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Biotech / Medical : Seattle Biotech -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (40)	1/28/2003 4:14:36 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 70

NIH Extends Study To Evaluate Kaleidos Pharma's Lead Drug Candidate For The Treatment Of AIDS Tuesday January 28, 2:42 pm ET Promising Initial Results Warrant Further Investigation SEATTLE--(BUSINESS WIRE)--Jan. 28, 2003--Kaleidos Pharma, Inc. today announced that the Division of AIDS of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH) will initiate a second study in SIV-infected rhesus macaque monkeys of Kaleidos' proprietary drug, TGF alpha. This new study follows positive results from a recently completed study conducted by NIH in collaboration with Kaleidos Pharma demonstrating that TGF alpha increased both CD4 and CD8 T cell counts in SIV-infected monkeys. "Many of the current HIV drug regimens are not effective in restoring a patient's immune system that has been devastated by the virus," said Dr. Daniel Twardzik, Kaleidos Pharma Vice President of Research. "For this reason, patients remain susceptible to deadly opportunistic infections. Strategies to restore the immune system of HIV/AIDS patients have become a new and burgeoning area of research. In the second study, we are expanding our work to enable more detailed analysis of the response and TGF alpha's mechanism of action." In the first study, TGF alpha was administered in a multi-dose format to SIV-infected monkeys with significant viral loads and depressed CD4 T cell counts. Serial analysis of blood samples from the treated animals showed an average 63% increase in CD4 counts and an 88% increase in CD8 cell counts in response to the drug. In many cases the T cell counts at least doubled and all animals maintained elevated T cell counts through the end of the study period. "In addition to elevated CD4 and CD8 T cells, we also observed an increase in blood platelets, implying that TGF alpha activates early stem cells that subsequently differentiate into each of these cell types," continued Dr.Twardzik. "This is important because it would indicate that TGF alpha is stimulating the production of so-called naive T cells that are programmed by the body to replenish those cells destroyed by the HIV virus. Previous approaches to this problem of immune reconstitution have been limited to expansion of existing cell populations." "Both of our collaborations with NIH are supporting our belief that there will be broad and meaningful therapeutic applications for TGF alpha," commented Dr. John Reno, president, Kaleidos Pharma. "In addition to the AIDS studies, the first primate studies in the Parkinson's disease therapy collaboration with the National Institute of Neurological Disorders and Stroke at the NIH are being completed and we expect a therapy study in Parkinsonian-lesioned primates to start this quarter. We are working on a timetable that includes filing an IND to treat Parkinson's patients with TGF alpha around the end of this year." 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 AIDS and 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 corporate collaborations to advance its drug development. TGF-alpha is the subject of two studies in primate models of Parkinson's disease. One study is sponsored jointly by Centocor, a Johnson & Johnson company and the Johnson and Johnson Corporate Office of Science and Technology. The Surgical Neurology Branch of the National Institute of Neurological Disorders and Stroke (SNB/NINDS) at the National Institutes of Health (NIH) is conducting a second Parkinson's study. The Division of AIDS of the National Institute of Allergy and Infectious Diseases at NIH is evaluating TGF-alpha in the SIV-primate model of AIDS.