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:4/28/2017)... ... ... Hawkins, Pastor and Overseer at The House of Yahweh in Abilene, Texas, has published a ... does not. Yisrayl says with so many titles and names for the Creator, it’s ... with a little Scripture, backed with a lot of research, the truth is undeniable. ...
(Date:4/28/2017)... ... April 28, 2017 , ... ... North East region. Côté has 20+ years of experience within the beauty industry, ... worked with an array of high-end cosmetic brands, retail brands and outlets in ...
(Date:4/28/2017)... York, New York (PRWEB) , ... April 28, ... ... high-quality anti-aging skincare and advanced nutraceutical supplements, through its Nova Skin ... cream provides the hydrating benefits of a moisturizer with the power of an ...
(Date:4/28/2017)... ... April 28, 2017 , ... Rob Lowe is a popular actor that ... his presence to an educational purpose as the host of the “Informed” series. The ... In a recent episode, the series focuses on thyroid cancer. , Although thyroid cancer ...
(Date:4/28/2017)... , ... April 28, 2017 , ... Christie Medical ... announced an alliance with B. Braun Medical Inc. , a leader in infusion ... patient care with as many as 90 percent of hospital patients receiving a peripheral ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... Research and Markets has announced the ... Market Analysis By Service (Manufacturing, Research), By Country, (Brazil, Mexico, ... report to their offering. ... The Latin American pharmaceutical contract manufacturing services market ... Low drug registration cost in Latin American countries and ...
(Date:4/19/2017)... , April 19, 2017 The Mobile X-Ray product ... a healthy CAGR during the forecast period Mobile ... the global digital mobile X-Ray devices market, which is estimated ... 2017, expanding at a CAGR of 7% over the forecast ... opportunity of more than US$ 100 Mn in 2017 over ...
(Date:4/19/2017)... 19, 2017 Global Prostate Cancer Therapeutics ... the prostate cancer therapeutics market analyzes the current ... prevalence of prostate cancer, launch of promising emerging ... of new drugs & therapeutic biological products, and ... to lesser side effects are some of the ...
Breaking Medicine Technology: