Navigation Links
BioCryst Receives Special Protocol Assessment for Fodosine

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the FDA's Special Protocol Assessment (SPA) process for the design of its planned pivotal clinical trial of the oral formulation of the company's lead oncology compound, Fodosine(TM) (forodesine hydrochloride) in patients with cutaneous T-cell lymphoma.

A Special Protocol Assessment is a request for feedback from the FDA that allows a company to receive official evaluation and guidance on the design of pivotal trial protocols. BioCryst requested the formal assessment, late in the first quarter of 2007, because the pivotal trial is intended to form the primary basis of an efficacy claim in the planned new drug application (NDA) for oral Fodosine.

The multicenter, multinational, open-label, single-arm, repeat-dose pivotal trial is expected to initiate enrollment during the third quarter of 2007. The trial will enroll patients with CTCL of Stage IB through Stage IVA who have disease that is persistent, progressive or recurrent during or after treatment with at least three systemic therapies. The study's primary endpoint is to determine the objective response rate, defined as either complete response or partial cutaneous response, achieved with a once-daily oral regimen of Fodosine(TM). Secondary endpoints include assessing the safety and tolerability of extended daily treatment with oral Fodosine(TM), assessment of the time to objective response and the duration of objective response.

"We are pleased to have reached agreement with the FDA in a timely manner. Receipt of this SPA is an important milestone in the development of Fodosine(TM) and a sign of our commitment to deliver on our goals," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "We would like to thank the FDA for their input and guidance during this SPA process. BioCryst is now well positioned to begin pati ent enrollment during the third quarter."


'"/>




Related medicine news :

1. BioCryst’s Bird Flu Drug Enjoys Fast-Track Review By FD
2. Fifth US Patient Receives Artificial Heart
3. Northfield Labs Receives FDA Comments
4. British MPs Say Prostate Cancer Receives Low Priority in the NHS
5. Abbott Receives CE Mark Certification
6. Zactima Receives Fast Track Designation By The FDA
7. East London Receives World Class New Private Hospital Facility
8. Brinda Karat Receives Legal Notice over Ramdev Issue
9. Quake-Hit Pakistan Receives 30 Field Hospitals From Cuba
10. Medtronic’s Insulin Pump Receives Regulatory Approva
11. Aurobindo Receives Approval from USFDA for anti-AIDS drug
Post Your Comments:
*Name:
*Comment:
*Email:


(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)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda ... orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including ... accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)...  Collagen Matrix, Inc., ("Collagen Matrix") the driving ... collagen and mineral based medical devices for tissue ... Messer has joined the company as Vice ... growing portfolio of oral surgery, neurosurgery, orthopaedic and ... the Collagen Matrix executive team as an accomplished ...
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
(Date:6/24/2016)... --  Pulmatrix, Inc ., (NASDAQ: PULM ), ... today that it was added to the Russell Microcap ... set of U.S. and global equity indexes on June ... for Pulmatrix," said Chief Executive Officer Robert Clarke ... in developing drugs for crucial unmet medical needs, and ...
Breaking Medicine Technology: