BioMed Research Reports: Clinical Data (NASDAQ: CLDA), Lpath (OTC: LPTN.OB) Print E-mail
Wednesday, 25 November 2009 21:13
The research download section has been updated to include PDFs for two recent research reports written by Griffin Securities for Clinical Data (NASDAQ: CLDA) and Lpath, Inc. (OTC: LPTN.OB). Lpath received a buy rating with a $5 per share 12-month price target while CLDA was rated a buy with a 12-month price target of $38 per share. Below is a summary of both companies from their respective reports.
Lpath, Inc. is a biotechnology company focused on lipidomics-based therapeutics that target bioactive signaling lipids for treating a wide range of human disease and is the only company to have developed monoclonal antibodies against bioactive lipids. The Company is currently advancing three early-stage (poised to enter Phase 2 clinical studies) drug candidates (ASONEP™; iSONEP™; and Lpathomab™) in addition to a drug-discovery platform known as ImmuneY2™ which Lpath is leveraging to further expand its pipeline.
In early June, Clinical Data announced positive top-line results from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase 3 trial. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the FDA for vilazodone for the treatment of MDD during 1Q10.
CLDA is also evaluating Stedivaze (apadenoson) in an ongoing Phase 3 clinical trial as a cardiac stress imaging agent. Stedivaze is used to identify the symptoms of coronary artery disease (CAD) with patent protection through 2027 and estimated peak sales potential of $523 million. On 11/18/09, CLDA announced the start of the Phase 3 trial of Stedivaze, which is a selective A2A receptor agonist, in development for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) scans (aka cardiac stress tests), which are used to identify symptoms of CAD.
Stedivaze is a highly selective, high affinity agonist of the adenosine A2A receptor. The initiation of the trial followed a meeting with the FDA that reviewed Phase 2 data showing a rapid onset and offset of action following bolus dosing and improved tolerability over marketed products, such as Adenoscan (adenosine) by Astellas Pharma. The trial is expected to enroll approximately 750 patients over an 18–24 month period with an estimated date of 11/30/11 to complete this process.
The 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.
Disclosure: No positions.

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