To: keokalani'nui who wrote (48 ) 5/28/2003 11:41:27 AM From: keokalani'nui Read Replies (1) | Respond to of 70 Press Release Source: Kaleidos Pharma Kaleidos Pharma to Receive Patent for Prevention and Treatment of Gastrointestinal Mucositis Wednesday May 28, 8:05 am ET Company Fortifies its Intellectual Property Position around TGF Alpha SEATTLE--(BUSINESS WIRE)--May 28, 2003--Kaleidos Pharma, Inc. (KPI) today announced that the United States Patent and Trademark Office has issued the company a notice of allowance for a patent application extending coverage on the use of the company's family of growth factor drugs for major indications. The issued patent will cover the use of certain therapeutic compounds, including the company's lead drug candidate, TGF alpha, for the prevention and treatment of gastrointestinal mucositis (GI mucositis), a painful and debilitating side effect often associated with the administration of cytotoxic or immune-suppressing therapies, such as cancer chemotherapeutic drugs. "The impact of gastrointestinal mucositis following intensive chemotherapy is substantial," explained Fred Appelbaum, MD, Professor of Medicine and Head, Division of Oncology, University of Washington and Director, Clinical Research Division, Fred Hutchinson Cancer Research Center. "Not only does it cause substantial pain, nausea, vomiting and diarrhea, but most importantly, it can directly result in a significant increase in infections and death by interrupting a vital barrier to bacterial invasion. The availability of an agent capable of substantially reducing the extent of gastrointestinal mucositis could be of enormous potential benefit in reducing not just the morbidity, but also the mortality of chemotherapy." "Using animal models, we have shown that TGF alpha can limit intestinal damage caused by several commonly administered cancer drugs, including 5-fluorouracil and irinotecan," explained John M. Reno, Ph.D., President of KPI. "We are developing several formulations of TGF alpha and will select one for initial human clinical trials in metastatic colorectal cancer patients receiving chemotherapy, which we hope to begin early next year. "Building a strong intellectual property position around our lead products is fundamental to our ongoing financing and partnering strategies," stated Robert M. Littauer, Chief Executive Officer of Kaleidos Pharma. "This notice of allowance for GI mucositis represents a major milestone as we advance our compounds into the clinic." Kaleidos Pharma, Inc. is a privately held biotechnology company developing cytokine-based drug therapies for central nervous system disorders, including Parkinson's disease, and for certain cancer indications. The Company's lead drug, TGF-alpha, is a potent endogenous stem cell mitogen that also inhibits programmed cell death. KPI has developed a number of academic and government collaborations to advance its drug development. TGF-alpha is the subject of a study in a primate model of Parkinson's disease being conducted by the Surgical Neurology Branch of the National Institute of Neurological Disorders and Stroke (SNB/NINDS) at the National Institutes of Health (NIH) and is also being evaluated in the SIV-primate model of AIDS by the Division of AIDS of the National Institute of Allergy and Infectious Diseases at NIH. -------------------------------------------------------------------------------- Contact: Kaleidos Pharma Bob Littauer, 206/332-0712