VTUS fails Phase 3 trial. MAPP due to refile NDA by early 4Q. CYTR Phase 2b data due 2013 + LXRX CUR RPTP news
Ventrus Biosciences, Inc. (Nasdaq:VTUS) today reported that its Phase 3, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with hemorrhoidal disease did not meet its endpoints.
CytRx Corporation (NASDAQ: CYTR) announced the recommendation by the Data Safety Monitoring Board (DSMB) to continue with its Phase 2b trial of tamibarotene in combination with chemotherapeutical agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC). Data are expected in 2013. The Company had previously stated in April that they “could have data from the Phase 2b clinical trial by the end of 2012.”
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that it expects to resubmit its New Drug Application (NDA) for LEVADEX for the acute treatment of migraine in adults, in late 3Q/early 4Q 2012. This follows an End-of-Review meeting as a result of receipt of a Complete Response letter (CRL) on March 26, 2012. The Company believes that no new studies need to be conducted for inclusion in the resubmission. In the CRL, the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a facility inspection of a third party manufacturer. The FDA also indicated in the CRL that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) announced that the first patient has been dosed in its Phase 2b clinical trial evaluating the safety and potential efficacy of RP103 as a potential treatment of non-alcoholic steatohepatitis (“NASH”).
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today data from its Phase 2b trial of LX4211 in patients diagnosed with poorly-controlled type 2 diabetes who were concurrently treated with metformin, an established diabetes therapy. The data showed substantial, dose-dependent, statistically-significant reductions in hemoglobin A1c (HbA1c). The primary endpoint of the study was the change in HbA1C, a measure of glycemic control, from baseline to week 12. LX4211 was administered at doses of 75 mg QD, 200 mg QD, 200 mg BID and 400 mg QD. Top-line results showed that patients in the LX4211 treatment arms had mean HbA1C reductions from baseline of 0.43, 0.52, 0.79 and 0.95 percent, respectively (p<0.001 for all treatment arms). In patients randomized to placebo, HbA1C decreased by 0.09 percent. Adverse events were generally mild to moderate, and the overall incidence of adverse events with LX4211 was similar to placebo. There were four serious adverse events, none attributed to treatment, which were equally distributed across treatment groups and placebo. The company intends to initiate a Phase 3 trial during 1H 2013.
Neuralstem, Inc. (NYSE MKT: CUR) announced that the first patients were dosed in Phase Ib of its ongoing trial to test the safety of NSI-189 in the treatment of major depressive disorder (MDD).
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) announced the completion of enrollment in a Phase II trial evaluating bavituximab in combination with gemcitabine versus gemcitabine alone in patients with previously untreated Stage 4 pancreatic cancer. Interim data is expected later in 2012.