Navigation Links
Onconova announces FDA agreement of a SPA for a pivotal phase 3 trial of Estybon in MDS

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
PR on Call

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:
(Date:11/18/2015)... , Nov. 18, 2015  As new scientific ... children, doctors and other healthcare providers face challenges in ... families and patients. In addition, as more children continue ... a patient,s adulthood and old age. John ... The Children,s Hospital of Philadelphia (CHOP) . ...
(Date:11/17/2015)... , November 17, 2015 ... 19 novembre  2015.  --> Paris , ... --> DERMALOG, le leader de l,innovation biométrique, a ... fois passeports et empreintes sur la même surface de ... passeports et l,autre pour les empreintes digitales. Désormais, un ...
(Date:11/16/2015)... , Nov 16, 2015  Synaptics Inc. ... human interface solutions, today announced expansion of its ... ™ touch controller and display driver integration ... of smartphones. These new TDDI products add to ... (HD resolution), TD4302 (WQHD resolution), and TD4322 (FHD ...
Breaking Biology News(10 mins):
(Date:12/1/2015)... 2015  Symic, a clinical-stage biotherapeutics company developing multiple ... today announced that it has secured $25 million in ... including its lead candidates SB-030 and SB-061. The financing ... by all existing major investors, as well as several ... raised by Symic to over $43 million since being ...
(Date:12/1/2015)... ) has ... Virology and Bacteriology Testing Market: Sales and ... Shares by Test, Innovative Technologies, Competitive Strategies, ... --> ) has announced the ... Bacteriology Testing Market: Sales and Volume Segment ...
(Date:11/30/2015)... -- An interventional radiology technique shows promise for helping morbidly obese ... study being presented today at the annual meeting of the ... --> --> Gastric ... as a way to stop bleeding in emergency situations, but ... treating obesity is new. Mubin Syed , M.D., ...
(Date:11/30/2015)... Nov. 30, 2015 /PRNewswire/ - Zenith Epigenetics Corp. ("Zenith" or ... Norman C.W. Wong to its Board of Directors to ... Zenith with a wealth of experience as co-founder of Resverlogix, ... --> --> Dr. Wong ... board of directors. Zenith,s long standing expertise in epigenetics and ...
Breaking Biology Technology: