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 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.
Charles 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."
What's big here is that the drug is oral. That is a HUGE advantage over other chemotherapy drugs. Also, it specifically targets T cell enzymes---less side effects and it appears to be reversible.
Fodosine works by a rather novel mechanism of action. It is a purine nucleoside phosphorylase (PNP)inhibitor and altered levels of the enzyme causes T-cell immunodeficiency. The enzyme is therefore a target for autoimmunity disorders, tissue transplant rejection and T-cell malignancies (cancers).
Again, this will have a very large impact on the market and the company if the oral formulation proves efficacious against T cell lymphoma.
NASDAQ: BCRX: The data must not have impressed investors as much as I'm impressed. BCRX is trading down 14 cents today.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment