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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (672)	5/28/2003 2:41:31 PM
From: tuck	Respond to of 2240

>>PRINCETON, N.J., May 28 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today the results of pre-clinical studies of its fully human antibody against anthrax. In a standard pre- clinical animal study conducted by an independent party, rabbits were exposed to lethal doses of anthrax spores by inhalation, received varying doses of antibody, and were observed for two weeks. All of the rabbits in a control group that did not receive the antibody died within days of exposure. In contrast, and at all dose levels tested, the antibody protected the rabbits from the lethal effects of the anthrax bacteria and its toxins to the two-week study endpoint. The pre-clinical study, under a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and Dartmouth Medical School, was conducted at a separate, specially equipped facility. Inhalation anthrax is the most lethal form of illness in humans caused by the Bacillus anthracis bacterium. The bacteria produce several lethal toxins that lead to an overwhelming pneumonia and shock in exposed individuals. This late stage of the illness frequently does not respond to standard antibiotic therapy and is often fatal. The anthrax protective antigen, a protein component of these lethal toxins, initiates the onset of the illness by attaching to cells in the infected person, and then facilitates the entry of additional destructive toxins into the cells. The fully human antibody in development by Medarex targets the anthrax protective antigen and is designed to protect the cells from damage by the anthrax toxins. The antibody was generated by Medarex's UltiMAb Human Antibody Development System(SM). "If we continue to see such encouraging results following further evaluations of our antibody, we could file an IND for this product candidate as early as 2004," said Donald L. Drakeman, President and CEO of Medarex. About Anthrax According to the Centers for Disease Control and Prevention, anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in hoofed mammals and can also infect humans. Symptoms of disease vary depending on how the disease was contracted, but usually occur within seven days after exposure. The serious forms of human anthrax are inhalation anthrax, cutaneous anthrax, and intestinal anthrax. Initial symptoms of inhalation anthrax infection may resemble a common cold. After several days, the symptoms may progress to severe breathing problems and shock. Inhalation anthrax is often fatal.<< snip Cheers, Tuck

To: Icebrg who wrote (672)	6/1/2003 6:15:20 AM
From: Icebrg	Read Replies (1) \| Respond to of 2240

MDX-010 A report from ASCO via Yahoo! ASCO Day 2 by: mouse_dropping (M/Southern California) 06/01/03 01:31 am Msg: 74917 of 74919 I am impressed with the MDX-010 results. The first presentation by Jeff Weber was nicely done. The patient population was Stage III/IV melanoma patients with completely resected disease (tumors surgically removed). Received MDX-010 at 0.3, 1, and 3 mg/kg in combo with melanoma Tyrosinase, gp100, and MART1 melanoma vaccines (the usual suspects). IFA was the adjuvant. Primarily a safety study, but time to relapse was evaluated. Gastrointestinal DLTs were observed, but these were manageable and reversible. This report lessened my safety concerns. They saw an encouraging dose response. No relapses in the high dose group. None of the patients with autoimmune events have suffered relapse. The NCI presentation was impressive. 14 melanoma patients at 3 mg/kg MDX-010 + 2 gp100 peptides. 3/14 responses. 2 of these were COMPLETE responses, which is almost unheard of in melanoma patients. All responders had autoimmune events. The NCI backed down in dose to 1 mg/kg. Preliminary results show 3/24 partial responses and 4 grade III/IV autoimmune events. IMO the results are very encouraging. In cancer therapy, toxicity and efficacy go hand in hand. The toxicity, which seems to be manageable, may be the marker of activity. Nice job by the authors. The development of MDX-010 seems to become a balancing act between the support of vaccine responses and the avoidance of autoimmune side-effects. An unrelated question to Rick, if he is listening. Medarex are planning to test MDX-010 in a HIV setting. Is it possible that the main thrust of such a trial would not be to get the HIV-virus, but to act as a general booster for the immune system, which is degraded by the virus? Erik