AMBI Drug Candidate EradicatesVancomycin-Resistant "Staph" Bacteria in Study of Infected HeartValves
October 1, 1998 10:54 AM
PURCHASE, N.Y.--(BUSINESS WIRE)--Oct. 1, 1998--
Results of Lysostaphin Study Presented at ICAAC Symposium
Company Also Reports Receipt of Grant from the National Institutes of Health
AMBI Inc. AMBI announced results of a preclinical study demonstrating that Lysostaphin, the Company's proprietary antibacterial agent, was used successfully to treat endocarditis, an infection of the heart valves, caused by "staph" bacteria. Formally known as methicillin-resistant, vancomycin-intermediately-sensitive Staphylococcus aureus (MRSA-VISA), these bacteria can cause life-threatening illnesses for which there may be no treatment.
Lysostaphin Results Presented at ICAAC Conference
The Lysostaphin experiment used a rabbit model that closely mimics endocarditis disease in humans, and was performed under the supervision of Gordon Archer, MD, Professor of Medicine and Microbiology/Immunology at Virginia Commonwealth University. The results of this study were presented this week at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego, California.
Study results indicated that Lysostaphin completely eradicated the bacteria in most of the animals, whereas vancomycin, the current treatment of choice for MRSA, did not significantly reduce the number of bacteria. In one of the experiments involving MRSA-VISA, the untreated group of rabbits had an average of about one billion bacteria per infected valve at the end of the experiment. The group treated with the standard dosage of vancomycin still averaged between 100 million and one billion bacteria per infected valve. In contrast, 5 of 6 rabbits treated with Lysostaphin had no detectable bacteria and the sixth animal had less than one hundred bacteria per infected valve.
The emergence of bacteria resistant to even the newest and most potent antibiotics strongly suggests that the so-called "super bugs" have the potential to win the infectious disease war. Consistent with this concern, Dr. Archer said, "The recent discovery of vancomycin-resistant strains of S. aureus underscores the need for novel agents for treatment of life-threatening staphylococcal infections. Because of its rapid bactericidal action and unique mechanism of action, we believe Lysostaphin has the potential to augment vancomycin and beta-lactam antibiotics as first line treatment for S. aureus infections."
Lysostaphin is an enzyme that is being developed by AMBI as a potential treatment for serious infections, including endocarditis, caused by drug-resistant S. aureus. Staphylococcal infections occur in approximately 500,000 hospitalized patients each year in the US. The mortality rate from infectious endocarditis caused by S. aureus is approximately 30 percent, and about 50 percent of the infected patients require surgery to replace infected heart valves damaged by the bacteria.
AMBI Receives Grant From the National Institutes of Health
Separately, AMBI announced that it received a Phase I Small Business Technology Transfer grant from the National Institutes of Health to fund further work on Lysostaphin. Dr. Archer is the Principal Investigator on this grant. The Phase I feasibility study is entitled "Lysostaphin for Staphylococcal Endocarditis." AMBI indicated that upon successful completion of the $100,000 Phase I feasibility study, it plans to apply for a Phase II award of up to $500,000 to fund further research on this potentially important new product.
AMBI is seeking a corporate partner to co-develop and commercialize Lysostaphin as a potential treatment for serious infections with drug-resistant S. aureus. AMBI holds patents on the cloned Lysostaphin gene and on other Lysostaphin technology.
Novel Agents Required to Overcome Drug Resistance to Existing Products
Franklin D. Lowy, MD, Professor of Medicine at the Albert Einstein College of Medicine in New York, commented, "The incidence of S. aureus infections, including endocarditis, has increased over the last ten years. Because these infections continue to have a high mortality rate, we need novel agents to combat S. aureus, particularly in view of the likely increase in vancomycin resistance in the future. Vancomycin has limited, if any, efficacy against these pathogens."
Dr. Lowy is the author of a recent article on S. aureus that appeared in The New England Journal of Medicine. Based on data collected by the Centers for Disease Control and Prevention, Dr. Lowy reported that during the past 10 years, S. aureus infections have more than doubled in Intensive Care Units, and today more than 40% of these infections are resistant to methicillin and most other antibiotics.
Preliminary results in the Lysostaphin development program are encouraging. However, it is important to note that the development of Lysostaphin as a therapeutic agent for bacterial infections can be a long, difficult, and expensive process. Notwithstanding any favorable outcomes reported herein, there can be no assurance that a Lysostaphin product will be approved by the FDA or its regulatory equivalent in a foreign country.
AMBI develops and markets nutrition products primarily in the area of cardiovascular disease and diabetes and pharmaceutical products for infectious diseases.
The statements in this press release that are not historical facts are forward-looking statements based upon current expectations. Such forward-looking statements involve risks and uncertainties, including risks and uncertainties set forth in "Risk Factors" and elsewhere in AMBI's Registration Statement on Form S-3 and the Prospectus dated May 12, 1998 and AMBI's Form 10-K/A2 for the year ended June 30, 1997. Actual results and timing of certain events could differ materially from those indicated in the forward-looking statements as a result of these and other factors.
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