SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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 1, 1998
GENTA INCORPORATED
(Exact name of registrant as specified in its charter)
Commission file number 0-19635
Delaware 33-0326866
(State or other jurisdiction of (IRS Employer Identification Number)
incorporation or organization)
3550 General Atomics Court, San Diego, CA 92121
(Address of principal executive offices)
(Zip Code)
(619) 455-2700
(Registrant's telephone number, including area code)
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GENTA INCORPORATED
FORM 8-K
CURRENT REPORT
TABLE OF CONTENTS
Item 5. Other Event
Item 7. Exhibit
Signature
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ITEM 5. OTHER EVENT
On April 1, 1998 the Company issued the press release attached hereto
as Exhibit 99.1.
ITEM 7. EXHIBIT
99.1 Press Release dated April 1, 1998.
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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.
GENTA INCORPORATED
Date: April 2, 1998 /s/ Kenneth G. Kasses, Ph.D.
----------------------------
Kenneth G. Kasses, Ph.D.
President and Chief
Executive Officer
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Exhibit 99.1
Contact:
Mary Ann Dunnell
Robinson Lerer & Montgomery
212-484-7797
FOR IMMEDIATE RELEASE
GENTA ANNOUNCES ISSUE OF PATENT FOR LEAD ANTISENSE COMPOUND
THAT TARGETS THE BCL-2 GENE, IMPLICATED IN PROSTATE AND OTHER CANCERS
SAN DIEGO, CA, APRIL 1, 1998 -- Genta Incorporated (Nasdaq: GNTA) today
announced that it has received notification from the U.S. Patent and Trademark
Office that a patent has been issued for Genta's lead antisense compound, G3139,
which is under development as a potential anticancer therapeutic. The patent
provides protection for the composition of G3139 and its analogues.
"The protection this patent provides will aid in our continued development of
G3139 as a highly promising therapeutic for a variety of cancers," stated
Kenneth G. Kasses, President and Chief Executive Officer of Genta.
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 and other cancers.
Recent findings on G3139 were reported in the February 1998 issue of Nature
Medicine, a leading scientific peer-reviewed journal, concerning the
effectiveness of the compound as a "chemosensitizer" that causes tumors to lose
an acquired immunity to chemotherapy. In work conducted at the University of
Vienna that modeled human melanoma, researchers showed that pre-treating
laboratory mice with G3139 significantly increased the effectiveness of
dacarbazine (DTIC), the most widely used chemotherapeutic agent in melanoma. The
article reported that in 10 out of 13 animals so treated, cancerous tumors were
completely eliminated. The article also noted that, in a separate experiment,
G3139 used alone had a significantly greater effect in reducing tumor growth
than did the three control treatments.
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In December 1997, Genta announced the start of a Phase I/IIa clinical trial of
G3139 at New York City's Memorial Sloan-Kettering Cancer Center to evaluate the
compound against prostate cancer. In addition, a Phase I/IIa study of G3139 is
now nearing completion at the Royal Marsden Hospital in London to study the
compound's effect on non-Hodgkin's lymphoma.
Genta plans to initiate other pre-clinical and clinical studies this year to
evaluate the safety and efficacy of G3139 in other cancers.
Genta Incorporated (Nasdaq: GNTA) is a biopharmaceutical company whose strategy
consists of building a product and technology portfolio that represents varying
degrees of development risk and market potential, including Anticode(TM)
(antisense) products intended to treat cancer at its genetic source, oral
controlled-release drugs and other genomics opportunities.
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 and 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, including the following: the results obtained in pre-clinical
studies may not be indicative of results that will be obtained in clinical
trials; all of Genta's potential products are at an early stage of development;
neither Genta nor, to its knowledge, any other company, has successfully
completed human clinical trials of a product based on antisense technology;
there can be no assurance that Genta will receive regulatory approvals to
commence or continue clinical trials of product candidates or to market any
products or that delays in completion of clinical trials as a result of delays
in patient enrollment or other factors will not occur; and there can be no
assurance that Genta will be able to obtain adequate funding to achieve its
objectives. The Company does not undertake to update any forward-looking
statements.
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