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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Date of Report (Date of earliest event reported) May 13, 1999
Commission File Number 0-23155
TRIMERIS, INC.
(Exact name of registrant)
Delaware 56-1808663
(State of organization) (I.R.S. Employer Identification Number)
4727 University Drive, Suite 100, Durham, North Carolina 27707
(Address of principal executive offices and zip code)
(919) 419-6050
(Registrant's telephone Number)
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ITEM 5. OTHER EVENTS
Trimeris, Inc. incorporates herein by reference the
information contained in the press release filed as Exhibit 99 to this Current
Report.
ITEM 7. EXHIBITS
EXHIBIT NO.
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99 Press Release by Trimeris, Inc., dated May 13, 1999
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SIGNATURE
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.
TRIMERIS, INC.
By: /s/ Matthew A. Megaro
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Matthew A. Megaro
President and Chief Financial Officer
Dated: May 17, 1999
EXHIBIT NO. 99
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Contacts:
Trimeris, Inc. Burns McClellan, Inc.
Matthew A. Megaro John Nugent (investors)
President/Chief Financial Officer Justin Jackson (media)
919-419-6050 212-213-0006
For Immediate Release
TRIMERIS' T-1249, SECOND HIV FUSION INHIBITOR,
RECEIVES FAST TRACK DESIGNATION FROM FDA
DURHAM, NC, MAY 13, 1999 -- Trimeris, Inc. (NASDAQ: TRMS) announced today that
T-1249 has received fast track designation from the United States Food and Drug
Administration for the treatment of HIV infected individuals. T-1249 is the
company's second drug candidate in a new class of anti-HIV compounds that block
the entry of the virus into cells. Fast track designation is granted to products
that may provide a significant improvement in the safety or effectiveness of the
treatment for a serious or life-threatening disease, and this designation is
intended to expedite the FDA's review of these drugs.
T-1249 is a rationally designed proprietary peptide which blocks fusion of HIV
with host cells. T-1249 has demonstrated potent HIV suppression in animal models
and is highly active against a wide range of HIV strains in culture.
"We are very pleased that T-1249 has received fast track designation,
particularly at this early stage of its development," stated Dr. Dani Bolognesi,
Chief Executive Officer of Trimeris. "We are excited about the upcoming T-1249
Phase I trial planned for this quarter and look forward to expanding the fusion
inhibitor class."
Trimeris is a development stage biopharmaceutical company engaged in the
discovery and development of novel therapeutic agents that treat viral infection
by inhibiting viral fusion with host cells. The company's lead product
candidate, T-20, which inhibits fusion of the human immunodeficiency virus (HIV)
with host cells, is currently in Phase II clinical trials. T-20 has also
received fast track designation from the FDA.
NOTE: Except for any historical information presented herein, matters presented
in this release are forward-looking statements that involve risks and
uncertainties. The results of the company's previous clinical trials are not
necessarily indicative of future clinical trials, and future results could
differ materially from the results presented herein. Factors that could cause or
contribute to such differences include, but are not limited to, those discussed
in the "Risk Factors" section included in the company's Registration Statement
on Form S-3 filed with the Securities and Exchange Commission on April 30, 1999.
