Andy, This morning BRCX announced two disappointing results in its Phase III trials for topical treatment of psorisis and CTCL. This news is bad for Biotechs in general, but may actually be good news for LGND. If approved, the compound would have competed with topical Panretin which has just completed Phase II for psoriasis and is ready to begin Phase III. The BRCX treatment would also compete with topical Targretin for CTCL. Topical Targretin is in pivotal Phase III trials for CTCL:
Friday September 26 8:01 AM EDT
Company Press Release
BioCryst Pharmaceuticals, Inc. Announces Preliminary
Phase III Trial Data for a Topical Cream Formulation of
Lead Drug Candidate, BCX-34
BIRMINGHAM, Ala.--(BW HealthWire)--Sept. 26, 1997--BioCryst Pharmaceuticals, Inc.
(Nasdaq:BCRX) announced today preliminary Phase III trial data for two trials with a topical cream
formulation of the Company's lead drug candidate, BCX-34. Initial findings from a Phase III clinical
study for the treatment of psoriasis and a Phase III trial to treat cutaneous T-cell lymphoma (CTCL)
demonstrated no statistical differences in the achievement of study endpoints between
BCX-34-treated and placebo groups.
The primary endpoint for the Company's Phase III CTCL trial was a 50 percent or greater decrease
in body surface area covered with patch and plaque cancerous lesions during the six-month course
of treatment. The CTCL trial included 90 patients who had primarily early stage patch disease. The
response rate for the patients treated with topical BCX-34 was 28 percent, compared with 24
percent for the placebo group (p = 0.68). ``In our preliminary analysis of the Phase III CTCL data,
we were surprised to see such a high placebo response rate, which was totally unexpected and not
previously documented in the scientific literature,'' commented George A. Omura, M.D., Vice
President of Clinical Development and Medical Director of BioCryst Pharmaceuticals.
The Phase III psoriasis trial endpoints consisted of quantitative scores for target skin lesions, plus an
overall physician evaluation of patient improvement during the four-month treatment period. In the
psoriasis study, which included 351 patients, the BCX-34-treated patients showed a 14 percent
greater improvement in mean lesion scores than patients receiving placebo, but this difference was
not statistically significant (p = 0.29). Physician evaluation of patient improvement (defined as at least
75 percent clearance of disease) indicated an overall improvement in 11 percent of the patients in
the BCX-34-treated group, and in 15 percent of the patients in the placebo group (p = 0.30).
``We are continuing to analyze the data from the Phase III trials, but we do not expect to see any
overall change in these general results,'' commented Charles E. Bugg, Ph.D., Chairman and CEO of
BioCryst Pharmaceuticals. ``Currently, we do not plan to pursue further development of this topical
cream formulation of BCX-34.''
BioCryst is now conducting a Phase II clinical trial with a topical ointment formulation of BCX-34 in
Denmark, as well as Phase I/II trials of an oral formulation of BCX-34 for treatment of cutaneous
T-cell lymphoma and psoriasis. Further, BioCryst is conducting a Phase I feasibility study of an oral
formulation of BCX-34 for patients infected with HIV.
Founded in 1986, BioCryst Pharmaceuticals, Inc. designs and develops novel small-molecule
pharmaceuticals using structure-based drug design, an approach to drug discovery that integrates
advanced biology, biophysics and medicinal chemistry. The Company is developing drug treatments
for immunological and viral diseases. In addition to its T-cell inhibition program, the Company is
pursuing preclinical programs to develop drugs to inhibit the influenza neuraminidase enzyme
associated with flu infection and to inhibit activation of the complement pathway implicated in a
number of immunological and cardiovascular diseases.
This press release contains projections or other forward-looking statements regarding future events
or the future financial performance of the Company. These statements are only predictions and the
actual events or results may differ materially. Please refer to the documents BioCryst files from time
to time with the Securities and Exchange Commission, specifically BioCryst's most recent Form
10-K and Form 10-Q. These documents contain and 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. Burns McClellan, Inc.
A.K. Schleusner Jonathan M. Nugent (Investors)
205-444-4600 Miriam Weber (Media)
212-213-0006
More news for referenced ticker symbols: BCRX, and related industries: biotechnology,
medical. |
