Navigation Links
Agensys, an Affiliate of Astellas, Announces Initiation of Phase I Clinical Trial of AGS-16M8F for Renal Cancer
Date:9/1/2010

SANTA MONICA, Calif., Sept. 1 /PRNewswire/ -- Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing.

"Despite the availability of several therapies for the treatment of metastatic renal cancer, there is a significant need for new renal cancer therapies," said Leonard Reyno, M.D., Senior Vice President and Chief Medical Officer at Agensys. "We believe AGS-16M8F, which is an ADC designed to deliver the potent cytotoxic agent MMAF directly to tumor cells, has the potential to provide a new therapeutic option for this disease."

The single-agent, Phase I, open-label, dose-escalation study will evaluate the safety and tolerability of AGS-16M8F in patients with renal cancer and identify the maximum tolerated dose. Secondary objectives include assessing the pharmacokinetics and antitumor activity of AGS-16M8F and identifying a recommended dose and regimen for future clinical trials. The study is designed to enroll approximately 50 patients at multiple centers in the United States.

Dr. David Stover, Vice President and Head of Research at Agensys, noted that AGS-16M8F is an ADC composed of a fully human monoclonal antibody directed to ectonucleotide pyrophosphatase/phosphodiesterase 3 (ENPP3), a novel cancer target identified by Agensys to be upregulated in the majority of renal cancers.

The antibody is attached to a highly potent, synthetic agent, monomethyl auristatin F (MMAF), via a non-cleavable linker using Seattle Genetics' proprietary technology. The novel linker system is designed to be stable in the bloodstream and release the potent cell-killing agent once inside antigen-expressing cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity.

About Renal Cancer

The American Cancer Society estimates there to be more than 58,000 new cases of renal cancer and more than 13,000 are expected to die from the disease in the United States in 2010. Overall, the lifetime risk of getting renal cancer is about 1 in 70. This risk is higher in men than in women. Renal cancer is the 9th leading cause of cancer-related death for both men and women. The 5-year survival rates for people diagnosed with any stage of renal cancer is 68 percent.

About Agensys

Agensys, Inc., an affiliate of Astellas Pharma Inc., is developing a pipeline of therapeutic fully human monoclonal antibodies (MAbs) to treat cancers. The MAb product pipeline is based on Agensys' diverse portfolio of proprietary, clinically relevant cancer targets. Agensys' target portfolio and related products are protected by a large patent estate. The Company has full capabilities to generate, develop and manufacture antibody products. Agensys is progressing a pipeline of both naked and antibody-drug conjugated (ADC) therapeutic antibodies, directed at a variety of cancer indications, including those of the prostate, kidney, pancreas, ovary, bladder, lung, colon, breast and skin. ADC products are based on drug platform technologies developed by Seattle Genetics. Agensys is developing a growing pipeline of clinical stage functional MAbs and ADC products.

About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader by rapidly establishing a business model in urology, immunology & infectious diseases, neuroscience, DM complications & metabolic diseases and oncology. Astellas has discovered a treatment for over-active bladder (OAB), Vesicare® (solifenacin succinate) and an immunosuppressant, Prograf® (tacrolimus), which have enabled Astellas to become an established leader in both Urology and Transplant. For more information on Astellas Pharma Inc., please visit Astellas' website at http://www.astellas.com/en.


'/>"/>
SOURCE Astellas Pharma Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. UCI Medical Affiliates, Inc. Reports Third Quarter Results for Fiscal Year 2010
2. Kendle is First Global CRO to Achieve ISO 9001:2008 Certification in China Through Beijing Affiliate
3. US Oncology Ranks 2nd in Affiliate Member Accruals for Radiation Therapy Oncology Group
4. Surgical Care Affiliates Announces Investor Conference Call to Discuss 2009 Third Quarter Results
5. Access Licenses ProLindac(TM) and MuGard(TM) to JCOM Ltd, an Affiliate of DONG-A Pharmaceuticals in Korea
6. TargeGen Affiliates Scheduled for Oral Presentation of Interim Clinical Trial Data at 2008 ASH Meeting in San Francisco for TG101348, a Potent, Selective, Oral JAK2 Inhibitor in Myeloproliferative Disease Patients
7. US Oncology Affiliated Physicians Make a Strong Showing in ASCO Proceedings
8. Parker Waichman Alonso LLP and Affiliated Lawfirms Have Filed a Class Action Lawsuit in the United States District Court for the Eastern District of New York Against Merck & Co., Inc. and Schering-Plough Corporation
9. Emerging Agents from Theravance/Astellas, Johnson & Johnson/Basilea and Forest/Astrazeneca/Takeda Will Drive Modest Growth in the MRSA Drug Market Through 2018
10. Golden Meditech Announces Plan to Issue Taiwan Depository Receipts
11. Accuray Announces Results for Fourth Quarter and Fiscal Year 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016 The Academy of Managed Care Pharmacy ... that would allow biopharmaceutical companies to more easily share ... formulary and coverage decisions, a move that addresses the ... The recommendations address restrictions in the sharing ... drug label, a prohibition that hinders decision makers from ...
(Date:6/24/2016)... 2016 Research and Markets has announced ... Diagnostic Tests" report to their offering. ... The World Market for Companion Diagnostics covers ... Market analysis in the report includes the following: ... Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... today announced the appointment of Dr. Edward ... as a Non-Executive Director, effective June 23, 2016.Dr. ... Compensation and Nominations and Governance Committees.  As a ... will provide independent expertise and strategic counsel to ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... ... TopConsumerReviews.com recently awarded their highest five-star rating to Best Buy Eyeglasses, an ... United States and Canada wear eyeglasses. Once considered to be a purely functional part ... fashion statement. Even celebrities use glasses as a way of creating an iconic image—like ...
(Date:6/26/2016)... ... , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a ... fitness app plans to fix the two major problems leading the fitness industry today:, ... type program , They don’t eliminate all the reasons people quit their exercise ...
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the ... In terms of the latter, setting the bar too high can result in disappointment, ... just slow progress toward their goal. , Research from PsychTests.com reveals ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
Breaking Medicine News(10 mins):