Firm is looking for partners for hESC-derived cell therapy programs.
Financial pressures have led Geron to sideline its stem cell development programs and axe 38% of its workforce. The firm says it will now concentrate its resources on continued development of its Phase II-stage anticancer candidates, imetelstat and GRN1005. However, it will retain a core group of employees from its stem cell operations for the next few months and is actively looking for partners with the technical and financial resources to enable the programs to continue. In the meantime, further enrolment into a trial evaluating GRNOPC1 in spinal cord injury will be stopped, although currently enrolled patients will be followed and data collected.
“By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital,” comments CEO John A. Scarlett, M.D. “This would not be possible if we continue to fund the stem cell programs at the current levels.”
In its third quarter results (period ending September 30), released less than two weeks ago, Geron reported a net loss of $19.5 million, compared with $18.3 million during the equivalent 2010 period. Net loss for the first nine months of 2011 was $65.0 million, compared with $52.0 million in the same 2010 period. The company ended this third quarter with $180.8 million in cash and investments. It says it expects to end 2011 with cash and investments of over $150 million.
Geron’s stem cell program has been focused on the development of human embryonic stem cell (hESC) derived glial cells, cardiomyocytes, islet cells, and chondrocytes. The lead candidate in the program, GRNOPC1, is an hESC-derived oligodendrocyte product that started in a Phase I spinal cord injury study in October 2010. The firm says the study is the first FDA-approved clinical trial of a cellular therapy derived from hESCs.
The company will now focus on two of its cancer candidates. Its lead lipid-conjugated oligonucleotide-based telomerase inhibitor imetelstat is currently being evaluated in four Phase II studies for the treatment of non-small -cell lung cancer, breast cancer, essential thrombocythemia, and multiple myeloma. Online data from the studies are expected by the end of 2012.
GRN1005 is an LRP-directed peptide-drug conjugate, in development for the delivery of drugs across the blood brain barrier. GRN1005 is composed of three molecules of paclitaxel linked to a proprietary peptide that targets the blood brain barrier surface protein, lipoprotein receptor-related protein-1 (LRP-1). Geron licensed the peptide technology from Angiochem in December 2010.
Two Phase II trials with GRN1005 are due to start this year. One will evaluate the drug as a treatment for brain metastases from non-small-cell lung cancer, and the other will be carried out in patients with brain metastases from breast cancer. Top-line data from the two studies are projected by mid-2013.