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BioCryst Reports Encouraging Test Results on Anticancer Drug

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BlankBioCryst Reports Encouraging Test Results on Anticancer Drug

Birmingham Business Journal - Dec. 11, 2006

Citing " robust " activity, officials with BioCryst Pharmaceuticals Inc. released

today interim results from three clinical studies evaluating the company's

leading anti-cancer compound, Fodosine.

The trademarked compound is being developed for the treatment of certain types

of leukemias and lymphomas. Data will be presented formally during the 2006

American Society of Hematology Annual Meeting in Orlando, Fla., on Sunday.

Birmingham-based BioCryst (NASDAQ: BCRX) develops drugs that block key enzymes

involved in cancer, cardiovascular and autoimmune diseases, and viral

infections.

Midstudy results of a Phase I/II trial involving the oral formulation of the

drug evaluated 34 patients with refractory cutaneous T-cell lymphoma. The

overall response rate for these patients was 50 percent, including three

patients, or 8.8 percent, with complete responses and 14 patients, or 41

percent, with partial responses.

The study concluded that in addition to a good safety profile, Fodosine

demonstrated clinical activity as a single oral agent in patients with advanced

stages of the lymphoma. BioCryst plans to initiate a Phase II study.

Bugg, BioCryst's chairman and CEO, said the " encouraging " results

" validate the potential importance of Fodosine as a single agent therapy for the

treatment of patients with certain types of leukemias and lymphomas. "

" We believe that with its robust clinical activity and positive safety profile,

Fodosine may be an important addition to the range of treatments available to

hematologists and oncologists, " Bugg said in a news release announcing the

results.

Data presented from a Phase II study of Fodosine in the treatment of patients

with clinically active relapsed/refractory T-cell leukemia exhibited promise as

well.

Of the 50 patients involved in that trial, nine, or 18 percent, exhibited a

complete response. More promising, however, was the restoration of normal blood

cell development observed during treatment, indicating the drug's potential for

use as a targeted, less toxic therapy to treat the condition.

In turn, Bugg said the company plans to initiate a " pivotal " Phase IIb study.

The third study presented data indicating Fodosine is a safe, well-tolerated

drug with preliminary evidence of activity as a single agent in patients with

relapsed or refractory B-lineage acute lymphoblastic leukemia.

Said Bugg: " We believe Fodosine has the potential to play a valuable role in the

treatment of patients with T-cell and B-cell mediated diseases and we look

forward to the continued clinical study of Fodosine. "

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