Depomed, Inc. (Nasdaq:DEPO) today announced top-line results from BREEZE 3, a Phase 3 trial evaluating the efficacy and safety of Serada (extended-release gabapentin tablets) for menopausal hot flashes. Efficacy data from the trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks. Data for the key secondary endpoints of frequency and severity at 24 weeks did not achieve statistical significance. Safety results showed that Serada was well-tolerated.
Micromet, Inc. (NASDAQ: MITI) said today it will initiate a Phase 2 trial of Blinatumomab in Relapsed-Refractory acute lymphoblastic leukemia (ALL) this quarter (4Q 2011). In the event that initial results generated from the global Phase 2 trial are compelling, it plans to discuss with the FDA potential avenues to accelerate its path to market.
POZEN Inc. (NASDAQ: POZN) announced today top-line results from study 303, a Phase 3 trial designed to track the long-term safety of PA32540 in patients who are at risk for developing aspirin-associated gastric ulcers. In this open label study, adverse events were consistent with what would be expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the PA components. The rate of discontinuation due to adverse events was low, and few patients developed major cardiovascular adverse events. Once results of the two ongoing pivotal Phase 3 trials are released in 1H 2012, it plans to file a NDA during the 2H of 2012.
Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today released interim antiviral response and safety data from an ongoing Phase 2b study of setrobuvir in combination with pegylated interferon and ribavirin in genotype 1 hepatitis C patients. 78 percent of treatment-naive patients and 76 percent of patients who had responded inadequately to, or relapsed after, prior treatment had undetectable virus at week 12 (cEVR) while receiving setrobuvir plus P-R, compared to 56 percent and 44 percent, respectively, for patients who received placebo plus P-R. 71 percent of treatment-naive patients who received setrobuvir plus P-R had undetectable virus at week 8 and met the initial response-guided criteria for shortening treatment in this study to 28 weeks from the traditional 48 weeks for treatment with P-R alone.
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC), today announced that the independent Data Safety Monitoring Board (DSMB) of SEAMLESS, the Phase 3, randomized, registration-directed study of sapacitabine in elderly patients with acute myeloid leukemia (AML), recommended that the study should enter the randomized stage as planned.
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) today announced top-line results from the second of its two Phase 3 studies to evaluate the short-term safety and efficacy of two concentrations of REMURA(TM) (bromfenac ophthalmic solution for dry eye) in alleviating the signs and symptoms of dry eye disease. In the EAST study, REMURA was highly effective in treating a sign and symptom of dry eye but was not statistically significantly better than placebo in the entire patient cohort, a common outcome reported in studies testing other dry eye therapies.
ISTA also announced announced statistically significant results from its Phase 3 clinical program for PROLENSA(TM) (bromfenac ophthalmic solution). PROLENSA is a low concentration of bromfenac in a modified ophthalmic solution developed to treat pain and inflammation associated with cataract surgery. In both Phase 3 studies, PROLENSA was statistically significantly better than placebo and met the primary efficacy endpoint of absence of ocular inflammation 14 days following surgery and the secondary efficacy endpoint of elimination of ocular pain one day post-surgery. It plans to file a New Drug Application (NDA) with the FDA for PROLENSA in 1Q 2012.