PLx Pharma Initiates Clinical Trial For PL 2100 - Aspirin-PC

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Stroke;  Blood / Hematology
Article Date: 19 Feb 2008 - 10:00 PDT

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PLx Pharma Inc. announced that is has initiated a Phase 1 clinical trial of PL 2100, also known as Aspirin-PC, its oral drug candidate for equivalent label claims for aspirin under a 505(b)(2) regulatory path. There are two active Investigational New Drug (IND) applications for PL 2100, for prescription and non-prescription uses, with this trial designed to address the regulatory requirements of both. This trial is a randomized, single dose, crossover study that will evaluate the acute safety, tolerability, pharmacokinetics and anti-platelet equivalence of aspirin compared with PL 2100 Aspirin-PC at 325 mg and 650 mg dose levels in approximately 32 healthy volunteers. This trial is a first step in a clinical development program that will investigate PL 2100 Aspirin-PC as an aspirin formulation that is potentially safer for the gastrointestinal (GI) tract.

Aspirin is a widely used drug available over-the-counter for pain and fever relief and as directed by a physician for treatment and prevention of myocardial infarction and stroke. When used alone or in combination with other nonsteroidal anti-inflammatory drugs (NSAIDs) and other drugs, there is a well documented increased risk for life threatening GI complications, including ulcers and GI bleeding. Recent estimates suggest aspirin may be responsible for nearly 50% of NSAID induced mortality. PL 2100 Aspirin-PC is novel formulation of aspirin that combines aspirin with a new gastro-protective agent, phosphatidylcholine (PC).

"PL 2100 Aspirin-PC may represent an alternative treatment for the large number of patients at risk for GI complications from aspirin use alone or when using aspirin with other drugs," said Lenard M. Lichtenberger, Ph.D., the inventor of the NSAID-PC technology, a Professor with the University of Texas Health Science Center at Houston and co-founder of PLx Pharma. "We are excited to begin human testing of what could be an important improvement in a great drug that has been helping people for over 100 years."

About PLx Pharma Inc.

PLx Pharma is a privately owned pharmaceutical company developing GI safer NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen, naproxen and aspirin) utilizing its novel proprietary phospholipid based technology. This technology complexes a natural soy derived phosphatidylcholine (PC) with a traditional NSAID to mitigate NSAIDs GI toxicity. PLx's lead products are GI safer oral complexes with phosphatidylcholine of ibuprofen (PL 1100 Ibuprofen-PC which is in clinical development), naproxen (PL 3100 Naproxen-PC) and aspirin (PL 2100 Aspirin-PC). Parenteral formulations, additional oral NSAID-PC and other drug-PC combinations are also under development.

PLx Pharma Inc.