of BAC Series B common stock that would enable them to increase their collective ownership in BAC by approximately 2.2%, which would reduce the Geron stockholders' ownership in BAC to approximately 19.2%.
BAC plans to seek to list its Series A common stock, and BioTime intends to seek to list the BioTime Warrants, on a national securities exchange.
In anticipation of use by BAC, BioTime is entering into a three-year lease of an office and research facility in Menlo Park, Calif.
In a separate and related transaction, BioTime and BAC have each entered into Stock and Warrant Purchase Agreements with a private investor to provide each company with $5 million in equity financing. Under the terms of the BioTime agreement, the investor will invest $5 million in BioTime by purchasing an aggregate of 1,350,000 BioTime common shares at a purchase price of approximately $3.70 per share and warrants to purchase 650,000 additional BioTime common shares with an exercise price of $5.00 per share and a three year term. The shares and warrants will be sold to the investor in two tranches. In the first tranche, the investor will purchase 540,000 BioTime common shares and warrants to purchase approximately 260,000 BioTime common shares for $2 million subject to the conditions of the Stock and Warrant Purchase Agreement. The second BioTime investment tranche of $3 million will be funded in conjunction with the closing of the stem cell asset transaction with Geron. Closing of the second tranche of the share and warrant purchase is subject to certain additional conditions; these conditions include the closing of the stem cell asset transaction. This $5 million investment will be used to fund BioTime's $5 million cash contribution to BAC.
Under the terms of its Stock Purchase Agreement with BAC, the investor will contribute $5 million in cash to BAC in exchange for 2,136,000 shares of BAC Series B common stock that, upon issuance, will represent approximately 7% of the BAC common stock outstanding at the closing, plus warrants to purchase approximately 350,000 additional shares of BAC Series B common stock at an exercise price of $5.00 per share, with a three year term. Closing of the financing in BAC will occur in conjunction with the closing of the stem cell asset transaction with Geron, and is subject to certain conditions, including the closing of the stem cell asset transaction.
Kaye Scholer LLP and Thompson, Welch, Soroko & Gilbert LLP are acting as legal counsel to BioTime in connection with the transaction.
Additional Information and Where to Find It
All parties desiring details regarding the transaction are urged to review the definitive agreement when it is available on the Securities and Exchange Commission's (the "SEC's") website at sec.gov. In connection with the proposed transaction, BioTime will file with the SEC a proxy statement, and plans to file with the SEC other documents regarding the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THE PROXY STATEMENT AND OTHER FILED DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Shareholders will be able to obtain a free-of-charge copy of the proxy statement and other relevant documents (when available) filed with the SEC from the SEC's website at sec.gov. Shareholders will also be able to obtain a free-of-charge copy of the proxy statement and other relevant documents (when available) by directing a request by mail or email to BioTime's Chief Financial Officer at 1301 Harbor Bay Parkway, Alameda, California 94502 or pgarcia@biotimemail.com. BioTime and Geron and certain of their respective directors and executive officers may, under the rules of the SEC, be deemed to be "participants" in the solicitation of proxies from shareholders of BioTime in favor of the share issuance and other proposals in connection with the proposed transaction. Information regarding BioTime's directors and executive officers is contained in BioTime's definitive proxy statement filed with the SEC on April 30, 2012. Information about Geron's directors and executive officers is set forth in Geron's proxy statement for its 2012 Annual Meeting of Stockholders, which was filed with the SEC on April 24, 2012. The proxy statement and other relevant documents (when available) filed with the SEC are available free of charge with the SEC are available free of charge at the SEC's website at sec.gov, and from Geron by contacting Investor Relations by mail at Geron Corporation, 149 Commonwealth Drive, Suite 2070, Menlo Park, California 94025, Attn: Investor Relations Department, or by going to Geron's Investor Relations page on its corporate website at geron.com. Additional information regarding the interests of such potential participants will be included in the proxy statement and the other relevant documents filed with the SEC (when available).
