San Diego, California - Windy Hill Medical, Inc. presented Phase I clinical study results for intraductally administered carboplatin and pegylated liposomal doxorubicin in a plenary session at the 2008 Annual Meeting of the American Association of Cancer Research (AACR).
Preclinical work in the laboratory of Dr. Sara Sukumar at Johns Hopkins University has shown that administration of cytotoxic agents into the milk duct (intraductally) inhibits development of breast cancer in Her-2/neu and MNU rodent models. When a drug is instilled by catheter into the milk duct of rodents, a higher local tissue level is achieved, while reducing exposure to the whole body.
The Phase I dose escalation study was performed to support the safety of this approach for clinical trials in women prior to mastectomy. Two drugs, pegylated liposomal doxorubicin (PLD) and carboplatin were given intraductally at three escalating dose levels. The breast was removed surgically as planned two to five days post treatment and the treated ducts were marked to enable identification on pathological evaluation. Pathological examination showed the drugs were widely distributed throughout the ductal system reaching terminal duct lobular units, and there was a significant although variable dose-related epithelial cell loss in ducts with dye indicating drug effect. “These results suggest that cytotoxic drugs can be administered into breast ducts with minimal toxicity at appropriate doses,” said Susan M. Love, MD, Lead Investigator who presented the work. “Windy Hill Medical has initiated a U.S. Phase II clinical trial for the treatment of non-invasive ductal carcinoma in situ breast cancer with carboplatin.”
About Windy Hill Medical, Inc. Windy Hill Medical is a drug/device biopharmaceutical company dedicated to developing intraductal treatments for disease conditions of the breast. Our strategy is comprised of delivering commercially available drugs (chemotherapeutic small and large molecule, hormonal agents) locally via the breast ducts to achieve higher tissue levels and reducing systemic toxicity. A commercially available catheter delivery device aids in the identification, atramatic cannulation and instillation of drug or imaging agent into a women’s breast.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Windy Hill Medical, Inc. that involve risks and uncertainties that could cause actual results to differ materially. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that preclinical studies are not indicative of the results of future clinical studies, the possibility that our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks.
