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): July 20, 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
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Item 5. Other Event..........................................................3
Item 7. Exhibit..............................................................3
Signature....................................................................4
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Item 5. OTHER EVENT
On July 20, 1999 the Company issued the press release attached hereto as
Exhibit 99.1.
Item 7. EXHIBIT
99.1 Press Release dated July 20, 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: July 20, 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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AT THE COMPANY AT THE FINANCIAL RELATIONS BOARD
Robert E Klem, Ph.D. For General Info: Susan Jayson (212) 661-8030
Vice President For Analyst Info: Brian Gill (212) 661-8030
(781) 860-5108 For Media Info: Deanne Eagle (212) 661-8030
FOR IMMEDIATE RELEASE:
July 20, 1999
GENTA RECIEVES NOTICE OF ALLOWABLE CLAIMS FOR U.S. PATENT FOR
USE OF BCL-2 ANTISENSE TO TREAT CANCER
Claims Protect Genta's Antisense Approach to Treating Many Forms of Cancer
Lexington, MA, July 20, 1999 - Genta Incorporated (Nasdaq: GNTA) today announced
that it has received a notice of allowance of several important claims for a
U.S. patent from the United States Patent and Trademarks Office. These allowed
claims will offer broad protection for the use of an antisense approach to
controlling the gene expression of the BCL-2 protein. The claims cover the use
of antisense targeted to the bcl-2 gene, which includes Genta's lead drug
candidate G3139, to sensitize cancer cells or to kill cancer cells with bcl-2
antisense either alone or in combination with chemotherapy agents.
The BCL-2 protein has been reported to be important in many cancers and is the
target of Genta's anticancer drug, G3139. Accordingly, with the allowance of
these claims, Genta's antisense approach has the potential for protection in the
treatment of a large number of different cancers.
Genta's G3139, either alone or in combination with a number of currently
available chemotherapeutic agents, has shown the ability to kill human cancer
cells in several animal models including lymphoma, prostate, melanoma and breast
cancers. Currently, Genta has seven ongoing Phase 1/2a and Phase 2 clinical
studies of its G3139 drug., Based on data obtained from these studies, Genta is
planning on expanding its Phase 2 program by the end of 1999.
"The issuance of these claims," said Dr. Robert E. Klem, Vice President and
Chief Technical Officer of Genta, "will provide patent protection for not only
our lead anticancer drug G3139 used alone or in combination with chemotherapy
agents, but also for any antisense targeting the bcl-2 gene. We believe these
claims will afford Genta broad protection for its approach to treating
metastatic cancers."
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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To receive Genta Incorporated's latest news release and other corporate
documents via fax, at no cost, dial 1-800-PRO-INFO; use the Company's symbol
GNTA. Or visit The Financial Relations Board's web site at www.frbinc.com.
The statements contained herein, including the background information
that follows, 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. 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. Examples of such risks and uncertainties 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, including the issuance of the
patent containing the allowed claims described herein; the impact of competitive
products and pricing and reimbursement policies; and the changing of market
conditions. The Company does not undertake to update any forward-looking
statements.
BACKGROUNDER
Apoptosis, Cancer, Bcl-2, G3139, and Antisense
The body's cells are normally programmed to detect damage in their
genetic makeup and to enter into a suicidal state when such alterations are
detected. This natural process, known as apoptosis or "programmed cell death,"
helps the body regulate its own well being by destroying damaged cells. In many
cancer cells, however, this process of natural cell death is inhibited by the
over expression of a protein called BCL-2, which is produced by a gene
identified as bcl-2. Consequently these cancer cells, even though damaged,
resist dying and continue multiplying. In many cases, cell types that over
produce the BCL-2 protein are also resistant to chemotherapeutic agents, many of
which act by stimulating apoptosis, and these cancers have been associated with
an unfavorable prognosis. For example, it has been reported that BCL-2 protein
is over produced in virtually all hormone-refractory, metastatic prostate
cancer; 80%-90% of estrogen-receptor-positive breast cancer; 70%-100% of
follicular lymphomas; and up to 90% of malignant melanomas. BCL-2 has also been
reported to be up-regulated in some lung, gastric, and colorectal cancers.
Using a single drug based on the genetic sequence of the bcl-2 gene,
Genta Incorporated is developing a novel therapeutic approach to treating
several cancers. Genta developed this synthetic, DNA-like molecule, identified
as G3139, designed to bind specifically to a small segment of the messenger RNA,
which forms the harmful BCL-2 protein. Once bound to the messenger RNA, the
messenger RNA is destroyed, preventing the production of the
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BCL-2 protein. (This type of interference with the process whereby genes produce
proteins through their messenger RNA has been called "antisense.") The goal of
this therapeutic approach is to restore the diseased cells' sensitivity to
apoptotic stimuli, including chemotherapeutic agents (an effect that has been
termed "chemosensitization").
In February 1998, a report of such chemosensitization appeared in
Nature Medicine, a peer-reviewed, scientific journal, G3139 was shown to enhance
the effect of a standard chemotherapeutic agent, DTIC or dacarbazine, in a mouse
model of human malignant melanoma. In two experiments with a total of 13
animals, 10 had no tumor after the combined treatment, and the other three
showed an average reduction in tumor weight of 90% compared to the DTIC-alone
treated, control animals. Other reports of preclinical studies in breast tumors,
prostate cancer, and lymphoma have been presented by investigators at the
American Association for Cancer Research meeting in April, 1999.
Genta is now in the clinical development phases of G3139. A phase 1
study at the Royal Marsden Hospital in London has been completed, and several
phase 1/2a studies are in progress in North America and Europe. A preliminary
report of the phase 1 study at the Royal Marsden was published in The Lancet in
April 1997, and an update was presented at the American Society of Clinical
Oncology (ASCO) in May, 1999. Although this was primarily a safety study, the
investigators reported very encouraging biological clinical activity of the
drug, including one complete response to G3139 alone. In addition, preliminary
reports from two other trials were presented at the ASCO meeting.
In addition to these studies, the National Cancer Institute of the
National Institutes of Health and Genta have entered into a Cooperative Research
and Development Agreement (CRADA) to further the development of G3139. Through
this CRADA, the NCI will sponsor trials using its network of investigators that
is planned to expand and accelerate the development of this G3139.
