Geron Corporation
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| Public | |
| Traded as | NASDAQ: GERN |
| Industry | Biotechnology |
| Founded | 1990 |
| Headquarters | Menlo Park, CA |
Key people | Dr. John Scarlett: President and CEO; David L. Greenwood: CFO; Michael D. West, PhD: founder |
| Products | Cancer drugs (currently in human trials) |
| Revenue |
 $3.277 Million USD (2006) |
 -$31.365 Million USD (2006) | |
Number of employees | 103[1] |
| Website | www.geron.com |
Geron Corporation is a biotechnology company located in Menlo Park, California that specializes in developing and commercialization of therapeutic products for cancer that inhibit telomerase.
Company information
Geron, based in Menlo Park, California, was founded by gerontologist Michael D. West, now CEO of BioTime (NYSE MKT: BTX),[2] who secured initial venture capital investment in the company from Kleiner Perkins Caufield & Byers and Venrock.[3] The company was incorporated in 1990 and began doing business in 1992. The current chief executive officer is John A. Scarlett.
The company's Scientific and Clinical Advisory Board has included James Thomson, Leonard Hayflick, Carol Greider, and others.[4]
Geron was included in the SCCC Index, a 15 stock index of companies important "to the field of stem cell, cloning, and cell transplantation research and medicine" when that index was created in 2003.
Drug candidates
Cancer therapies
Currently, Geron Corporation has two anti-cancer products in human clinical trials.
- The first, called GRN163L, is a drug that targets telomerase. In studies conducted at Johns Hopkins University, GRN163L was active against both CD138+ and CD138neg cancer stem cells and eliminated the colony forming potential of both by five weeks. Similarly, GRN163L inhibited the in vitro clonogenic growth of CD138neg Multiple Myeloma Cancer Stem Cells isolated from the bone marrow aspirates of patients with multiple myeloma. Presently Geron is recruiting patients for six clinical trials using GRN163L,[5] including lung cancer, chronic lymphocytic leukemia[6] and solid tumors.[7] On November 3, 2014, the FDA removed the full clinical hold on imetelstat and declared the company's clinical development plan as acceptable.[8]
- Also in trials at Duke University is GRNVAC1, a telomerase vaccine being used on patients with prostate cancer. With the vaccine, Geron plans to inject telomerase into the patient with metastatic prostate cancer to induce the body to produce a more aggressive immune response to the cancer. Geron's progress with telomerase vaccines attracted a modest monetary investment in 2005 from Merck.[9]
Aug 2012 : GRN1005, an LRP-directed conjugate of paclitaxel, was in phase II clinical trials for brain cancer.
Telomerase activation
In addition to testing drug candidates that exploit cancer cell's dependence on telomerase, Geron is researching the possible applications of activating the enzyme in normal cells to delay cellular senescence. The company is in the early stages of developing a telomerase based treatment for HIV called TAT0002, which is the saponin cycloastragenol in Chinese herb Astragalus propinquus.[10] Geron has granted a license to TAsciences.com to sell TA-65, the telomerase activator agent also derived from astragalus. In October 2010 Intertek/AAC Labs, an ISO 17025 internationally recognized lab, found the largest component of TA-65 to be Cycloastragenol.[11]
Geron originally investigated telomerase as a means of understanding and modifying human aging. However, Geron has ceased aging research of any kind.
Stem cell therapies
On January 23, 2009, Geron received FDA approval to begin Phase I testing of GRNOPC1 in humans.[12] GRNOPC1 is an embryonic stem cell based drug that is designed to treat specific forms of spinal cord injury through remyelination of damaged axons. This trial does not involve direct use of stem cells however, as GRNOPC1 is composed of oligodendrocyte progenitor cells derived from embryonic stem cell lines. Studies have shown significant restoration of mobility in animals with spinal injuries that received cells.[13]
Geron also has several other embryonic stem cell treatments that are still in the preclinical phase, including GRNCM1, a treatment for heart disease, and GRNIC1, a treatment for diabetes. In tests with diabetic mice, 80% of the mice given GRNIC1 were still alive in 50 days while the entire control group, which was given no treatment, perished.[14]
GRNOPC1
As of October and November 2010, One of Geron's most highly publicized trial therapy products has been GRNOPC1, a stem cell therapy designed to heal severe spinal cord injuries. The cells in the GRNOPC1 therapy have been coaxed into becoming early myelinated glial cells, a type of cell that insulates nerve cells. For every GRNOPC1 cell that is injected in the patient, they become six to 10 cells in a few months.[15] In Oct 2011 updated results on 4 patients were released.[16] The trial was discontinued in Nov 2011.
As of 24 July 2012, Geron appear to have stopped work on stem cell technology due to financial constraints.[17]
Patents
Since it was organized in 1990 Geron has been granted over 260 patents.[18]
Patent issue
Geron Corporation initially held exclusive rights to three cell types derived from embryonic stem cells, as the result of paying for the research originally conducted by Dr. James Thomson at the University of Wisconsin–Madison.[19] The patents on the other three cell types are owned by the Wisconsin Alumni Research Foundation (WARF). WARF and Geron did not charge academics to study human stem cells but did charge commercial users. In 2001 WARF came under public pressure to widen access to human stem-cell technology, and they launched legal action against Geron Corporation to recover some of the previously sold rights. The two sides agreed that Geron would keep the rights to only three cell types.[20]
In October 2006, a legal challenge was mounted to overturn these patents by The Foundation for Taxpayer and Consumer Rights and the non-profit patent-watchdog Public Patent Foundation.[21] They contended that two of the patents granted to WARF are invalid because they cover a technique published in 1992 for which a patent had already been granted to an Australian researcher. Another part of the challenge came from the molecular biologist Jeanne Loring who stated that University of Wisconsin–Madison stem cell pioneer James Thomson's techniques (currently patents held by WARF) are rendered obvious by a 1990 paper and two textbooks.[22] The outcome of this legal challenge was particularly relevant to the Geron Corporation as it can only license patents that are upheld.[23] The patents were ultimately upheld when the reexamination concluded in 2008.[24]
As an interim measure, on January 23, 2007 WARF relaxed the stem cell patents, allowing industry-sponsored research at academic and non-profit institutions without a license.[25] WARF will allow easier and simpler cost free cell transfers among researchers and would not require a license or agreement from California's taxpayer-funded stem cell research program.[26]
Politics
As a participant in the then-controversial stem cell and cloning area, Geron Corporation was asked to testify about its technology before the U.S. Congress. In 2001, when Congress was attempting to ban all forms of cloning, Geron CEO Thomas Okarma spoke before Congress to preserve cloning for therapeutic purposes. [27][28][29]
References
- ↑ GERN: Profile for GERON CORP - Yahoo! Finance
- ↑ Pollack, Andrew (May 18, 2011). "A Blood Test Offers Clues to Longevity". New York Times.
- ↑ "SEC Schedule 13G, filed Feb. 17, 1999".
- ↑ "Geron Corporation 10K 1996".
- ↑ Search for GRN163L on ClinicalTrials.gov
- ↑ ClinicalTrials.gov: Safety and Dose Study of GRN163L Administered Weekly to Treat Patients With Chronic Lymphocytic Leukemia (CLL)
- ↑ ClinicalTrials.gov: Safety and Dose Study of GRN163L Administered Weekly to Treat Patients With Solid Tumor Malignancies
- ↑ http://www.fool.com/investing/general/2014/11/03/why-geron-corporation-shares-skyrocketed.aspx
- ↑ "Geron plans stock offering, Merck buying $18M in shares". 12 September 2005.
- ↑ TAT2 (cycloastragenol, CAS Registry no. 84605-18-5)
- ↑ American Analytical Chemistry Laboratories Analysis Document #100710-236 of TA-65
- ↑ "Despite Bush Veto, Stem Cell Research Abounds - Forbes.com". Forbes. Archived from the original on February 4, 2007.
- ↑ Keirstead HS, Nistor G, Bernal G, et al. (May 2005). "Human embryonic stem cell-derived oligodendrocyte progenitor cell transplants remyelinate and restore locomotion after spinal cord injury". J. Neurosci. 25 (19): 4694–705. doi:10.1523/JNEUROSCI.0311-05.2005. PMID 15888645.
- ↑ News: Geron Presents New Data That Document Progress in Development of Therapeutic Products from Human Embryonic Stem Cells. Genetic Engineering & Biotechnology News - Biotechnology from Bench to Business
- ↑ CNN Rachel Meade Reports (October 13, 2010)
- ↑ "Geron (GERN) updates Clinical Data from GRNOPC1 Spinal Cord Injury Trial". 20 Oct 2011.
- ↑ Walsh, Fergus (15 November 2011). "BBC News". Daily Events (BBC News). Retrieved 24 July 2012.
- ↑ Geron - Patents
- ↑ The Badger Herald - WARF, Geron reach settlement
- ↑ Center for Genetics and Society : How a University's Patents May Limit Stem-Cell Research
- ↑ _Science_, 2006
- ↑ Nature Reports Stem Cells 8 November 2007
- ↑ Center for Genetics and Society : Stem Cell Patents Come Under Fire
- ↑ WARF press release
- ↑ SignOnSanDiego.com > News > Business > Biotechnology - Stem cell scientists shout out hallelujah
- ↑ > Wisconsin Group Eases Stem Cell Patent Restrictions After FTCR - PUBPAT Legal Challenge. PUBPAT (2007-01-23). Retrieved on 2013-09-05.
- ↑ Herper, Matthew (April 5, 2001). "Geron's Cloning Quandary - Forbes.com". Forbes.
- ↑ BW Online | June 2, 2003 | Online Extra: Thomas Okarma: Don't Ban Stem-Cell Research
- ↑ H.R. 1644, Human Cloning Prohibition Act of 2001, and H.R.____, Cloning Prohibition Act of 2001