Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
AstraZeneca (NYSE:AZN): On 5/11/09, AZN announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus Plavix (clopidogrel), in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death.
In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the phase II studies. Given the size of the PLATO trial, further analysis of the entire database, secondary variables, and subgroups is ongoing. AstraZeneca and the PLATO Executive Committee’s aim is to submit the PLATO data to a peer-reviewed medical journal and present at the European Society of Cardiology annual meeting in August 2009 and submit for regulatory approvals during 4Q09.
Discovery Labs (NASDAQ:DSCO): On 5/11/09, DSCO announced that it has received written notice from the FDA that an end-of-review meeting has been scheduled for 6/2/09 to determine the resolution of the remaining primary issue necessary for the Company to gain U.S. marketing approval of Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Following the meeting and receipt of formal written minutes from the FDA, DSCO plans to provide an update, including the expected timeline for the potential approval of Surfaxin.
On 4/17/09, DSCO Discovery Labs received a Complete Response Letter from the FDA for Surfaxin. In its letter, the FDA focused primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before Surfaxin can be approved. The FDA questioned whether the BAT can adequately distinguish change in Surfaxin drug product over time and whether DSCO has adequately validated the BAT and determined its final acceptance criteria.
Discovery Labs intends to rely on data already submitted to the FDA, as well as limited existing data, to support the comparability of Surfaxin clinical drug product to commercial Surfaxin drug product and demonstrate that the BAT can adequately distinguish change in Surfaxin over time and is an appropriate test for monitoring Surfaxin biological activity throughout shelf-life.
Molecular Insight Pharma (NASDAQ:MIPI): In March 2009, MIPI provided positive detailed data on Phase 2 clinical trial for Zemiva. In the trial, the combination of Zemiva imaging with initial clinical diagnostic information resulted in improved sensitivity for detecting ischemia (85%) that was statistically significant (p < 0.0001), when compared to the sensitivity of the initial clinical diagnosis alone (52%). Zemiva enables rapid detection of acute cardiac ischemia in the emergency room setting. The FDA has indicated that a single Phase 3 trial, with robust results, would be sufficient to support Zemiva's approval. The Company's goal is to obtain FDA agreement on a Phase 3 study protocol by the end of 2009 and to begin the trial in early 2010.
MIPI has a Special Protocol Assessment (SPA) letter in place from the FDA which approves the design of a pivotal Phase 2 trial for registration of the Company's lead oncology candidate, Azedra (Ultratrace Iobenguane I 131, formerly known as Ultratrace MIBG). The pivotal Phase 2 study (IB-I2b) will be a single-arm trial conducted in 58 adults with pheochromocytoma.
MIPI plans to complete a Phase 3 clinical trial development program for Europe and initiate a study in the U.S. for Onalta that would validate an imaging surrogate for the candidate. Onalta is the Company's radio-therapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy.
Electro-Optical Sciences (NASDAQ:MELA): MELA has a binding Protocol Agreement with the FDA for MelaFind as a new diagnostic screening device for melanoma, which includes expedited review (180 days expected) for the Company's pre-market approval (PMA) application, would receive expedited review. In February 2009, MELA reported positive top line results from the MelaFind pivotal clinical trial, which was conducted at seven clinical sites and included 1,831 pigmented skin lesions from 1,383 patients.
MELA expects to file the PMA for MelaFind during 2Q09. On 5/8/09, MELA announced a $45M Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Limited which provides the Company with the option to access up to $45M in financing through the sale of newly-issued shares of its common stock over the next three years under the terms and restrictions outlined in the deal.
T-DM1: This TAP compound comprises ImmunoGen's DM1 cell-killing agent linked to the HER2-binding antibody, trastuzumab. It is in development by Roche (OTCQX:RHHBY) through its acquisition of Genentech. Patient enrollment was completed in March 2009 in the Phase 2 trial evaluating T-DM1 as a third-line treatment for HER2-positive metastatic breast cancer. Enrollment in this 100-patient, multi-center study began in July 2008. Genentech expects final study data by 1Q10 and has stated that, if the data from this study are compelling, it will discuss an earlier approval path with the FDA.
Final results from the 100-patient "second-line plus" Phase II trial for T-DM1 will be reported at the upcoming ASCO annual meeting. Patient enrollment in this trial began in mid-2007 and was completed by mid-2008. ASCO is the American Society of Clinical Oncology Annual Meeting being held May 29 - June 2, 2009.
IMGN901: This ImmunoGen TAP compound is in clinical testing for the treatment of CD56-positive multiple myeloma (Study 003) and solid tumors (Study 002). Both Studies 003 and 002 are Phase 1 dose-escalation trials, with IMGN901 given as a single agent to patients whose cancer has progressed on the approved treatments for their disease. Dose escalation has completed in Study 003, a key step to establishing the maximum tolerated dose (MTD).
This study includes an expansion phase in which additional patients will receive IMGN901 at the MTD. Data from Study 003 are expected to be reported at a clinical conference during 4Q09. Dose escalation is ongoing in Study 002, with data presentation expected during 4Q09.
IMGN242: This ImmunoGen anticancer compound is in Phase 2 testing for the treatment of CanAg-expressing gastric cancer that failed first-line treatment. Early data from this trial will be reported in an abstract at the ASCO annual meeting and IMGN expects to determine in 2009 whether this study will be expanded or concluded.
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