Navigation Links
Onconova announces FDA agreement of a SPA for a pivotal phase 3 trial of Estybon in MDS
Date:10/4/2010

Newtown, PA, October 4, 2010 Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow. The SPA provides FDA evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints and data analysis, and provides further agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.

The Estybon MDS trial will be conducted by Onconova in the U.S. and Europe and will enroll patients with excess blasts who are resistant or intolerant to or have relapsed after treatment with currently approved treatments. The Onconova trial will compare the efficacy and safety of Estybon to Best Supportive Care (BSC). Patient enrollment in the U.S. is expected to begin in 4Q 2010. Ongoing studies of Estybon have enrolled a broad range of MDS patients with various cytogenetic markers and classifications. Results from these MDS trials, including survival data will be presented at the annual meeting of the American Society of Hematology (ASH) in December 2010 in Orlando, FL.

James F. Holland, M.D., Distinguished Professor of Neoplastic Diseases at Mount Sinai School of Medicine and Onconova Clinical Advisory Board member, a Lasker award recipient, commented: "More active agents are needed to improve survival for patients with MDS. We are very excited about this Phase 3 trial, which is based on the encouraging Phase 2 data. The activity of ON 01910.Na is remarkable as a single agent and when combined with other chemotherapeutic agents. These promising results could prove beneficial in multiple cancer indications."

"Securing the SPA for Estybon in MDS is an important step in the development of this innovative therapy for cancer patients," said Michael Hoffman, Chairman, Board of Directors of Onconova. "We are optimistic that the strikingly positive results from ongoing trials, combined with the anticipated data from this registration trial, will help establish the utility of Estybon in this patient population, presently facing limited treatment options. We are also pursuing solid tumor indications for Estybon which is broadly active in a variety of tumor types."

Dr. Francois Wilhelm, Chief Medical Officer of Onconova added, "The Phase 1 and 2 Estybon data which were presented at the Best of ASH session of the 2009 ASH conference, demonstrated promising activity and outcomes for MDS patients treated with Estybon and provided heightened awareness of the potential therapeutic role of a Cyclin D targeted therapy for these patients."

"The Leukemia & Lymphoma Society (LLS) is committed to the rapid advancement of therapies that have strong potential for the treatment of patients with MDS" said Louis J. DeGennaro, LLS Chief Mission Officer. "LLS continues its support for the development of Estybon through our collaboration with Onconova announced in June 2010. We see this SPA as a significant step toward making this drug available to patients. "


'/>"/>

Contact: Kathryn Morris
kathryn@proncall.com
845-635-9828
PR on Call
Source:Eurekalert

Related biology news :

1. NIAID announces 25 new awards to develop radiation countermeasures
2. Aware Announces Q3 2008 Earnings Conference Call
3. Governor Doyle announces historic genomic research collaboration
4. BIO-key(R) Announces Additional $245,000 in Third Quarter Public Safety Orders
5. NARSAD announces 2008 Prizes for Outstanding Achievement in Research on Mental Health Disorders
6. Parkinsons Disease Foundation announces award of $150,000
7. Jefferson Department of Surgery announces new pancreas tumor registry
8. NAS announces initiative to connect entertainment industry with top experts
9. Elsevier announces winners of 3rd Annual Scopus Young Indian Scientist Award
10. VUANCE Announces Crime Scene Security and Evidentiary Tracking Development Project
11. WCC Announces Version 6 of its ELISE Smart Search and Match Platform for Employment and Biometric Matching
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/30/2017)... June 30, 2017 Today, American Trucking ... supplier of face and eye tracking software, became ... provider program. "Artificial intelligence and ... to monitor a driver,s attentiveness levels while on ... able to detect fatigue and prevent potential accidents, ...
(Date:5/16/2017)... , May 16, 2017  Veratad Technologies, LLC ( ... online age and identity verification solutions, announced today they ... Conference 2017, May 15 thru May 17, 2017, in ... and International Trade Center. Identity impacts ... and in today,s quickly evolving digital world, defining identity ...
(Date:4/19/2017)... ALBANY, New York , April 19, 2017 /PRNewswire/ ... highly competitive, as its vendor landscape is marked by ... in the market is however held by five major ... and Safran. Together these companies accounted for nearly 61% ... majority of the leading companies in the global military ...
Breaking Biology News(10 mins):
(Date:10/10/2017)... ... October 10, 2017 , ... ... targeted antibody-drug conjugate (ADC) therapeutics, today confirmed licensing rights that give it ... Nanoparticle), a technology developed in collaboration with Children’s Hospital Los Angeles (CHLA). ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... optimization firm for the life sciences and healthcare industries, announces a presentation by ... Francisco. , The presentation, “Automating GxP Validation for Agile Cloud Platforms,” will present ...
(Date:10/9/2017)... ... October 09, 2017 , ... The Giving Tree ... products targeting the needs of consumers who are incorporating medical marijuana into their ... Phoenix, Arizona. , As operators of two successful Valley dispensaries, The Giving Tree’s ...
(Date:10/6/2017)... Mass. (PRWEB) , ... October 06, 2017 , ... ... female entrepreneurship within the healthcare and technology sector at their fourth annual Conference ... panels featuring 30 inspiring speakers and the ELEVATE pitch competition showcasing early stage ...
Breaking Biology Technology: