Navigation Links
Medarex Announces Initiation of Phase 1b Clinical Development Program with MDX-1106 for the Treatment of Cancer
Date:11/24/2008

PRINCETON, N.J., Nov. 24 /PRNewswire-FirstCall/ --Medarex, Inc. (Nasdaq: MEDX) today announced it has initiated a Phase 1b clinical trial for MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody for the treatment of cancer. Studies suggest that the PD-1 signaling pathway may play an important role in tumor evasion and escape from host immune responses and may also promote the persistence of certain chronic viral infections.

The Phase 1b clinical trial is designed to primarily evaluate the safety and tolerability of repeated dosing of MDX-1106 in adult patients with solid tumors and will also provide a preliminary assessment of the anti-tumor activity of multiple doses of MDX-1106 (1, 3 or 10 mg/kg) in these patients. The tumors to be studied include malignant melanoma, renal cell cancer, castrate-resistant prostate cancer and non-small cell lung carcinoma. This open label study is expected to enroll up to 76 patients and will be conducted in multiple sites in the United States.

"We believe that anti-PD-1 antibodies could represent the next stage in immunotherapy with a promising mechanism of action and potential for marked synergy with anti-CTLA4 antibodies," said Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at Medarex. "Preliminary results from our single-dose Phase 1 study demonstrated an acceptable safety profile and initial evidence of anti-tumor activity in cancer. We look forward to the further development of this novel immunotherapy in cancer and, in a separate clinical trial, hepatitis C."

In May 2005, Ono entered into a collaboration agreement with Medarex to research and develop a fully human anti-PD-1 antibody for the treatment of cancer. The two companies plan to share the costs and responsibilities of research and product development up to the completion of a Phase 2 clinical study in each party's territory. Thereafter, each company will be fully responsible for any continued development and any commercialization in its exclusive territory; Medarex's exclusive territory is North America, and Ono's exclusive territory is all areas outside of North America.

About MDX-1106/ONO-4538

MDX-1106/ONO-4538 is a novel fully human antibody designed to target and inhibit the function of PD-1 (programmed cell death 1), a receptor expressed on the surface of activated lymphocytes (T-cells). The binding of PD-1 with one of two ligands (PD-L1 or PD-L2) is an important negative regulation pathway that suppresses or inhibits activated lymphocytes. Recent research has noted increased PD-1 expression levels on antigen specific T-cells in both the oncology and chronic infectious disease settings, as well as a strong correlation between increased PD-L1 expression on tumors and a negative survival prognosis in cancer patients. Preclinical studies indicate that antibodies targeting the PD-1 signaling pathway reinvigorate antigen-specific T-cell responses and promote an immune response to fight tumors and infectious diseases.

As previously presented at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO), interim Phase 1 data in patients with recurrent or treatment-refractory cancer indicated preliminary evidence of anti-tumor activity or tumor regression in patients with recurrent or treatment-refractory cancer, as well as a favorable safety, tolerability and pharmacokinetic profile of single-dose MDX-1106. Data from the completed Phase 1 study are expected to be presented at an upcoming medical meeting.

MDX-1106/ONO-4538 is being investigated in both the oncology and infectious disease settings. In addition to the Phase 1b study in cancer, a Phase 1 trial is ongoing for the treatment of hepatitis C. In September 2008, Ono filed an IND to allow the initiation of a single and multi-dose Phase 1 clinical study in patients with advanced solid malignancies in Japan. MDX-1106/ONO-4538 may also have the potential to be used synergistically in combination with other treatment modalities, including with anti-CTLA-4 blockade.

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. Over forty of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with 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 www.medarex.com .

Medarex Statement on Cautionary Factors

Except for the historical information presented herein, the statements relating to MDX-1106 in this press release 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. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with product discovery and development of MDX-1106, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of antibody products in patients, uncertainties related to product manufacturing, 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 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. Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus
10. Medarex Announces Presentations at the 33rd Congress of the European Society for Medical Oncology
11. Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... Digital Health Dialog, LLC dba EngagedMedia ... US Patent and Trademark Office of U.S. Patent ... for electronic opt-­in and processing of discount coupons ... compliance and otherwise. Logo - http://photos.prnewswire.com/prnh/20160524/371583LOGO ... "Our technology allows for individuals to opt­-in to ...
(Date:5/24/2016)... , May 24, 2016 ... Markt gebracht, die es Ärzten erlaubt, ihre Expertise ... behandeln: MDLinking kombiniert Live Streaming mit einer Instant-Messaging-Funktion ... zu kommunizieren. Mediziner in Europa, Afrika, Asien und ... bereits für die Plattform registriert. Information ...
(Date:5/24/2016)... HENDERSON, Nev. , May 24, 2016  Diana ... painfully "eats" her organs from the inside out.  This ... her completely dependent on her children and grandchildren to ... of her wheelchair, Diana,s family cannot haul the wheelchair.  ... rides in the car, and Diana is left to ...
Breaking Medicine Technology:
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... ... in scholarships to students studying complementary medicine. Allison Outerbridge is this year’s ... her award on May 18 at the university’s Student Leadership Awards ceremony. , ...
(Date:5/26/2016)... ... May 26, 2016 , ... There are many ways to cook a hot ... suggests that Americans prefer their dogs straight off the grill. Of the 90 percent ... favorite way to cook a hot dog, far outpacing other cooking methods such as ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... and clinical outcomes, hosted members and suppliers for its inaugural Member Conference at ... on their mission of elevating the operational health of America’s healthcare providers. , ...
(Date:5/26/2016)... ... May 26, 2016 , ... On Memorial Day, Hope ... lost their lives in military battle for the country. The nonprofit Hope For ... provide more programs that empower independence for disabled military veterans, as well as police, ...
(Date:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million people living with ... worldwide. On Sunday, June 5, 2016, communities around the world will gather to recognize ... , National Cancer Survivors Day® is an annual worldwide Celebration of Life that is ...
Breaking Medicine News(10 mins):