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


To: Icebrg who wrote (764)11/5/2003 6:50:18 AM
From: Icebrg  Read Replies (1) | Respond to of 2240
 
Medarex Announces MDX-060 Presentation at the American Society of Hematology Meeting
Wednesday November 5, 6:13 am ET
Abstract Scheduled to Be Published in Upcoming Issue of BLOOD

PRINCETON, N.J., Nov. 5 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today that preliminary clinical activity data, including one complete response lasting four months, from a "Phase I/II study of a fully human anti-CD30 monoclonal antibody (MDX-060) in Hodgkin's disease (HD) and anaplastic large cell lymphoma (ALCL)" (Abstract #632) is scheduled to be included in an oral presentation in the New Agents session at the 45th Annual Meeting of the American Society of Hematology (ASH). Further data will be presented by Stephen M. Ansell, M.D., Ph.D., of the Division of Hematology, Mayo Clinic, during the ASH meeting, December 5-9, 2003, in San Diego, CA.

In the Phase I/II clinical study, 21 patients with relapsed or refractory HD, ALCL or other CD30-positive lymphomas (without curative options) are reported to have been treated with Medarex's fully human MDX-060 antibody. In the Phase I portion of the trial, which has been completely enrolled, patient cohorts of three to six patients received weekly doses of 0.1, 1.0, 5.0 or 10.0 mg/kg of MDX-060 for 4 weeks. In the Phase II portion of the trial, which continues to accrue patients, expanded cohorts are expected to receive MDX-060 at 10.0 or 15.0 mg/kg.

While efficacy assessments have not yet been completed in all patients, one patient with ALCL in the 1.0 mg/kg cohort group experienced a complete response to therapy of four months duration. One episode of possible drug-related toxicity occurred in the 1.0 mg/kg cohort group. The patient, who had a history of Graft versus Host Disease, developed elevated (Grade 3) liver transaminase levels. No significant infusion-related reactions and no opportunistic infections have occurred. No maximum tolerated dose has been identified. The abstract is available on the ASH website at www.hematology.org and also is scheduled to be published in an upcoming issue of BLOOD, the journal of the American Society of Hematology.

About MDX-060

MDX-060 is a fully human antibody that targets CD30, a member of the tumor necrosis factor receptor superfamily and a molecule found on activated lymphocytes. CD30 has been found to be over-expressed in several lymphoproliferative disorders and is present on malignant cells of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL), as well as other CD30-positive lymphomas. According to the American Cancer Society, in 2003 there will be approximately 7,600 new cases of Hodgkin's disease in the United States, and an estimated 1,300 people will die of the disease. Worldwide, there are nearly 100,000 cases of Hodgkin's lymphoma and ALCL.



To: Icebrg who wrote (764)11/17/2003 6:01:29 AM
From: Icebrg  Read Replies (1) | Respond to of 2240
 
GENMAB AND ACE BIOSCIENCES TO DEVELOP PRODUCT TO TREAT FUNGAL INFECTIONS

Identify First Target in Their Joint Development Collaboration

Summary: Genmab and ACE BioSciences have identified the first target in their collaboration.

Copenhagen, Denmark; November 17, 2003 – Genmab A/S (CSE: GEN) and privately held ACE BioSciences A/S announced today that they will develop an antibody therapeutic product with the potential to treat fungal infections. The antibody will be directed against a novel target on Aspergillus fumigatus. This fungus can cause life threatening infections in patients whose immune systems are compromised, for example cancer patients receiving chemotherapy.

The target discovered by ACE BioSciences is the first in the collaboration between Genmab and ACE BioSciences that covers four commercially promising disease targets in the area of infectious diseases. Under the agreement, ACE BioSciences provides novel commercially promising disease targets and Genmab provides human antibody technology to create and develop new antibody products. The two companies share development costs and commercial rights equally.

“After only two years of operation ACE BioSciences has found and validated a significant number of novel protein targets for new treatments of Aspergillus fumigatus,” said Ejvind Mortz, Ph.D., Chief Executive Officer of ACE BioSciences’. “With Genmab we have chosen a promising novel protein target for which Genmab will use their expertise in developing human antibodies for treatment of aspergillosis.”

“ACE BioSciences’s target discovery skills and Genmab’s antibody development capabilities are an ideal combination for discovery and development of antibody based treatments for infectious diseases,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “Fungal infections are becoming an increasingly urgent health threat and, despite not being adequately treated, currently represent a multi-billion dollar market.”


About Aspergillus fumigatus
Aspergillus fumigatus is an opportunistic pathogen that causes fungal infections in immunocompromised patients but not generally in healthy individuals who are not susceptible to the disease. In recent years the number of patients with invasive aspergillosis has increased significantly, due to three main reasons: first, the increasing use of chemotherapy for treatment of cancer; second, the increase of transplantation patients treated with immunosuppressive drugs; and third, the increased number of patients with suppressed immune systems, such as AIDS patients. Infection can occur in the lungs and in many organs and tissues, such as heart, liver, eye, nose, ear and skeletal muscle, resulting in conditions such as allergic aspergillosis, aspergilloma and invasive aspergillosis. Early diagnosis, treatment and prevention are very difficult. Drugs such as itraconazole have been used for many years as a treatment, but even so, mortality is still as high as 60-90%.

The US antifungal market was approximately $2.9 billion in 2002. The average annual growth rate in this market is 11%, primarily driven by the growing at-risk population.

genmab.dk