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): May 3, 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)
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GENTA INCORPORATED
FORM 8-K
CURRENT REPORT
TABLE OF CONTENTS
Page
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Item 5. Other Event...........................................................3
Item 7. Exhibit...............................................................3
Signature.....................................................................4
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Item 5. OTHER EVENT
On May 3, 1999 the Company issued the press release attached hereto as
Exhibit 99.1.
Item 7. EXHIBIT
99.1 Press Release dated May 3, 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: May 3, 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
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Howard Fingert M.D. For General Info: Paul G. Henning (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:
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May 3, 1999
GENTA TO COMMENCE PHASE I/IIa TRIAL OF BCL-2 ANTISENSE COMPOUND
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ADMINISTERED WITH TAXOTERE(R) (DOCETAXEL)
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AT LOMBARDI CANCER CENTER
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Study will be first to focus on combination treatment with docetaxel,
a chemotherapy widely used for breast and other cancers.
LEXINGTON, MA, May 3, 1999 - Genta Incorporated (Nasdaq: GNTA) today announced
it has initiated a new Phase I/IIa study of its lead development compound G3139
at the Lombardi Cancer Center at Georgetown University Medical Center in
Washington, D.C.
The study will investigate G3139 administered with Taxotere(R) (docetaxel), a
chemotherapeutic agent used widely to treat breast cancer and other
malignancies. The principal investigator is Dr. Daniel Hayes, Clinical Director,
Breast Cancer Program at the Lombardi Cancer Center. Co-investigators are Drs.
Marc Lippman, John Marshall and Helen Chen.
G3139 is designed to reduce the Bcl-2 protein level in cancer through an
"antisense" mechanism that specifically targets the bcl-2 gene product. In
several human cancers, the protein produced by the bcl-2 gene is believed to be
a major factor in resistance to treatment with many anticancer drugs, including
docetaxel.
The Lombardi Cancer Center and Genta have had a long-standing collaboration and
recently completed a preclinical program leading to this clinical trial. At the
recent meeting of the American Association for Cancer Research, Dr. Dajun Yang
reported on the results of his laboratory work conducted in collaboration with
Dr. Marc Lippman, the Center's Director.
As part of their investigation of the molecular events behind the growth and
treatment response of human breast cancers, Dr. Yang's team demonstrated
dramatic reduction of Bcl-2 protein in human breast cancers when G3139 was
administered. The team then applied these findings to the development of a new
strategy for therapy. By administering G3139 in combination with docetaxel in a
mouse model, Dr. Yang reported that the therapy was effective in causing both
apoptosis (programmed cell death) and major regressions of human breast cancers.
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The positive effect of the combination therapy was evident even in the treatment
of larger tumors and presents a model for the treatment of more advanced
clinical disease. In fact, some studies demonstrated durable regression of human
breast tumors that persisted for months with no sign of recurrence after the
combination treatment stopped.
"The Lombardi Cancer Center's clinical research team has both the dedication and
expertise to conduct clinical trials in support of Genta's G3139 development
program," said Kenneth G. Kasses, Ph.D., Genta's President and CEO. "Moreover,
based on the researchers' rational application of their discoveries about the
molecular biology of breast cancer to the clinical trials, we are hopeful that a
new treatment approach will develop."
According to Dr. Kasses, Taxotere(R) and related drugs (taxanes) are now some of
the most widely used for treatment of cancer around the world. Accordingly, data
from the Lombardi Cancer Center's study, using the G3139 combination, could have
broad impact on future clinical research and development of G3139.
Genta Incorporated is a biopharmaceutical company whose strategy consists of
building a product and technology portfolio focusing on its Anticode(TM)
(antisense) products intended to treat cancer at its genetic source.
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
expectations 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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