Navigation Links
Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus
Date:8/12/2008

Medarex to Receive Milestone Payment from MedImmune

PRINCETON, N.J., Aug. 12 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) announced today that its partner MedImmune, Inc. has initiated a Phase 2A multi-dose clinical trial of MEDI-545 for the potential treatment of systemic lupus erythematosus (SLE or lupus). MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human Antibody Development System(R). Under the terms of the agreement, Medarex will receive a milestone payment of an undisclosed amount.

The Phase 2A clinical trial is designed to evaluate the safety and tolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo in adult patients with moderate to severe active lupus. The study will also assess the effects of MEDI-545 on disease activity in lupus patients. This randomized, double-blind, placebo-controlled trial is expected to enroll 80 patients and will be conducted at 20 sites in the United States.

MedImmune is also conducting a Phase 1 clinical trial for MEDI-545 in idiopathic inflammatory myositis, an immunological disease that involves chronic muscle inflammation, pain and weakness.

"Data from an earlier reported placebo-controlled Phase 1 study suggested therapeutic activity with single doses in patients with lupus and demonstrated an acceptable safety profile," said Geoffrey M. Nichol, M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We are very excited about the role of the interferon alpha inflammatory pathway and look forward to exploring its potential in treating patients with lupus and other autoimmune diseases."

About MEDI-545

MEDI-545 (previously known as MDX-1103) is a fully human monoclonal antibody targeting interferon-alpha. Published data indicate that levels of interferon-alpha are elevated in many patients with active SLE and other autoimmune disorders, and may be associated with disease activity. Preclinical data from animal models suggest that MEDI-545 may suppress the abnormal immune activity associated with lupus by binding to multiple interferon-alpha subtypes seen in the serum of lupus patients.

In November 2004, MedImmune entered into a collaboration with Medarex to focus on two specific antibodies, one of which was MDX-1103 (now known as MEDI-545). Under the terms of the agreement, MedImmune is responsible for all ongoing clinical development activities. Prior to the beginning of pivotal studies, Medarex may elect to co-develop the products in return for the opportunity to co-promote and to receive a share of the commercial profits in the United States. In all other cases, Medarex will be entitled to receive milestone payments and royalties.

About Lupus

Approximately 350,000 individuals in the United States are affected with lupus, a chronic inflammatory disease that causes the body to attack its own tissues and organs, including the skin, joints, blood and kidneys. Treatments for lupus include anti-inflammatory drugs, antimalarials, corticosteroids and drugs approved for other purposes, such as immunosuppressive agents given to cancer patients undergoing chemotherapy or medicines developed to treat arthritis patients. Lupus occurs about 10 times more frequently in adult females than adult males, and is two to three times more common among African Americans, Hispanics, Asians and Native Americans.

About Medarex

Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb(R) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. More than 40 of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with seven of the most advanced product candidates currently in Phase 3 clinical trials or the subject of regulatory applications for marketing authorization. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its website at http://www.medarex.com.

Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "expect"; "potential" or "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of MEDI-545 in patients, as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and its quarterly reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.

Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of Medarex, Inc. All rights are reserved.


'/>"/>
SOURCE Medarex, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342
2. Medarex to Receive Milestone Payment from Amgen
3. Medarex Announces Ipilimumab Program Continues to Move Forward
4. Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting
5. Medarex Announces Presentations at Annual Meeting of the American Society of Clinical Oncology
6. Medarex Announces Initiation of Phase 2 Clinical Trials for the Treatment of Ulcerative Colitis and Rheumatoid Arthritis
7. Medarex Highlights Strength in Antibody Development and Underlying Pipeline Strategy at R&D Day Event in New York City
8. Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105
9. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
10. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
11. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... Transformational M&A achieved through NPS and Dyax acquisitions and ... M&A achieved through NPS and Dyax acquisitions and the announced ... achieved through NPS and Dyax acquisitions and the announced combination ... most robust pipeline in Shire , s history ... robust pipeline in Shire , s history   ...
(Date:2/11/2016)... --> --> ... report, titled "Sports Medicine Devices Market - Global Industry Analysis, ... to the report, the global sports medicine devices market is ... 2019, growing from a value of US$6.1 bn in 2012 ... --> The global sports medicine devices market is ...
(Date:2/11/2016)... , February 11, 2016 F ast ... answers at the ... world-leading provider of scientific, technical and medical information products and services, has ... evidence-based, peer reviewed clinical information via a mobile device. Elsevier designed the ... for Nursing. The new app is available in Android and ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... 2016 , ... The annual list showcases the 20 Most Promising SharePoint Solution ... dedication and commitment to the SharePoint ecosystem. A panel of experts and members of ... to recognize and promote technology entrepreneurship. , The survey was made at the ...
(Date:2/11/2016)... ... February 11, 2016 , ... Husted Kicking has completed ... CA, on February 6th & 7th, 2016 according to kicking coach Michael Husted. , ... invited to the NFL’s combine in Indianapolis,” says Husted. “The NFL uses a third ...
(Date:2/10/2016)... ... February 10, 2016 , ... President Obama’s ... Advantage organizations to deliver medical services via telehealth, estimated to generate more than ... for such language for many years. Although there is more to be ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... full-service health care communications company offering education, research and medical media, has ... and specialists working in infectious diseases. , As the all-inclusive resource for ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... Academy of Emergency Medicine , an emergency medicine professional association, to support the ... . , The American Academy of Emergency Medicine, or AAEM, seeks to empower ...
Breaking Medicine News(10 mins):