Navigation Links
Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105
Date:8/5/2008

Clinical study planned for advanced or recurrent solid tumors

PRINCETON, N.J., Aug. 5 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1105, for the treatment of patients with selected advanced or recurrent solid tumors, specifically renal cell carcinoma, melanoma, non-small cell lung cancer or epithelial ovarian cancer. MDX-1105 is a fully human antibody that targets the PD-L1 pathway to promote enhanced T-cell immune responses against cancer and reverse T-cell inactivation in chronic infectious disease.

The open-label, multi-dose, dose-escalation Phase 1 clinical trial is expected to enroll up to 46 patients with selected advanced or recurrent solid tumors. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary pharmacodynamics and efficacy, of MDX-1105.

"We are pleased that another product candidate from our proprietary pipeline has progressed into clinical trials," said Howard H. Pien, President and CEO of Medarex. "We believe that our fully human anti-PD-1 and anti-PD-L1 antibodies represent the next stage in immunotherapy beyond the anti-CTLA-4 antibodies. We look forward to exploring the potential of MDX-1105 as a possible new treatment option for patients with cancer and infectious disease."

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.

Medarex 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 "expected"; "potential"; "possible"; or "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. These risks and uncertainties include those 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. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
9. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... , Feb. 12 2016  OMS Supply, a large ... medical practitioners, announced today the recent launching of their ... a variety of features that enhance the user experience ... supplies. --> --> ... fairly new company that started in early 2016, they ...
(Date:2/12/2016)... Maharashtra, February 12, 2016 ... report titled Chronic Inflammation Global Clinical Trials Review, ... of the global clinical trials landscape along with ... by Region, Country (G7 & E7), Trial Status, ... and reviews top companies involved and enlists all ...
(Date:2/11/2016)... IRVINE, Calif., Feb. 11, 2016 PRO-DEX, INC. (NasdaqCM: ... quarter ended December 31, 2015. The Company also filed its ... fiscal year 2016 with the Securities and Exchange Commission today. ... December 31, 2015 --> --> ... 2015 increased $2.6 million, or 95%, to $5.4 million from ...
Breaking Medicine Technology:
(Date:2/12/2016)... , ... February 12, 2016 , ... Every winter, someone ... This winter the West Penn Burn Center, part of the Allegheny Health ... to bring you the “Space Heaters Need Space” campaign. , “Space ...
(Date:2/12/2016)... ... 12, 2016 , ... AssureVest Insurance Group, a locally owned insurance firm with ... will raise funds earmarked to purchase computers and software for Mrs. Harrison’s 2nd and ... is in a low-income area and has more than 60 2nd and 3rd graders ...
(Date:2/12/2016)... ... ... Vail knee specialist Robert LaPrade, MD, PhD was named one ... consists of physicians establishing, leading and partnering with ambulatory surgery centers across the United ... Center, also known as an ASC, is a modern health care facility focused on ...
(Date:2/12/2016)... ... February 12, 2016 , ... Young Asset Protection, a full ... of the latest charity campaign in their community enrichment program. Art Expression utilizes ... worthy cause are currently being accepted at: http://artexpressioninc.org/ . , Art Expression ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... Miami Dental ... implants to their Miami dental office. Beginning in January, Miami Dental Specialists will ... Miami Dental Specialists are the first office to be chosen by the dental implant ...
Breaking Medicine News(10 mins):