On 11/17/09, GeoVax (OTCQB:GOVX) announced that the FDA has granted its request for a pre-IND meeting to discuss the proposed Investigational New Drug (IND) application for the Company’s therapeutic vaccine as a treatment for individuals already infected with HIV. The meeting will only take place if the Company is not satisfied or requires some clarification to the FDA's answers to the questions submitted in the pre-IND package.
Following the FDA response to the Pre-IND meeting questions, GeoVax will prepare and submit to the FDA an IND application for the therapeutic trial. A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The IND process is expected to take a number of months to complete and based on the Company's current progress, commencement of the trial is targeted for early 2010.
On 11/17/09, Cerus Corp. (NASDAQ: CERS) announced that the FDA's Blood Products Advisory Committee (BPAC) rendered a positive opinion on the proposed hemostatic efficacy and safety endpoints for a potential U.S. Phase 3 clinical trial of the INTERCEPT Blood System for platelets. The Committee disagreed with the safety margins for the trial proposed by Cerus, and recommended that the trial design include more stringent safety margins for comparing INTERCEPT-treated platelets and conventional platelets. In addition, the Committee rendered a positive opinion on a proposed pathway forward in which successful completion of the proposed Phase III trial would be followed by a post-marketing randomized control study and concurrent staged roll-out of the product.
Cerus reported that it now needs to conduct further discussions with the FDA to agree upon a final protocol and the more stringent safety margins recommended by the Committee may require a clinical trial with a larger number of patients than had been proposed. Cerus expects that it will take at least 12 months to complete the clinical trial preparations and partnering arrangements necessary for commencement of the potential trial. The proposed Phase 3 clinical trial is designed as a randomized, double-blinded, non-inferiority trial to assess the hemostatic efficacy and safety of routine use of INTERCEPT-treated platelets compared to platelets prepared with conventional processes.
On 11/17/09, Discovery Labs (NASDAQ: DSCO) announced that it submitted to the FDA its proposed protocol for a Surfaxin (lucinactant) limited clinical trial. The protocol incorporates a clinical trial design that is primarily intended to assess a pharmacodynamic (PD) response following Surfaxin administration in preterm infants with Respiratory Distress Syndrome (RDS). DSCO proposed this trial design in response to a comment by the FDA that a limited clinical trial could potentially resolve the key remaining issue for approval of Surfaxin for the prevention of RDS in premature infants. DSCO received a Complete Response Letter (CRL) for Surfaxin in April 2009.
At an end-of-review meeting with the FDA on 6/2/09, the FDA suggested that, to increase the likelihood of gaining Surfaxin approval, DSCO could consider conducting a limited clinical trial. On 9/29/09, DSCO held a teleconference with the FDA to discuss, among other things, whether a PD approach would satisfy the FDA's requirement for a limited clinical trial. Typically, PD-based clinical trials primarily assess short-term, physiologic responses to therapy and, therefore, are generally less expensive and of shorter duration than trials that have clinical outcomes as a primary endpoint. DSCO expects to receive the FDA comments early in the first quarter 2010.
On 11/16/09, the FDA approved Qutenza (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia, the nerve pain which can follow shingles. Qutenza delivers a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation, through a dermal delivery system, providing up to 12 weeks of reduced pain following a single one-hour application. It is the first product from NeurogesX (OTCPK:NGSX) to be approved by the FDA.
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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