COPIAGUE, N.Y., Feb. 24 -- American Biogenetic Sciences, Inc. (ABS) (Nasdaq: MABXA - news) has produced a single isomer version of its lead neurological compound, ABS-103. This single isomer has been shown in predictive animal models to be free of the potential for birth defects associated with valproic acid, one of the world's most commonly used epilepsy treatments. The single isomer R-ABS-103 (R-103) is a more refined version of ABS-103, which itself is a next-generation more potent derivative of valproic acid, a drug that generates annual worldwide revenues in excess of $1 billion.
In predictive animal models, tests conducted by Professor Heinz Nau of the University of Hanover, Germany, R-103 showed equal antiepileptic activity and equal potency to the racemic mixture ABS-103. In addition, while ABS-103 had virtually eliminated the teratogenic potential (tendency to produce birth defects) of valproic acid, tests found that the single isomer R-103 was even less toxic, and totally eliminated such risks in key animal models.
``We are very pleased with this development,'' said John S. North, President and CEO of ABS. ``The FDA has strongly encouraged the pharmaceutical industry to take the development of new drugs to the final stage of isolating the proper isomer -- the version of a compound that has maximum activity against disease, with minimum unwanted side-effects and toxicity. That is precisely what we have achieved with the development of R-103.''
Isomers can be described as mirror images of the same compound. R-103 is an enantiomer which is a specific type of isomer. Although scientists have known about the existence of separate isomers for some 150 years, it is only recently that researchers have been able to isolate either the S (left) or R (right) isomer in the synthesis of drugs. The value of single isomers lies in the fact that often one of the isomers is responsible for the therapeutic effect of a medicine, while the other isomer may be inactive or may cause unwanted side effects or toxicity. The isolation of single isomer drugs has proved particularly successful for pharmaceutical companies such as Marlborough, Massachusetts-based Sepracor, which develops and patents single isomer versions of existing medicines.
``From this point forward, we will be proceeding with R-103,'' said Mr. North. ``We have two issued patents and numerous pending for the compound in each of the world's largest pharmaceutical markets. Our priorities now for R-103 are to complete final preclinical testing currently underway, move the compound into Phase I clinical trials, and strike an agreement with a commercialization partner.''
American Biogenetic Sciences, based in Copiague, New York, researches and develops diagnostic tests for cardiac conditions and infectious diseases, as well as new treatments for neurological disorders including epilepsy, migraine, mania, Parkinsons and Alzheimer's disease. ABS also seeks out new technologies and conducts research and development throughout its Global Scientific Network, in the U.S., Europe, Israel, Russia and China.
Statements in this release that are not strictly historical are ``forward-looking'' statements within the meaning of the Private Securities Litigation Reform Act of 1995, and should be considered as subject to various risks and uncertainties that could cause actual results to differ materially from those anticipated. For further details and a discussion of these risks and uncertainties, see the Company's Securities and Exchange Commission filings, including its annual report or Form 10-K