SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: March 31, 2004
BioCryst Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware 000-23186 62-1413174
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification #)
2190 Parkway Lake Drive, Birmingham, Alabama 35244
(Address of Principal Executive Office)
(205) 444-4600
(Registrant's telephone number, including area code)
Item 5. Other Events and Regulation FD Disclosure.
On March 31, 2004, Registrant issued a press release announcing the
initiation of a Phase II clinical trial of BCX-1777 in T-cell leukemia. The
press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K.
Neither the filing of any press release as an exhibit to this Current
Report on Form 8-K nor the inclusion in such press release of a reference to
Registrant's Internet address shall, under any circumstances, be deemed to
incorporate the information available at such Internet address into this Current
Report on Form 8-K. The information available at Registrant's Internet address
is not part of this Current Report on Form 8-K or any other report filed by
Registrant with the Securities and Exchange Commission.
Item 7. Exhibits.
Exhibit No. Description
99.1 Press release dated March 31, 2004 entitled "BioCryst
Pharmaceuticals Initiates Phase II Clinical Trial of BCX-1777
in T-Cell Leukemia".
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: March 31, 2004 BioCryst Pharmaceuticals, Inc.
By: /s/ Michael A. Darwin
-------------------------
Michael A. Darwin
Chief Financial Officer and Chief
Accounting Officer
EXHIBIT INDEX
Item Description
99.1 Press release dated March 31, 2004 entitled "BioCryst
Pharmaceuticals Initiates Phase II Clinical Trial of BCX-1777
in T-Cell Leukemia".
Exhibit 99.1
[LOGO] BIOCRYST
PHARMACEUTICALS, INC.
BIOCRYST PHARMACEUTICALS, INC.
2190 PARKWAY LAKE DRIVE
BIRMINGHAM, AL 35244
205-444-4600 205-444-4640 FAX
www.biocryst.com
Contacts:
BioCryst Pharmaceuticals, Inc. Euro RSCG Life NRP
Michael A. Darwin Sharon Weinstein (Investors)
Chief Financial Officer (212) 845-4271
(205) 444-4600 Wendy Lau (Media)
(212) 845-4272
FOR IMMEDIATE RELEASE
BIOCRYST PHARMACEUTICALS INITIATES
PHASE II CLINICAL TRIAL OF BCX-1777 IN T-CELL LEUKEMIA
Birmingham, Alabama - March 31, 2004 - BioCryst Pharmaceuticals, Inc. (Nasdaq
NM: BCRX) announced today that the first patient has been dosed in its Phase IIa
trial of BCX-1777, the Company's purine nucleoside phosphorylase (PNP) inhibitor
that is currently in clinical development for treatment of T-cell cancers. The
small-molecule drug, which causes biochemical changes that result in blocking of
the T-cell's DNA synthesis machinery, recently received orphan drug designation
from the U.S. Food and Drug Administration for treatment of T-cell non-Hodgkin's
lymphoma.
The Phase II clinical trial is a multicenter, global, open-label study to
determine the efficacy of long-term dosing with BCX-1777. The trial will be
divided into two parts, Phase IIa and IIb. The Phase IIa study will evaluate
response rate and duration of response in 20 patients with refractory T-cell
leukemia who have failed 2 previous treatments. The six-week dosing regimen will
consist of consecutive seven-day cycles. Patients will receive a once-daily
infusion of the drug at 40 mg/m2 for five days, followed by a two-day rest
period. If indicated, the dose may be increased to 90mg/m2 after two cycles. The
primary endpoint will be leukemic cell counts in both the peripheral blood and
the bone marrow. BioCryst anticipates results from Phase IIa to be available
during 2004. Assuming the clinical data from the first part of the trial is
sufficiently positive, BioCryst expects to initiate a larger Phase IIb study of
up to 100 patients. The company intends to seek Special Protocol Assessment from
the FDA for the Phase IIb trial.
"We are pleased to have made such substantial progress with BCX-1777 in such a
short time, and this is a very exciting milestone for us," said Dr. Charles
Bugg, Chairman and Chief Executive Officer of BioCryst. "The data we have seen
to date indicate that BCX-1777 is well tolerated by patients and has the
potential to dramatically lower leukemic cell counts and prevent T-cell
proliferation without cytotoxic effect on other cell functions. We are anxious
to move this product candidate forward as quickly as possible, in order to reach
cancer patients who have exhausted other treatment options for this rare but
deadly form of the disease."
About T-Cell Cancers
The human immune system employs specialized cells, including T-cells, to control
infection by recognizing and attacking disease-causing viruses, bacteria and
parasites. T-cells are an essential part of the body's immune system that serve
a dual purpose to both orchestrate and participate in the body's immune
response. For the most part, this system works flawlessly to protect the body.
However, when T-cells multiply uncontrollably, T-cell proliferative diseases,
including T-cell cancers, occur. The most common form of leukemia in children is
acute lymphoblastic leukemia (also known as ALL). According to the American
Cancer Society, 3,830 new cases (adult and children combined) will be diagnosed
in the United States in 2004.
About BioCryst
BioCryst Pharmaceuticals, Inc. designs, optimizes and develops novel drugs that
block key enzymes essential for cancer, cardiovascular and 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. In addition to the Phase IIa trial, enrollment in four Phase I
trials for BioCryst's lead product candidate, BCX-1777, is ongoing at nine U.S.
cancer centers for patients with T-cell malignancies, hematologic malignancies,
and other refractory cancers. BioCryst has several new enzyme targets in drug
discovery including tissue factor/factor VIIa and hepatitis C polymerase. For
more information about BioCryst, please visit the company's web site at
www.biocryst.com.
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 BCX-1777, that BCX-1777 or any of our other product candidates may not
receive required regulatory clearances from the FDA, that Phase IIa clinical
trials of BCX-1777 may not show the drug is effective over the 6-week period,
that we may not be able to obtain a Special Protocol Assessment or otherwise be
able to complete successfully the Phase IIb that is currently planned, that we
may not be able to continue future development of BCX-1777 or any of our other
current development programs including tissue factor/factor VIIa and hepatitis C
polymerase, that BCX-1777 or our other development programs may never result in
future product, license or royalty payments being received by BioCryst, 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 BioCryst's most recent Annual
Report on Form 10-K, which identify important factors that could cause the
actual results to differ materially from those contained in the projections or
forward-looking statements.
# # #