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MADISON, WI--October 20, 2001--SLIL Biomedical Corp. announced that the FDA has completed its review of the Investigational New Drug application (IND) for SLIL’s candidate drug, SL11047. Phase I human clinical trials with the drug will now commence. The Phase I clinical study, aimed at AIDS-lymphoma patients, will be undertaken by Dr. Lawrence Kaplan at the University of California San Francisco. "This is a vital milestone for SLIL," said CEO, Peter Molloy. "It takes our company out of the preclinical stage and into the clinical development stage. It has been a formidable learning curve, but we are now ready to confidently push forward with the clinical development of other candidate drugs in our pipeline." SL11047 is described by SLIL as a second-generation polyamine analog, and is licensed to SLIL under a patent from the University of Wisconsin Alumni Research Foundation (WARF). "These new cancer compounds employ a drug design strategy, known as conformational restriction, which we believe will offer improved tolerability and efficacy, compared with earlier polyamine analogs," said Molloy. "SL11047 and other compounds under our WARF license were the basis on which our company was founded five years ago, so it is gratifying to see the first of these drugs reach human clinicals." SL11047 is not yet licensed to any pharmaceutical partner, but Molloy states that they are currently in discussions with at least one major oncology company. SLIL is also seeking manufacturing partners to scale up GMP synthesis of the drug for future clinical trials. The Phase I study will evaluate the safety and tolerability, as well as pharmacokinetics, of SL11047 in AIDS patients with non-Hodgkin's lymphoma. Other objectives of the study will be to assess the clinical response to SL11047, and the sensitivity of HIV-infected macrophages to the drug. These aberrant, virally infected macrophages, termed ProMacs™ by SLIL, are thought to be involved in several diseases, including lymphoma. "In vitro, these macrophages are particularly sensitive to SL11047," Molloy said. "What we now hope to see in the trial is that the ProMac levels drop in response to the drug, and in conjunction with any clinical response." The study will also evaluate the impact of the drug on HIV viral load, because the company believes that the ProMacs may be a crucial reservoir for HIV in some AIDS patients. SLIL Biomedical Corp. is a Madison-based, privately held biopharmaceutical company, engaged in the discovery and development of drugs to treat cancer and other proliferative diseases. Polyamine analogs are the centerpiece of SLIL’s drug discovery platform. SLIL also holds the exclusive license to patents from the University of California San Francisco relating to the diagnostic and therapeutic applications of virally modified macrophages, called ProMacs™, thought to be involved in the pathogenesis of several diseases. This announcement may contain forward-looking statements that reflect management’s current view of future events and that are subject to risks and uncertainties. Actual results could differ materially from those currently anticipated as a result of a number of factors, including but not limited to: availability of adequate funding; outcomes of preclinical development and clinical trials; ability to manufacture; cancellation or delay of licenses; dependence on patents; dependence on current and future collaborative partners; ability to manage growth and attract/retain employees; government regulation and health care reforms; consolidations and changes within the pharmaceutical industry. SOURCE: SLIL Biomedical Corp. Contact: Marla K. Johnson SLIL Biomedical Corp.
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