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. If approved by the FDA for the treatment of opioid dependence, XR-NTX has the potential to be the first and only non-narcotic, non-addictive drug agent available in a once-monthly formulation.
On 11/16/09, Spherix (NASDAQ: SPEX) announced that results of the blinded interim data analysis of the Phase 3 trial demonstrated a significant reduction in variability of HbA1c levels, the primary endpoint of the trial. The observed data to-date indicate that the change in variability of HbA1c from baseline is favorable, and that the current sample size gives the study sufficient power to achieve the statistical significance for protocol defined differences between control and D-tagatose in HbA1c when the study reaches the planned number of patients completing treatment. The interim analysis is a pooled, blinded analysis, conducted by an independent statistics and regulatory consulting firm, and there is no statistical penalty.
The NEET trial is an ongoing double-blind, placebo-controlled clinical study, designed to evaluate the safety and efficacy of D-tagatose for the management of Type 2 diabetes. Pending continuing positive study results and overall progress, Spherix remains on target to complete the Phase 3 clinical trial for D-tagatose and submit a New Drug Application (NDA) in 2010. On 8/17/09, SPEX provided the following update for its ongoing clinical trials of Naturlose (D-tagatose) in the treatment and management of Type 2 diabetes: (1) Expects to complete the Phase 2 Dose-Range clinical trial in mid-2010; and (2) Expects to complete the Phase 3 clinical trial in mid to late 2010.
On 11/16/09, CombinatoRx (NASDAQ: CRXX) announced that on 11/13/09, representatives of Neuromed discussed the pending Exalgo NDA with staff from the FDA. In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo. Based on these discussions with the FDA, Neuromed is working with Mallinckrodt, who owns the commercial rights to Exalgo, to determine the appropriate actions to be taken based on the discussions with the staff of the FDA, which actions may include amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2), which utilizes different criteria to determine the basis for approval of a new drug candidate.
On 7/1/09, CRXX and Neuromed Pharma (privately held) announced a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Final merger terms will be adjusted based upon the outcome of a pending FDA decision for Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone) seeking approval for the treatment of moderate to severe pain in opioid tolerant patients. The rights to Exalgo have been acquired by a subsidiary (Mallinckrodt) of Covidien (NYSE:COV). A FDA Advisory Panel was conducted on 9/23/09 for Exalgo, which has a PDUFA action date of 11/22/09.
On 11/16/09, Human Genome Sciences (NASDAQ: HGSI) announced that it has received a Complete Response Letter (CRL) from the FDA for the Company’s BLA seeking approval of raxibacumab for use in the treatment of inhalational anthrax. HGSI stated that it has responded to all of the Agency’s previous questions and plans to address the current questions outlined in the CRL as well. HGSI reported that it has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile under our contract with BARDA, so it is currently available in the Stockpile for use in the event of an emergency while it completes discussions with the FDA on the BLA.
On 5/21/09, HGSI announced that it submitted a Biologics License Application (BLA) to the FDA for its human monoclonal antibody drug ABthrax (raxibacumab) for the treatment of inhalation anthrax as a first-in-class treatment for the disease that is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services (HHS). On 10/27/09, the Anti-Infective Drugs FDA Advisory Committee voted 16-7, with one abstention, that evidence from animal studies predicted the response in humans. However, the FDA Advisory Panel provided guidance that additional data is needed to show benefit over antibiotics.
The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.
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Disclosure: Long CYTX