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
Date of Report (Date of earliest event reported): April 21, 1999
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GENTA INCORPORATED
(Exact name of registrant as specified in its charter)
Commission file number 0-19635
Delaware 33-0326866
(State or other jurisdiction of (I.R.S. Employer Identification
incorporation or organization) Number)
99 Hayden Avenue, Suite 200, Lexington, Massachusetts 02421
(Address of principal executive offices)
(Zip Code)
(781) 860-5150
(Registrant's telephone number, including area code)
3550 General Atomics Court, San Diego, CA 92121
(Former address)
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GENTA INCORPORATED
FORM 8-K
CURRENT REPORT
TABLE OF CONTENTS
Page
Item 5. Other Event.......................................................3
Item 7. Exhibit...........................................................3
Signature.................................................................4
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Item 5. OTHER EVENT
On April 21, 1999 the Company issued the press release attached hereto
as Exhibit 99.1.
Item 7. EXHIBIT
99.1 Press Release dated April 21, 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.
Date: April 21, 1999
GENTA INCORPORATED
/s/ Kenneth G. Kasses, Ph.D.
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Kenneth G. Kasses, Ph.D.
President, Principal Executive Officer and
Director
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Exhibit 99.1
Press Release
AT THE COMPANY AT THE FINANCIAL RELATIONS BOARD
Howard Fingert, M.D. For General Info: Susan Jayson (212) 661-8030
Vice President For Analyst Info: Brian Gill (212) 661-8030
(781) 860-5150 For Media Info: Deanne Eagle (212) 661-8030
FOR IMMEDIATE RELEASE:
April 21, 1999
GENTA ENTERS COOPERATIVE RESEARCH AND DEVELOPMENT
AGREEMENT WITH NATIONAL CANCER INSTITUTE
Collaboration Will Study G3139 in Various Cancers
LEXINGTON, MA, April 21, 1999 -- Genta Incorporated (Nasdaq: GNTA) announced
that they have entered into a Cooperative Research and Development Agreement
(CRADA) with the National Cancer Institute for the development of Genta's G3139
compound as an anticancer agent.
Under the CRADA, the NCI and Genta will collaborate in the conduct of clinical
trials of G3139, which has shown promising activity in preclinical models and
early clinical trials. The goal of the Genta and NCI collaboration is to provide
the best treatment options to patients with specific cancer indications and
ultimately to obtain approval of G3139 as a commercial anticancer agent if
warranted by the clinical results. The collaboration will focus on colorectal
cancer, small cell lung cancer, and relapsed or resistant leukemia.
As an antisense compound, G3139 is designed to act toward a specific gene and
prevent it from triggering the production of disease-related protein. G3139's
target, the bcl-2 gene, interferes in the normal mortality of cells (apoptosis)
and has been implicated in prostate cancer, non-Hodgkin's lymphoma, melanoma,
breast, colon, lung, and other cancers. At the recently concluded Annual Meeting
of the American Association for Cancer Research, scientists from independent
academic centers presented studies that demonstrated the enhanced effects of
G3139 and chemotherapeutic agents in a human breast cancer xenograft model; a
human lymphoma xenograft model; and using the mouse analogue of G3139 in a model
of prostate cancer.
"Genta is very excited to be working with the National Cancer Institute in our
efforts to develop G3139," said Kenneth G. Kasses, Ph.D., President and CEO of
Genta. Genta currently has several phase I and II clinical trials underway in
the United States, Canada, and Europe. "Genta will continue to support studies
of other tumor types with investigators outside the collaboration with the NCI,
so this agreement will complement our own program to define the biological and
clinical impact of G3139 in cancer therapy."
Genta Incorporated (Nasdaq: GNTA) is a biopharmaceutical company whose strategy
consists of building a product and technology portfolio concentrating on its
Anticode(TM) (antisense) products intended to treat cancer at its genetic
source.
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The statements contained in this press release that are not historical are
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended, including statements regarding the expectations, beliefs, intentions
or strategies regarding the future. Without limiting the foregoing, the words
"anticipates," "believes," "expects," "intends," "may" and "plans" and similar
expressions are intended to identify forward- looking statements. The Company
intends that all forward-looking statements be subject to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect the Company's views as of the date they are
made with respect to future events, but are subject to many risks and
uncertainties, which could cause the actual results of the Company to differ
materially from any future results expressed or implied by such forward-looking
statements. For example, the results obtained in pre-clinical studies may not be
indicative of results that will be obtained in clinical trials; Genta has not
successfully completed human clinical trials of a product based on antisense
technology; and delays in the completion of clinical trials as a result of
delays in patient enrollment or other factors may occur. Examples of such risks
and uncertainties also include, but are not limited to: the obtaining of
sufficient financing to maintain the Company's planned operations; the timely
development, receipt of necessary regulatory approvals and acceptance of new
products; the successful application of the Company's technology to produce new
products; the obtaining of proprietary protection for any such technology and
products; the impact of competitive products and pricing and reimbursement
policies; and the changing of market conditions. The Company does not undertake
to update forward-looking statements.
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