Geron Corporation

Geron Corporation

Type	Public NASDAQ: GERN
Industry	Biotechnology
Founded	1990
Headquarters	Menlo Park, CA
Key people	Dr. Thomas B. Okarma: President and CEO; David L. Greenwood: CFO
Products	Cancer drugs (currently in human trials); Stem cell therapies for spinal cord injuries (human safety trial to start in 2009[1])
Revenue	$3.277 Million USD (2006)
Net income	-$31.365 Million USD (2006)
Employees	103[2]
Website	www.geron.com

Geron Corporation is a biotechnology company located in Menlo Park, California that specializes in developing and commercialization of products in three specific areas: 1) therapeutic products for cancer that inhibit telomerase; 2) pharmaceuticals that activate telomerase in tissues impacted by cell aging, injury or degenerative diseases; and 3) cell-based therapies derived from human embryonic stem cells for treatment of various chronic diseases^[3].

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 and has been shown to be effective in treating various cancers in animals.^[4] 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] 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. This vaccine has also produced significant initial results. Geron's progress with telomerase vaccines attracted a modest monetary investment in 2005 from Merck.^[8]

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 from astragalus which is actually the saponin cycloastragenol in Astragalus^[9]. Geron has granted a license to TAsciences.com to sell TA-65, the telomerase activator agent derived from the Chinese astragalus plant. In October of 2010 Intertek/AAC Labs, an ISO 17025 internationally recognized lab, found the largest component of TA-65 to be Cycloastragenol^[10].

Stem cell therapies

On January 23, 2009, Geron received FDA approval to begin Phase I testing of GRNOPC1 in humans ^[11]. 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 ^[12]. 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^[13].

Patents

Since it was organized in 1990 Geron has been granted over 260 patents^[14].

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.^[15] 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.^[16]

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.^[17] 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.^[18] The outcome of this legal challenge was particularly relevant to the Geron Corporation as it can only license patents that are upheld.^[19] The patents were ultimately upheld when the reexamination concluded in 2008.^[20]

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.^[21] 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.^[22]

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.^[23]

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. ^[24][25][26]

Company information

Geron was founded by Dr. Michael D. West and is based in Menlo Park, California. The company was incorporated in 1990 and began doing business in 1992. Its current chief executive officer is Dr. Thomas B. Okarma, M.D., Ph.D.

It 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 and as of July 2006 comprises 18.42% of the index^[27].

References

1. ^ Geron press release January 23 2009: Geron Receives FDA Clearance to Begin World's First Human Clinical Trial of Embryonic Stem Cell-Based Therapy
2. ^ GERN: Profile for GERON CORP - Yahoo! Finance
3. ^ Geron corporate web site
4. ^ Geron Announces Data on the Effects of Its Cancer Drug, GRN163L, on Multiple Myeloma at the American Society of Hematology Annual Meeting
5. ^ Search for GRN163L on ClinicalTrials.gov
6. ^ ClinicalTrials.gov: Safety and Dose Study of GRN163L Administered Weekly to Treat Patients With Chronic Lymphocytic Leukemia (CLL)
7. ^ ClinicalTrials.gov: Safety and Dose Study of GRN163L Administered Weekly to Treat Patients With Solid Tumor Malignancies
8. ^ "Geron plans stock offering, Merck buying $18M in shares". 12 September 2005. http://www.bizjournals.com/sanjose/stories/2005/09/12/daily2.html. 
9. ^ TAT2 (cycloastragenol, CAS Registry no. 84605-18-5)
10. ^ American Analytical Chemistry Laboratories Analysis Document #100710-236 of TA-65
11. ^ "Despite Bush Veto, Stem Cell Research Abounds - Forbes.com". Forbes. http://www.forbes.com/technology/2006/07/21/stem-cell-research-cz_kd_0721stemcell.html. ^{[dead link]}
12. ^ 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. 
13. ^ 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
14. ^ Geron - Patents
15. ^ The Badger Herald - WARF, Geron reach settlement
16. ^ Center for Genetics and Society : How a University's Patents May Limit Stem-Cell Research
17. ^ _Science_, 2006
18. ^ Nature Reports Stem Cells 8 November 2007
19. ^ Center for Genetics and Society : Stem Cell Patents Come Under Fire
20. ^ WARF press release
21. ^ SignOnSanDiego.com > News > Business > Biotechnology - Stem cell scientists shout out hallelujah
22. ^ http://www.pubpat.org/warfstemcelleased.htm
23. ^ http://pagingdrgupta.blogs.cnn.com/2010/10/11/first-human-injected-in-human-embryonic-stem-cell-trial/?replytocom=86296 CNN Rachel Meade Reports (October 13, 2010)
24. ^ "Geron's Cloning Quandary - Forbes.com". Forbes. April 5, 2001. http://www.forbes.com/2001/04/05/0305cloning.html. 
25. ^ BW Online | June 2, 2003 | Online Extra: Thomas Okarma: Don't Ban Stem-Cell Research
26. ^ H.R. 1644, Human Cloning Prohibition Act of 2001, and H.R.____, Cloning Prohibition Act of 2001
27. ^ Stem Cell Stocks : companies, profiles and links

External links

• Corporate web site