On 11/16/09, Cytori Therapeutics (NASDAQ:
CYTX) completed enrollment in a 70-patient, international breast cancer reconstruction study, RESTORE 2. The study is evaluating the use of cell-enriched fat grafting to restore functional and cosmetic deformities in women who have undergone partial mastectomy for early breast cancer. Interim data on the first 32 patients who have reached the six-month follow-up will be presented as a poster at the San Antonio Breast Cancer Symposium on 12/12/0 at 7am (CT) by Mrs. Eva Weiler-Mithoff, MD, lead investigator at the Glasgow Royal Infirmary.
Cytori expects to present six-month data for 15-30 patients while final, 12-month data on all patients is expected in early 2011. The ClinicalTrials.gov identifier is NCT00616135 for the RESTORE-2 study, which is a European study designed to evaluate the transplantation of ADRC-enhanced autologous (patient-derived) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.
On 11/16/09, Poniard Pharma (NASDAQ: PARD) announced that its pivotal Phase 3 SPEAR study of picoplatin did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089. PARD stated that it is contacting the FDA today to request a meeting to discuss a regulatory path and looks forward to presenting the full SPEAR efficacy and safety data at an upcoming medical conference early next year.
On 11/16/09, Alkermes (NASDAQ: ALKS) announced positive preliminary results from a Phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens.
Based on the positive results of this phase 3 study, Alkermes plans to file a supplemental New Drug Application (sNDA) with the FDA during 1H10. XR-NTX, marketed by Alkermes as VIVITROL, is an opioid antagonist administered once-monthly by intramuscular injection and is approved in the U.S. for the treatment of alcohol dependence.
