BioCryst Pharmaceuticals Inc. shares gained ground Monday after the company said it will be advised by the Food and Drug Administration on the design of a clinical trial for its cancer drug Fodosine.
Fodosine will be tested on patients with cutaneous T-cell lymphoma, or CTCL, a rare cancer of the lymph nodes that causes tumors and patches on the skin. The subjects will be patients whose disease remains, or is progressing, despite repeated therapies.
The main goal of the study is to improve patients' skin, with secondary goals of showing the drug is safe and effective, and determining how long the effects last. BioCryst said it will begin enrolling patients during the third quarter.
Leerink Swann analyst Joseph Schwartz said the agreement, called a special protocol assessment, reduces the risks involved in developing the drug because BioCryst and the FDA have already agreed on how the trial will be conducted, and what will be considered proof that the drug works.
The trial has been designated "pivotal," he said, meaning approval could come quickly.
"Even though it's a Phase II trial, it's such an unmet medical need that in many cases _ especially in cancer _ drugs can be gotten to market after a Phase II," Schwartz said.
The analyst believes the drug will be approved in mid-2010, and expects sales will peak at about $250 million in 2015.
Fodosine is also being tested in chronic lymphocytic leukemia, or CLL, and B-cell acute lymphoblastic leukemia, or B-ALL.
Schwartz said about 1,000 new cases of CTCL are diagnosed in the U.S. each year. About 10,000 cases of CLL diagnosed in the country annually, along with 4,000 cases of B-ALL.
The Birmingham, Ala.-based company has formed a partnership with Roche to develop a similar drug, called BCX-4208, which is designed to treat transplant rejection and autoimmune disorders including psoriasis.
BioCryst shares rose 48 cents, or 6.1 percent, to $8.30 in afternoon trading. The stock has ranged from $6.57 to $14.69 in the past year.
____________
Questions or comments about this story should be directed to the Financial News desk of The Associated Press at (212) 621-7190.