Three years ago, I decided to switch careers and enter the health care industry. It was around this time that I blogged about Geron receiving approval to begin a clinical trial to test its stem cell therapy for patients with spinal chord injuries. It was an exciting time for the Biotech industry and people like me who were entering it – stem cells, once pure science fiction, were about to become reality.
Then, in November 2011, Geron announced that it was jettisoning its stem cell business. Citing difficulty in recruiting patients into its trial and the general cost of its stem cell program, Geron decided to focus on its two cancer drugs: Imetelstat (telomerase inhibitor) and GRN1005 (LRP peptide-drug conjugate). This decision was certainly difficult for all Geron stakeholders: patients, employees, management, and investors. Geron was founded as a stem-cell company and emerged as the standard-bearer of this industry.
However, with limited cash and reluctant to frequently go to the equity markets to raise money, Geron (and its new CEO) decided to cut its losses and focus on its cancer drugs. When Geron made this announcement, its stock fell from $2.5 to $1.5 per share.
Clearly, the decision to abandon stem cell research was a difficult one. Geron gave up a potential blockbuster drug and monopoly in the spinal chord injury market. In addition, Geron laid off almost all its workforce related to the stem cell program. In fact, it may have even lost its CEO and CFO in this decision.
However, in recent months, the stock has crept back up to pre-announcement levels. I believe that Geron made the right decision. If running the stem cell program was bankrupting the company and preventing it from funding its promising cancer drugs, then the stem cell program needed to go. It is unfortunate that Geron lost a lot of great researchers in the process. I only hope that another company can pick up Geron’s trial where it left off; even if not, Geron has paved the way for other companies to enter the stem cell business. Geron was one of the first companies to work with the FDA on establishing protocols for stem cell trials.
And who knows, if Geron’s cancer drugs become blockbusters, Geron could get back into the stem cell game. It’s important to remember that Geron exited the stem cell business for financial reasons, not because of the ineffectiveness of its stem cell therapy.
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ReplyDeleteHow far are they in developing the cancer drugs? Any pretrial studies so far on those cancer drugs that could excite us? Just curious.
ReplyDeleteIt's in Phase 2. They just enrolled for MBC (Metastatic Breast cancer). They are giving paclitaxel vs. paclitaxel + imtelestat (Geron's drug) with or without Avastin.
DeleteThey are looking at PFS (Progression Free Survival). We will see the results by Q4. Should not blow anything of the charts in terms of efficacy. Might have better safety profile
Geron is always an interesting conversation. The decision to abandon their stem cell platform puts stem cells several years back. Currently, they need to find a buyer and that is difficult to do to divest their platform. The best researchers are out of jobs and would likely join academic settings and work on even more early stage things which are several decades from realizing any commercial value.
ReplyDeleteI believe for something like this the blame has to go to government agencies, private venture firms who continue to back a lot of me-too ideas but are very hesitant to back up game-changing trials with right level of investment (both capital and resources). Geron as a for-profit company made the decision that ensures that they can ensure the survival of the company for the short-term.
Look up Pluristem. They used placenta based stem cells instead of ESC. Pluristem is an Israeli based biotech company. Their first indication is for CLI (chronic limb ischeima). This has a patient population size of about 100M WW compared to 50,000 WW for spinal cord injuries.
So maybe the problem is you can't go for the home run on the first try such as Geron did with spinal cord injuries? You need to go for an indication and proof of concept in areas where recruiting, clinical trials, bio statistics, etc are easy to handle and can be performed for a modest cost then use those resources for more difficult Phase 1 trials and other indications related to nerve/cell regenerations.
Thoughts?