AspenBio Pharma, Inc. (NASDAQ: APPY), effected today a one for five reverse split of its common shares to ensure continued compliance with NASDAQ minimum bid price rule listing requirements. However it only reduced the number of authorized common shares from 60 million to 30 million.
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) announced top-line results from the first of its two Phase 3 studies to evaluate the short-term safety and efficacy of two concentrations of REMURA (bromfenac ophthalmic solution for dry eye) in alleviating the signs and symptoms of dry eye disease. Its Phase 3 safety and efficacy program, which consists of two studies known as EAST and WEST, is being conducted under a Special Protocol Assessment (SPA). Top-line results are from the WEST study; the EAST study is now fully enrolled and it expects to announce top-line results from the EAST study during 4Q 2011. According to preliminary analysis of the top-line results from the WEST study, while REMURA was highly effective in treating a sign and symptom of dry eye, it was not statistically significantly better than placebo, a common outcome reported in studies testing other dry eye therapies. From baseline, both concentrations of REMURA and the placebo showed highly statistically significant improvement in one sign and one symptom. The co-primary end-points identified in the SPA require REMURA to achieve a statistically significant difference from placebo, not baseline, which was not achieved in the WEST Study.
Cytokinetics, Incorporated (Nasdaq: CYTK) said that it intetnds to initiate a Phase 2b clinical trial of CK-2017357 in patients with ALS in 2012. It also anticipates that data will be available from its ongoing Phase 2 multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic clinical trial of CK-2017357 in patients with ALS by the end of 2011. Data will be available from its ongoing Phase 2a Evidence of Effect clinical trial of CK-2017357 in patients with generalized myasthenia gravis by the end of 2011.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), today gave a pipeline update saying that its Phase 3 VISTA-16 study has collected over 175 reported Major Adverse Cardiovascular Events (MACE) that may qualify as a primary endpoint event. VISTA-16 remains on track to accrue the 385th event in early Q1 2012. Enrollment in VISTA-16 will be stopped after a minimum of 385 primary endpoints have occurred. The next substantial DSMB review of clinical safety and efficacy data is planned once 50 percent of the anticipated primary endpoints have occurred and been adjudicated. Enrollment and site initiations for the PEARL-SC study for lupus continue according to its estimated timelines. As of June 30, 2011 enrollment in PEARL-SC had surpassed 50% of target and remains on track to randomize the last patient in Q4 2011.