This communication is for informational purposes only and does not constitute an offer to sell any BAC common stock or warrants or any BioTime common shares or warrants or a solicitation of any vote or approval, nor is it a substitute for a prospectus that may be included in a registration statement that may be filed by BAC or BioTime with the SEC under the Securities Act with respect to the proposed transaction, or a proxy statement that will be provided to BioTime shareholders. BioTime and BAC are not offering to sell, or soliciting an offer to buy, any securities in any state where the offer or sale is not permitted.
About BioTime, Inc.
BioTime, headquartered in Alameda, Calif., is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem cells and regenerative medicine, including a wide array of proprietary PureStem(TM) cell lines, HyStem(R) hydrogels, culture media, and differentiation kits. BioTime is developing Renevia(TM) (formerly known as HyStem(R)-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx(TM) currently being developed for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's subsidiary LifeMap Sciences, Inc., markets GeneCards(R), the leading human gene database, and has developed an integrated database suite to complement GeneCards(R) that includes the LifeMap Discovery(TM) database of embryonic development, stem cell research and regenerative medicine, and MalaCards, the human disease database. LifeMap is also marketing BioTime research products. BioTime's lead product, Hextend(R), is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc., and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements. Additional information about BioTime can be found on the web at biotimeinc.com.
About BioTime Acquisition Corporation
BioTime Acquisition Corporation is a newly formed wholly owned subsidiary of BioTime, Inc., through which BioTime plans to pursue opportunities and acquire assets and businesses in the fields of stem cells and regenerative medicine.
BioTime Forward-Looking Statements
Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Statements in this press release regarding BioTime or BAC's plans, expectations or timing relating to BAC's acquisition of the stem cell assets and related transactions are forward-looking statements and these statements involve risks and uncertainties, including, without limitation, the ability of the parties to close the transaction in a timely manner or at all, the possibility that conditions to closing of the proposed transaction, including the approval of BioTime's shareholders, and the effectiveness of registration statements to be filed by BioTime and BAC with the SEC, may not be satisfied, as well as risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in BioTime's periodic reports filed with the SEC under the heading "Risk Factors" and and other filings that BioTime or BAC may make with the SEC. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change. Except as required by law, BioTime and BAC each disclaims any intent or obligation to update these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: phx.corporate-ir.net.
SOURCE: BioTime, Inc.
BioTime, Inc. Peter Garcia, 510-521-3390, ext. 367 Chief Financial Officer pgarcia@biotimemail.com or Judith Segall, 510-521-3390, ext. 301 jsegall@biotimemail.com |
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From: Savant | 2/1/2013 1:52:06 AM | | | | RT... LifeMap Sciences, a Subsidiary of BioTime, Announces Publication of Research Report Describing Non-Redundant Compendium of Human Non-Coding RNA Authored by GeneCards(R) Scientists
Report shows the existence of a^ 1/480,000 human non-redundant non-coding RNAs covering 71% of the human genome, slightly less than the ENCODE prediction of 80%
ALAMEDA, Calif., Jan 30, 2013 (BUSINESS WIRE) -- LifeMap Sciences, Inc., a subsidiary of BioTime, Inc. (nyse mkt:BTX), announced today the publication of a paper authored by a research group under the supervision of Prof. Doron Lancet from the Department of Molecular Genetics at the Weizmann Institute of Science describing the analysis and display of a non-redundant compendium of human non-coding RNA genes, which was made available as part of GeneCards(R) Version 3.09, released November 18, 2012. LifeMap Sciences holds the exclusive worldwide license to market GeneCards(R) from Yeda Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science.
