[1997]-[BNP7787]-[BioNumerik Treats First Patient with Novel Supercomputer-Developed Investigational Cancer Drug to Address Significant Problems With Current Platinum-Type Chemotherapy]
BioNumerik Treats First Patient with Novel Supercomputer-Developed Investigational Cancer Drug to Address Significant Problems With Current Platinum-Type Chemotherapy <>
SOURCE: PR Newswire
DATE: Friday, September 12, 1997
SAN ANTONIO, Texas, Sept. 11 /PRNewswire/ via Individual Inc. -- BioNumerik Pharmaceuticals, Inc. today announced treatment of the first patient in the Phase I clinical trials of the Company's chemotherapy protecting drug, BNP7787. BNP7787 is a novel investigational agent designed to reduce the harmful side effects of cisplatin and carboplatin, two widely used anticancer drugs. The preclinical development time for BNP7787 required only 18 months and was assisted by the supercomputer simulation of BNP7787's mechanism of action.
The first patient in this Phase I trial for BNP7787 was treated at the University of Chicago Medical Center. Treatment is scheduled to commence later this month at The Johns Hopkins Oncology Center in Baltimore, the second site for the U.S. Phase I trial. Additional Phase I trials are planned for BNP7787 during the next 12 months at leading cancer treatment centers in Europe and Japan.
Although widely used for a variety of cancers including lung, ovarian, testicular, bladder, head and neck, esophageal, and cervical, the administration of cisplatin and carboplatin have major side effects including nausea and vomiting, toxicity to the kidneys and other organ systems, and bone marrow damage. BioNumerik, through the use of its supercomputer enhanced mechanism based approach, has designed BNP7787 to selectively inactivate the toxic forms of cisplatin and carboplatin and to increase the antitumor effect of these drugs. One of the major goals for therapy is to allow the safe administration of higher potent doses of platinum in the outpatient setting.
Frederick H. Hausheer, M.D., BioNumerik's Chairman and Chief Executive Officer stated, "The initiation of this trial is an important milestone in the development of this very promising agent. We have demonstrated in preclinical studies that BNP7787 does not interfere with the antitumor activity of cisplatin and there is reproducible evidence of potentiation or enhancement of cisplatin's antitumor effect in solid rumors while significantly reducing cisplatin's harmful side effects. We have found in our preclinical studies that BNP7787 can safely and effectively protect against up to a 500% increase in the dose intensity of cisplatin, a 100% lethal dose under normal circumstances; this also results in greater tumor cell kill by platinum. To our knowledge, no drug has ever been reported to achieve this level or protection at such a high dose of cisplatin." BNP7787 appears to be less toxic than table salt (NaCl), which is potentially very important for patients because it should not add toxicity to platinum therapy.
Dr. Hausheer added, "We have also recently obtained data indicating that BNP7787 can protect against carboplatin associated toxicity. The ability to safely administer higher and more effective doses of cisplatin and carboplatin to cancer patients may lead to improved patient response rates."
Richard L. Schilsky, M.D., Director of the University of Chicago Cancer Research Center and Principal Investigator for the University of Chicago BNP7787 Phase I trial indicated, "We are extremely pleased to have the opportunity to conduct a Phase I trial of this exciting new agent. BNP7787 has potential to improve the safety and therapeutic index of cisplatin and carboplatin and to hopefully provide meaningful increases in tumor response rates."
Preclinical animal data obtained by BioNumerik indicates that BNP7787 can substantially protect against cisplatin-induced kidney toxicity, bone marrow damage, vomiting, and weight loss while potentiating (enhancing) cisplatin's antitumor effect. For example, complete tumor remissions increased from 13% (with a 50% death rate due to cisplatin toxicities) in cisplatin only treated test animals with an implanted colon carcinoma to a 63% complete remission rate with no treatment related deaths or toxicities in test animals given pretreatment with BNP7787 prior to the same dose of cisplatin. BioNumerik has also confirmed that a single dose of BNP7787 reduces the number of vomiting episodes (75% reduction) and duration of vomiting (89% reduction), in a preclinical model of cisplatin-induced vomiting. Preclinical studies have shown that a single dose of BNP7787 substantially protects against cisplatin induced suppression of white blood cell and platelet counts.
Ross C. Donehower, M.D., Director of Medical Oncology at The Johns Hopkins Oncology Center commented, "BNP7787, which has the potential to make a significant impact on current cancer therapy, is aimed at making platinum therapy safer, and we hope will also result in greater tumor response rates. Commencement of trials on this drug is particularly meaningful because its discovery and design was supported by BioNumerik's mechanism based computational studies and supercomputer simulations."
The preclinical development time for BNP7787 required only 18 months as compared to the current pharmaceutical industry average of about 5.8 years. According to Dr. Hausheer, the rapid discovery and development of BNP7787 would not have been possible without the computational power of Cray Research supercomputers. "Our use of Cray supercomputers is allowing us to take an entirely new approach to developing innovative drugs," said Dr. Hausheer. "With the Crays, we are able to routinely process literally trillions of calculations in the development of a single drug. That capability gives our researchers unprecedented flexibility and creativity to engineer new drug combinations before committing significant laboratory resources to synthesizing the drug. This allows us to find a safer and more effective drug candidate in much less time."
BioNumerik Pharmaceuticals, headquartered in San Antonio, Texas, is an emerging pharmaceutical company with an innovative, proprietary, technology platform for the rapid discovery and clinical development of small molecule based pharmaceuticals for cancer. BioNumerik is a leader in a powerful new area called "mechanism based drug discovery" which integrates medicine, quantum physics, synthetic chemistry, pharmaceutical sciences and supercomputing. BioNumerik views its approach as a fourth generation technology relative to drug screening, automated screening and combinatorial chemistry, and rational drug design. BioNumerik believes its approach has the potential to greatly reduce the time to discover and bring new drugs into clinical development and to reduce the risk of failure in clinical development. The Company has rapidly advanced two compounds into clinical development and a third new compound into late preclinical development.
SOURCE BioNumerik Pharmaceuticals, Inc.
/CONTACT: Frederick H. Hausheer, M.D., Chairman and Chief Executive Officer of BioNumerik Pharmaceuticals, 210-614-1701, or fred@bnpi.com; or Neil Cohen of Noonan/Russo Communications, 212-696-4455, ext. 205, or neil@noonanrusso.com/ /Web site: www.noonanrusso.com/
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