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BIRMINGHAM, Ala., Nov. 23 /PRNewswire-FirstCall/ -- BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it will present at
the Lazard Capital Markets Annual Life Sciences Conference on Wednesday,
November 30, 2005 at 10:00 a.m. Eastern Time at the New York Palace Hotel.
The presentation will be webcast and can be accessed on the companys website
at http://www.biocryst.com.
(Logo: http://www.newscom.com/cgi-bin/prnh/20030414/BIOCRYSTLOGO)
About BioCryst
BioCryst Pharmaceuticals, Inc. designs, optimizes and develops novel drugs
that block key enzymes involved in cancer, cardiovascular diseases, autoimmune
diseases, and viral infections. BioCryst integrates the necessary disciplines
of biology, crystallography, medicinal chemistry and computer modeling to
effectively use structure-based drug design to discover and develop small
molecule pharmaceuticals.
BioCrysts lead product candidate, Fodosine(TM), is a transition-state
analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP).
The drug is currently in a Phase IIa trial for patients with T-cell leukemia
and a combination IV and oral Phase I pharmacokinetic trial in healthy
volunteers. Results of the Phase IIa and the Phase I pharmacokinetic trial
will assist in the design of a planned combination IV and oral Phase IIb
pivotal clinical trial in patients with T-cell leukemia. The Company has
requested a Special Protocol Assessment from the FDA for this planned trial.
Additionally, Fodosine(TM) is currently being studied in a Phase I trial with
an oral formulation in cutaneous T-cell lymphoma (CTCL) and a Phase II trial
in chronic lymphocytic leukemia (CLL). BioCryst also plans to initiate a Phase
I/II trial in B-cell acute lymphoblastic leukemia during 2005. Fodosine(TM)
has been granted Orphan Drug status by the U.S. Food and Drug Administration
for three indications: T-cell non-Hodgkins lymphoma, including CTCL; CLL and
related leukemias including T-cell prolymphocytic leukemia, adult T-cell
leukemia, and hairy cell leukemia; and for treatment of B-cell acute
lymphoblastic leukemia (ALL).
Additionally the FDA has granted "fast track" status to the development of
Fodosine(TM) for the treatment of relapsed or refractory T-cell leukemia. A
Phase Ib study with BioCrysts second-generation PNP inhibitor, BCX-4208, was
recently initiated and is being conducted with the goal of initiating Phase II
studies in patients with psoriasis in 2006. BioCryst has re-initiated clinical
development of peramivir, an inhibitor of influenza neuraminidase, with a
focus on intravenous and intramuscular delivery. Also, BioCryst has identified
a clinical candidate, BCX-4678, in its hepatitis C polymerase inhibitor
program, and is advancing this compound through preclinical testing with the
goal of filing an IND in early 2006. For more information about BioCryst,
please visit the companys web site at http://www.biocryst.com.
Forward-looking statements
These statements involve known and unknown risks, uncertainties and other
factors which may cause our actual results, performance or achievements to be
materially different from any future results, performances or achievements
expressed or implied by the forward-looking statements. These statements
reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these uncertainties,
you should not place undue reliance on these forward-looking statements. Some
of the factors that could affect the forward-looking statements contained
herein include that we may not be able to enroll the required number of
subjects in clinical trials of Fodosine(TM) or BCX-4208, that each of the
Phase IIa trial for patients with T-cell leukemia, Phase I trial of BCX-4208,
the Phase I trial of Fodosine(TM) for treatment of patients with cutaneous T-
cell lymphoma and the Phase II trial of Fodosine(TM) for advanced fludarabine-
refractory CLL may not be successfully completed, that BioCryst may not
commence as expected additional trials with Fodosine(TM) and with BCX-4208 or
planned human trials with peramivir or BCX-4678, that the proposed injectable
formulations of peramivir may not be safe or effective in humans, that
Fodosine(TM), BCX-4208, peramivir, BCX-4678 or any of our other product
candidates may not receive required regulatory clearances from the FDA, that
Phase IIa clinical trials of Fodosine(TM) may not show the drug is effective
over the 6-week period, that ongoing and future clinical trials may not have
positive results, that we may not be able to obtain a Special Protocol
Assessment or otherwise be able to complete successfully the Phase IIb trial
that is currently planned to be pivotal, that we may not be able to continue
future development of Fodosine(TM), BCX-4208, peramivir, BCX-4678 or any of
our other current development programs including tissue factor/factor VIIa,
that Fodosine(TM), BCX-4208, peramivir, BCX-4678 or our other development
programs may never result in future product, license or royalty payments being
received by BioCryst, that BioCryst may not reach favorable agreements with
potential pharmaceutical and biotech partners for further development of its
product candidates, that BioCryst may not have sufficient cash to continue
funding the development, manufacturing, marketing or distribution of its
products and that additional funding, if necessary, may not be available at
all or on terms acceptable to BioCryst. Please refer to the documents BioCryst
files periodically with the Securities and Exchange Commission, specifically
BioCrysts most recent Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, current reports on Form 8-K and the latest Form S-3 which identify
important factors that could cause the actual results to differ materially
from those contained in the projections or forward-looking statements.
Contact:
BioCryst Pharmaceuticals, Inc.
Jonathan M. Nugent
V.P. Corporate Communications
(205) 444-4633
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