Non-coding RNA (ncRNA) genes are increasingly acknowledged for their importance in the human genome, and are implicated in various disease processes. Therefore they are of interest to many academic and industry researchers in various biomedical fields, and to biotechnology and pharmaceutical companies engaged in discovery and development of diagnostic and therapeutic products. The ENCODE project Click for Detail, launched in 2003 has recently predicted that ~80% of all genomic territories are transcribed in one fashion or another. In the GeneCards(R) publication, in the journal Bioinformatics Click for Detail, the scientists leveraged the effective platform of GeneCards(R) to unify all ncRNA gene entries obtained from 15 different primary data sources. Overlapping entries were clustered to unified locations based on an algorithm employing genomic coordinates, resulting in a a^ 1/45-fold increase, to a total of a^ 1/480,000 human non-redundant ncRNAs, belonging to 14 classes. The total genome territory covered is 71% of the human genome, slightly less than the ENCODE prediction. This difference may be due to dataset input and computation discrepancies or may represent ncRNA genes still awaiting identification and characterization.
GeneCards(R) is a comprehensive online database that provides concise genomic information on all known and predicted human genes. With over 12 million page visits per year from hundreds of thousands of unique users worldwide, GeneCards(R) is accessed by professionals in academia, research hospitals, patent offices, and leading biotech and pharma companies. GeneCards(R) was developed, and is continuously enhanced by ongoing research, by the bioinformatics team at the Department of Molecular Genetics at the Weizmann Institute of Science in Israel, with principal investigator Professor Doron Lancet, head of the Crown Human Genome Center, and team leader Marilyn Safran.
"It is wonderful to see how GeneCards(R) allowed us to overcome the great obstacles of grand unification of ncRNA genes. This allows scientists to make discoveries on biological and disease-related roles for genes belonging to this newly open vista of the human genome," said Professor Doron Lancet, Ph.D., The Ralph D. and Lois R. Silver Professor of Human Genomics, at the Weizmann Institute of Science.
"The addition of detailed annotated ncRNAs information, while providing the big picture on ncRNAs is a significant addition to GeneCards(R)," stated Yaron Guan-Golan, Head of Marketing at LifeMap Sciences. "We have already seen substantial interest from companies and academic users to access this new information for their research and product discovery efforts. We believe that this new information, and the synergies between GeneCards(R), MalaCards, and LifeMap Discovery(TM) will significantly enhance basic research, and contribute greatly to the discovery and development of novel diagnostic and therapeutic products and technologies."
About LifeMap Sciences, Inc. |
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From: Savant | 2/1/2013 1:53:02 AM | | | | RT...BioTime's Subsidiary OncoCyte Corporation Provides an Update on the Development of the Novel Pan-Cancer Diagnostic Product PanC-Dx(TM)
Multi-center clinical study of a blood-based diagnostic test for the early detection of cancer planned for 2013
ALAMEDA, Calif., Jan 31, 2013 (BUSINESS WIRE) -- BioTime, Inc. (nyse mkt:BTX) and BioTime's subsidiary OncoCyte Corporation provided an update on the progress of development of PanC-Dx(TM), a novel blood-based diagnostic test utilizing molecular markers discovered at BioTime and OncoCyte designed to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon. By facilitating early, non-invasive cancer detection, PanC-Dx(TM) could lead to more successful therapeutic outcomes through earlier diagnosis and treatment. This diagnostic test could also reduce the cost of cancer monitoring and increase the availability of affordable cancer screening worldwide. OncoCyte first announced the development of PanC-Dx(TM) during December 2011 and last provided a progress update in March 2012. In addition to this update, OncoCyte intends to release additional information regarding the progress of PanC-Dx(TM) development throughout 2013.
OncoCyte's plans for 2013 include the initiation of a clinical study focused on breast cancer screening at a group of leading cancer research institutions. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies in preparation for the initiation of the clinical study and is currently working with a select group of cancer researchers to design the trial and select the study sites. If its laboratory findings are validated in clinical trials, PanC-Dx(TM) may be used as a simple, routine blood test that could be performed in women of any age at any desired frequency to detect breast cancer with as much if not better accuracy and with less cost than a conventional mammogram.
OncoCyte has achieved several key advances in the past year, including:
-- Completion of the development and characterization of over 50 proprietary, patent pending, monoclonal antibodies targeting 7 novel cancer antigens. OncoCyte's findings show a significant elevation of these antigens in the blood of cancer patients when compared to healthy control patients;
-- Initiation of validation studies of ELISA assays in order to demonstrate high-sensitivity detection of target antigens using proprietary monoclonal antibodies;
-- Completion of large-scale manufacturing of 11 proprietary monoclonal antibodies;
-- Initiation of prototype development for a second detection format (solid phase ELISA point of care testing) through a collaborative development agreement; and
-- Initiation of clinical trial protocol design analysis in consultation with key opinion leaders and outside diagnostic experts.
Key goals for 2013 will be:
-- Completion of validation of our proprietary ELISAs in our patient sample dataset;
-- Formalization of additional relationships with key opinion leaders at major medical institutions;
-- Institutional review board (IRB) approval and initiation of a large, prospective multicenter patient study at leading breast cancer institutions;
-- Presentation of key findings at major oncology-related scientific conferences; and
-- Submission of manuscripts to peer-reviewed scientific journals for publication.
Based on large unmet need, market size, and data generated thus far from patient sera screening, OncoCyte is initially focusing its efforts on biomarkers associated with breast cancer. The apparent high correlation of certain combinations of biomarkers in breast cancer has made this indication an attractive initial target. If clinical trials are successful, OncoCyte intends to launch PanC-Dx(TM) as an in vitro diagnostic (IVD) in Europe, potentially commencing in 2014, before seeking FDA approval required to market PanC-Dx(TM) in the United States. Some CLIA-certified clinical laboratories may choose to offer PanC-Dx(TM) on a limited basis prior to EU and FDA approval.
"OncoCyte has made substantial progress in the development of PanC-Dx(TM) since our last update in March of 2012," said Joseph Wagner, Ph.D., CEO of OncoCyte. "Most importantly, we have developed and characterized a large repertoire of proprietary monoclonal antibodies to a set of breast cancer-related protein markers that we have identified and validated over the last few years. OncoCyte has filed patent applications on these novel, unique markers that we believe are early indicators of the presence of breast cancer. We have manufactured substantial quantities of a subset of these proprietary antibodies that show the greatest promise and we are currently assembling ELISA-format assays. Once we have completed the validation of these assays and our clinical trial design work, we intend on initiating a large, multicenter clinical trial later this year."
"There is a great need for rapidly deployed, effective screens to identify a wide array of human cancers at their earliest stages. A blood-based test with superior accuracy designed to detect breast cancer at early stages would have a substantial impact in the women's health community," said Dr. Andrew von Eschenbach, former Director of the U.S. National Cancer Institute and former U.S. Food and Drug Administration Commissioner. Dr. von Eschenbach, a specialist in urological cancer, is a member of the BioTime and OncoCyte boards of directors. "Early detection remains our current best hope for achieving cures. Therefore, the development of more accurate diagnostics and screens for all major cancer types should be a national priority."
Michael West, Ph.D., CEO of BioTime added, "We are pleased with the deep insights into cancer biology generated by this discovery effort. These discoveries were the direct outcome of the broad regenerative medicine and bioinformatics platform that has been built at the BioTime family of companies and demonstrates the breadth of potential applications of our technology. Besides leading to novel diagnostics, these new insights may point the way to future therapeutic strategies to target and destroy cancer cells while leaving normal tissue intact."
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem cells and regenerative medicine, including a wide array of proprietary PureStem(TM) cell lines, HyStem(R) hydrogels, culture media, and differentiation kits. BioTime is developing Renevia(TM) (formerly known as HyStem(R)-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx(TM) currently being developed for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's subsidiary LifeMap Sciences, Inc. markets GeneCards(R), the leading human gene database, as part of an integrated database suite that also includes the LifeMap Discovery(TM) database of embryonic development, stem cell research and regenerative medicine, and MalaCards, the human disease database. LifeMap Sciences also markets BioTime research products and PanDaTox, an innovative, recently developed, searchable database that can aid in the discovery of new antibiotics and biotechnologically beneficial products. BioTime Acquisition Corporation is a new subsidiary being used to acquire the stem cell assets of Geron Corporation, including patents and other intellectual property, biological materials, reagents and equipment for the development of new therapeutic products for regenerative medicine. BioTime's lead product, Hextend(R), is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements. Additional information about BioTime can be found on the web at biotimeinc.com.
