First Quarter 2011 Highlights:
Geron scientists and collaborators at The Hospital for Sick Children and the University of Toronto published preclinical data in Clinical Cancer Research demonstrating that the company’s telomerase inhibitor drug, imetelstat, selectively targets cancer stem cells in pediatric tumors of neural origin. Preclinical studies have now shown imetelstat to have activity against cancer stems cells from all nine tumor types tested, spanning adult, pediatric, solid, liquid, epithelial and non-epithelial derived cancers. The findings support the rationale for conducting an investigator sponsored clinical trial in pediatric tumors.
The first patient was enrolled in a single-agent Phase 2 clinical trial to evaluate the activity of imetelstat in patients with essential thrombocythemia (ET), a chronic disorder arising in blood stem cells in the bone marrow. All four clinical trials in Geron’s Phase 2 program for imetelstat have been initiated. The trials include two large randomized clinical trials in non-small cell lung cancer (NSCLC) and breast cancer and two single arm studies in multiple myeloma and ET.
A Geron collaborator from the University of Washington Medical School presented preclinical study data showing positive effects of GRNCM1 in a small animal model of acute heart damage. The results suggest that GRNCM1 positively impacts cardiac function through several mechanisms, leading to overall increased cardiac output and decreased arrhythmias in the acute infarct setting. Geron is developing GRNCM1 for the treatment of myocardial disease.
Geron hosted a webcast analyst and investor meeting on March 29 to discuss the company’s oncology programs.
The presentation provided an update on the Phase 2 clinical program for the company's telomerase inhibitor drug (imetelstat sodium - GRN163L). Enrollment for the two large randomized trials in NSCLC and breast cancer was reported as ahead of projections.
The Phase 2 clinical development plan for the recently in-licensed peptide-conjugated paclitaxel derivative designed to penetrate the blood-brain barrier (GRN1005) was outlined for the first time. Geron is planning for the GRN1005 Phase 2 program to initiate at the end of 2011 in patients with brain metastases. Additional studies in primary brain tumors are under discussion.
Geron hosted a webcast analyst and investor meeting on April 19 to discuss the company’s cell therapy products derived from its human embryonic stem cell platform. The presentation included new data on GRNOPC1 (oligodendrocyte progenitors), GRNCM1 (cardiomyocytes) and GRNIC1 (immature islet cells).
Safety data from the Phase 1 clinical trial of GRNOPC1 in subacute, complete, thoracic spinal cord injury were presented for the first time. The first patient to be enrolled in the study has completed the Day 180 follow-up visit with a clean safety profile showing no Serious Adverse Events (SAEs) and no Adverse Events (AEs) related to the injection procedure or GRNOPC1 (two mild AEs related to immunosuppressive drug included nausea and low magnesium). No significant change in neurological status and no adverse changes or evidence of cavitation on MRI has been observed. Immune monitoring showed no evidence of immune responses to GRNOPC1 through Day 90 (30 days after withdrawal of immunosuppressive drug).
New preclinical efficacy data on GRNCM1 from a study in a chronically infarcted pig model showed statistically and clinically significant functional improvement (ejection fraction) compared to untreated controls. These are important data in an animal model with a heart of similar size and structure to humans.
New preclinical efficacy data on GRNIC1 were reported showing the restoration and maintenance of glucose control for up to 120 days in a rodent model of Type 1 diabetes, compared to a lack of glucose control leading to death of control animals within 20 days.
A new leadership structure was implemented through the appointment of David L. Greenwood as President, Interim Chief Executive Officer and a member of the Board of Directors, Hoyoung Huh, Ph.D., M.D., as Executive Chairman of the Board and Alexander E. Barkas, Ph.D. as Lead Independent Director.
Conference Call
At 8:00 a.m. PDT/11:00 a.m. EDT on April 28, 2011, David L. Greenwood, Geron’s president, will host a conference call to discuss the company’s first quarter results.
Participants can access the conference call via telephone by dialing 800-573-4840 (U.S.) or 617-224-4326 (international). The passcode is 23275594. If accessing the conference call by telephone, please dial in at least 10 minutes early to minimize any delay in joining the call. A live audio-only Webcast is also available through a link that is posted on the events page in the investor relations section of Geron’s Web site at geron.com. The audio Web broadcast of the conference call will be |
