BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today reported interim results from
three clinical studies evaluating the company's lead anti-cancer compound,
Fodosine(TM) which is being developed for the treatment of certain types of
leukemias and lymphomas. The data were presented Sunday, December 10, 2006
during the 2006 American Society of Hematology Annual Meeting in Orlando,
Florida.
Among the presentations was a poster entitled, "Oral Forodesine
(BCX-1777) is Clinically Active in Refractory Cutaneous T-Cell Lymphoma:
Results of a Phase I/II Study," by Madeleine Duvic et al. This Phase I/II
multi-center trial of oral Fodosine(TM) evaluated 34 patients with
refractory cutaneous T-cell lymphoma (CTCL). The overall response rate for
these patients was 50%, including three patients with complete response
(8.8%) and 14 patients with partial response (41%). Improvement in SWAT
scores was observed in patients while on therapy and erythroderma was
improved in the majority of patients treated with Fodosine(TM). The study
concluded that in addition to a good safety profile, Fodosine(TM)
demonstrated clinical activity as a single oral agent in patients with
advanced refractory CTCL. Based on these encouraging results, the company
plans to initiate a Phase II study of Fodosine(TM) in CTCL.
"These encouraging results validate the potential importance of
Fodosine(TM) as a single agent therapy for the treatment of patients with
certain types of leukemias and lymphomas," said Charles E. Bugg, Ph.D.,
Chairman and CEO of BioCryst. "We believe that with its robust clinical
activity and positive safety profile, Fodosine(TM) may be an important
addition to the range of treatments available to hematologists and
oncologists."
Additionally, data were presented from a Phase II study of Fodosine(TM)
in the treatment of patients with clinically active relapsed/refractory
T-cell leukemia (T-ALL). Richard Furman, M.D., presented the poster,
"Forodesine IV (BCX-1777) Is Clinically Active in Relapsed/Refractory
T-Cell Leukemia: Results of a Phase II Study." In this multicenter Phase II
clinical trial, 50 patients with relapsed/refractory T-cell acute
lymphoblastic leukemia (T-ALL) were treated. Of those 50 patients, nine
exhibited a complete response (18%). Additionally, restoration of normal
hematopoiesis was observed during treatment reaffirming the specificity of
Fodosine(TM) for leukemia cell populations and indicating the drug's
potential for use as a targeted, less- toxic therapy to treat T-ALL.
"The Phase II study of Fodosine(TM) in the treatment of patients with
relapsed/refractory T-ALL concluded that IV Fodosine(TM) is safe, well
tolerated and effective as a single agent therapy. Based of these positive
data, we plan to initiate a pivotal Phase IIb study in patients with
T-ALL," said Dr. Bugg.
Data from a third study were presented by Ellen Ritchie, M.D. The
poster, entitled "Phase II Study of Forodesine, a PNP Inhibitor, in
Patients With Relapsed or Refractory B-Lineage Acute Lymphoblastic
Leukemia," contained interim information from a multicenter Phase II trial
designed to determine the safety, efficacy and pharmacokinetic and
pharmacodynamic characteristics of repeat doses of IV Fodosine(TM) in
patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL). The data
presented indicate that Fodosine(TM) is a safe, well-tolerated drug with
preliminary evidence of activity as a single agent in B-ALL.
"We believe Fodosine(TM) 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(TM)," said Dr.
Bugg.
About BioCryst
BioCryst Pharmaceuticals, Inc. is a leader in the use of
crystallography and structure-based drug design for the development of
novel therapeutics to treat cancer, cardiovascular diseases, autoimmune
diseases, and viral infections. The Company is advancing multiple internal
programs toward potential commercialization including Fodosine(TM) in
oncology, BCX-4208 in transplantation and autoimmune diseases, peramivir in
seasonal and life- threatening influenza and BCX-4678 in hepatitis C.
BioCryst has a worldwide partnership with Roche for the development and
commercialization BCX-4208 and is collaborating with Mundipharma Holdings
for the development and commercialization of Fodosine(TM) in markets across
Europe, Asia, Australia and certain neighboring countries. For more
information about BioCryst, please visit the Company's web site at
biocryst.
Forward-looking statements
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. 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 or our licensees may not be
able to enroll the required number of subjects in planned clinical trials
of our product candidates and that such clinical trials may not be
successfully completed, that BioCryst or its licensees may not commence as
expected additional human clinical trials with our product candidates, that
our product candidates may not receive required regulatory clearances from
the FDA, that ongoing and future clinical trials may not have positive
results, that we may not be able to complete successfully the Phase IIb
trial for Fodosine(TM) pursuant to the Special Protocol Assessment letter
that is currently planned to be pivotal, that we or our licensees may not
be able to continue future development of our current and future
development programs, that our 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 or governmental agencies 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,
and the risks, uncertainties and factors identified in the documents
BioCryst files periodically with the Securities and Exchange Commission,
specifically including BioCryst's most recent Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, current reports on Form 8-K. These
statements reflect our current views with respect to future events and
BioCryst has no obligation to update or revise the statements. BioCryst
cautions that you should not place undue reliance on these forward-looking
statements.
BioCryst Pharmaceuticals, Inc.
biocryst