About OncoCyte Corporation
OncoCyte Corporation is a majority-owned subsidiary of BioTime, Inc. OncoCyte's mission is to develop novel products for the diagnosis and treatment of cancer in order to improve both the quality and length of life of cancer patients. OncoCyte's molecular diagnostics division is developing products for earlier detection of a variety of cancers. In addition to its diagnostic product line, OncoCyte is developing cellular therapies to treat cancer based on the unique biology of vascular precursor cells. The goal of OncoCyte's therapeutic research efforts is to derive vascular cells that can be engineered to deliver a toxic payload to the developing blood vessels of a malignant tumor to destroy the tumor without killing nearby normal tissues in the body. Additional information on OncoCyte can be found on the web at oncocyte.com.
Forward-Looking Statements
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: phx.corporate-ir.net
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SOURCE: BioTime, Inc.
BioTime, Inc. Peter Garcia, 510-521-3390, ext 367 Chief Financial Officer pgarcia@biotimemail.com Judith Segall, 510-521-3390, ext 301 jsegall@biotimemail.com |
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From: Savant | 3/12/2013 12:21:28 PM | | | | RT.. BioTime Appoints Stephen C. Farrell to Board of Directors
ALAMEDA, Calif., Mar 12, 2013 (BUSINESS WIRE) -- BioTime, Inc. (nyse mkt:BTX) today announced that Stephen C. Farrell has been appointed to its Board of Directors.
"We are pleased to welcome an experienced executive of Steve's caliber to BioTime's board," said Alfred D. Kingsley, Chairman of the Board of BioTime. "Steve adds critical and highly relevant experience as a successful leader and director of healthcare companies during periods of rapid growth. His operational and financial experience and his strategic vision will be valuable additions to our board during an exciting period of growth for BioTime."
"BioTime's development and progress toward the acquisition of novel technologies in the stem cell space over the past year, along with its recent successful financings, have further established it as a leader in regenerative medicine," said Mr. Farrell. "I am honored to join the BioTime Board of Directors during such an important time in the Company's growth, and look forward to contributing to the development of these new technologies, which have the potential to significantly improve the health and quality of life of patients around the world."
Mr. Farrell currently serves as Chief Executive Officer and Director of Convey Health Solutions (formerly known as NationsHealth, Inc.), a healthcare business process outsourcing company headquartered in Sunrise, Florida. Convey Health Solutions utilizes both technology and staff to manage end-to-end insurance processes for business clients. Previously, he served as President of PolyMedica Corporation, a publicly traded provider of diabetes supplies and related services that was acquired in 2007 by Medco Health Solutions in a transaction valued at $1.5 billion. During his eight year tenure at PolyMedica, Mr. Farrell served as its President, Chief Operating Officer, Chief Financial Officer, Chief Compliance Officer, and Treasurer. Mr. Farrell also served as Executive Vice President and Chief Financial Officer of Stream Global Services, Inc., a business process outsourcing company. Earlier in his career, Mr. Farrell served as Senior Manager at PricewaterhouseCoopers LLP. Mr. Farrell holds an A.B. from Harvard University, and an M.B.A. from the Darden School at the University of Virginia. Mr. Farrell currently serves on the board and is chairman of the Audit Committee of Questcor Pharmaceuticals, Inc. (QCOR), a biopharmaceutical company focused on the treatment of patients with serious, difficult-to-treat autoimmune and inflammatory disorders.
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem cells and regenerative medicine, including a wide array of proprietary PureStem(TM) cell lines, HyStem(R) hydrogels, culture media, and differentiation kits. BioTime is developing Renevia(TM) (formerly known as HyStem(R)-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority-owned subsidiary Cell Cure Neurosciences Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx(TM) currently being developed for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's subsidiary LifeMap Sciences, Inc. markets GeneCards(R), the leading human gene database, as part of an integrated database suite that also includes the LifeMap Discovery(TM) database of embryonic development, stem cell research and regenerative medicine, and MalaCards, the human disease database. LifeMap Sciences also markets BioTime research products and PanDaTox, an innovative, recently developed, searchable database that can aid in the discovery of new antibiotics and biotechnologically beneficial products. BioTime Acquisition Corporation is a new subsidiary being used to acquire the stem cell assets of Geron Corporation, including patents and other intellectual property, biological materials, reagents, and equipment for the development of new therapeutic products for regenerative medicine. BioTime's lead product, Hextend(R), is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements. Additional information about BioTime can be obtained at biotimeinc.com. |
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From: Savant | 4/25/2013 6:20:00 PM | | | | Geron Unveils Further Work Cuts, Discontinues Discovery Research Program
By Nathalie Tadena Geron Corp. (GERN) unveiled plans to cut its workforce by about a third and discontinue its discovery research and companion diagnostics programs, as the pharmaceutical company looks to focus solely on developing its imetelstat drug for hematologic myeloid malignancies. The company said it is closing its research laboratory facility and reducing its workforce from 64 positions to 44. Geron expects to incur restructuring charges of about $1.9 million this year. The discontinued programs and activities were expected to cost up to $19 million during the periods 2014 through 2015. Geron also said its chief medical officer Stephen Kelsey will leave the company on May 3. Geron plans to focus its resources on hematologic myeloid malignancies and does not plan to advance clinical development of imetelstat, its telomerase inhibitor, in non-small cell lung cancer with short telomeres or in essential thrombocythemia. "Diseases such as myelofibrosis represent the greatest value-creating opportunity for the company because many patients with these diseases have significant unmet medical needs and imetelstat has the potential to be a disease-modifying treatment," said Chief Executive John A. Scarlett. Geron also reported its first-quarter loss narrowed to $11.9 million, or nine cents a share, from $18.7 million, or 15 cents a share, a year earlier. Revenue declined about 39% to $765,000, but expenses fell, too. The latest job cuts come after Geron in December cut its workforce by 40% and stopped developing its treatment for brain cancers, part of efforts to focus on developing imetelstat. Shares closed at $1.17 and were unchanged after hours. The stock has fallen 30% over the past three months. |
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From: Savant | 6/17/2013 5:46:13 PM | | | | Geron reports updated results from its Imetelstat Phase 2 proof-of-concept trial in Essential Thrombocythemia Co announces that updated clinical results from the co's Phase 2 trial of imetelstat in essential thrombocytopenia were presented in an oral session at the Congress of the European Hematology Association. Efficacy Results All 18 ET patients were refractory to, intolerant of or had refused conventional therapies (hydroxyurea, anagrelide and/or interferon-alpha). Platelet counts were reduced in all patients (a 100% hematologic response rate) and normalized in 16 out of 18 patients (an 89% complete response (CR) rate). The JAK2 V617F gene mutation was detected in eight patients. Seven out of the eight (88%) patients achieved 72% to 96% reductions in JAK2 V617F allele burden that qualified as partial molecular responses within three to 12 months of treatment with imetelstat. Molecular PRs were maintained in six of the seven (86%) patients, with a median follow-up of 9.5 months (range 0 to 19 months) after first achieving a response. The median durations of hematologic and molecular response have not yet been reached. Safety Results In the trial, long-term administration of imetelstat was generally well tolerated. There were no new safety signals observed in the six-month update, and no patients discontinued the trial due to drug-related adverse events. The majority of the non-hematologic adverse events were mild-to-moderate in severity, the most frequent assessed as imetelstat-related by investigators being gastrointestinal events and fatigue. No drug-related Grade 4 non- hematologic adverse events were reported. |
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