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

To: Icebrg who wrote (587)	5/14/2002 6:33:57 AM
From: nigel bates	Respond to of 2240

PARIS, May 14 /PRNewswire/ -- Immuno-Designed Molecules, S.A. (IDM), and its US subsidiary, IDM Inc. today announced approval from the Food and Drug Administration to begin a Phase III clinical trial in the treatment of ovarian cancer using IDM's Cell Drug(TM) Osidem® (also known as IDM-1). IDM will carry out the study in association with a number of US teams of cell therapy specialists, led by Professors Ken Hatch, M.D., and Evan Hersh, PhD., from the Arizona Cancer Center at Tucson. Other US clinical and cell preparation centers will begin including patients in the coming months, with the active support of IDM North American clinical research team, based in Montreal, Canada. Dr. Jean-Loup Romet-Lemonne, IDM President and Chief Executive Officer, stated, "This favorable response from the FDA allows us to extend our first Phase III clinical trial to outstanding research teams in the US. This approval from one of the most demanding Regulatory agencies in the world shows its confidence in IDM's Cell Drug(TM) technology and potential interest in the treatment of ovarian cancer." The goal of this cellular immunotherapy treatment from IDM is to eliminate residual tumor cells after surgery and chemotherapy. Osidem® is IDM's most advanced antibody-based Cell Drug for the treatment of cancer. It is comprised of IDM MAKTM (Monocytes-derived Activated Killer) cells associated with a bi-specific anti-HER-2/neu antibody developed by its partner Medarex, Inc. (Annandale, NJ, USA). Already underway in a number of countries in Europe, in Canada and in Australia, the Phase III trial for Osidem® targets patients with Stage III ovarian cancer. The aim is to prolong remission after a positive response to a standard protocol consisting of surgery followed by two chemotherapies.

To: Icebrg who wrote (587)	5/17/2002 6:15:18 AM
From: Icebrg	Read Replies (2) \| Respond to of 2240

Medarex Announces Webcast of MDX-010 Clinical Results Following ASCO Presentations PRINCETON, N.J., May 17 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) will hold a live webcast of data from the MDX-010 clinical trial studies in prostate cancer and malignant melanoma being presented at the 38th Annual Meeting of the American Society of Clinical Oncology. Dr. James Allison, Howard Hughes Investigator and Professor of Immunology and Director of the Cancer Research Laboratory at the University of California, Berkeley, will join Dr. Thomas Davis, Senior Director of Clinical Science, and Dr. Nils Lonberg, Senior Vice President and Scientific Director, both from Medarex, to provide an overview of MDX-010, including a review of certain clinical trial results presented earlier at the conference. The webcast will begin Wednesday, May 22, 2002 at 4:30 PM Eastern time and may be accessed through the Medarex website at medarex.com. Investors interested in listening to the webcast should log on before the presentation begins in order to download any software required. An archive of the presentation will be available on the Medarex website for at least 14 days. and from an October 31, 2001 Press Release. Initial Results of First Human Clinical Trial Using MDX-010 Announced PRINCETON, N.J., Oct. 30 /PRNewswire/ -- Medarex, Inc. (Nasdaq: MEDX) today reported interim findings of ongoing Phase I/II clinical trials of a fully human antibody product, MDX-010, in patients with advanced melanoma or prostate cancer. The findings were presented at the Strategic Research Institute Anti-Cancer Drug Discovery and Development Summit held last week in San Francisco, CA. In the initial human clinical trials, 18 patients with metastatic melanoma and 14 patients with hormone refractory prostate cancer received a single 3 mg/kg dose of the antibody. The data indicate that the product was generally well tolerated. Of adverse events reported, more than 97% were mild to moderate (grade 1 and 2). Signs of immunologic activity included tumor necrosis, inflammatory reactions at tumor sites and relief of symptoms. In addition, after receiving a single dose of MDX-010, two patients with prostate cancer experienced a greater than 50% reduction in serum prostate specific antigen (PSA) measurement that lasted from 3 to 6 months. PSA levels are generally considered to be a marker of disease progression in prostate cancer patients. Based upon this experience, further clinical trials are being initiated that will test repeated dosing of the antibody used alone, as well as combinations of the antibody and other anti-cancer therapies. "Although these initial single dose trials were designed to test primarily for safety, we are excited that the interim results also showed evidence of anti-tumor activity," said Donald L. Drakeman, President and CEO of Medarex. MDX-010 (formerly MDX-101) is a fully human antibody against human CTLA-4, a molecule on T cells that is responsible for suppressing the immune response. Studies in mice have demonstrated that an antibody against CTLA-4 is able to strengthen the innate immune response against certain tumors, leading to the reduction of and, in some cases, the elimination of well-established tumors.