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): June 24, 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 June 24, 1998 the Company issued the press release attached hereto
as Exhibit 99.1.
ITEM 7. EXHIBIT
99.1 Press Release dated June 24, 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: June 25, 1998 /s/ Kenneth G. Kasses, Ph.D.
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Kenneth G. Kasses, Ph.D.
President and Chief
Executive Officer
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FOR IMMEDIATE RELEASE Contact: Robert E. Klem, Ph.D.
Vice President
805-544-8524
GENTA SIGNS LETTER OF INTENT WITH NATIONAL CANCER INSTITUTE
FOR COLLABORATIVE RESEARCH & DEVELOPMENT AGREEMENT
COLLABORATION WILL STUDY G3139 IN VARIOUS CANCERS
SAN DIEGO, CA, June24, 1998 -- Genta Incorporated (Nasdaq: GNTA) and the
National Cancer Institute (NCI), one of the National Institutes of Health, today
announced that they have signed a letter of intent to enter into a Cooperative
Research and Development Agreement (CRADA) for the development of Genta's G3139
compound as an anticancer agent.
Under the CRADA, the NCI and Genta would collaborate in the conduct of clinical
trials of G3139, which has shown promising activity in specific malignancies in
preclinical models. The goal of the collaboration would be 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.
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.
"Genta is very excited about having the National Cancer Institute's support in
our efforts to develop G3139," said Kenneth Kasses, Ph.D., President and CEO of
Genta. Genta currently has phase I/IIa clinical trials underway at Memorial
Sloan-Kettering Cancer Center in New York and Royal Marsden Hospital in London.
"Genta will continue to support additional studies with investigators outside
the collaboration with the NCI, so this agreement would complement our own
program."
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.
The statements contained in this press release that are not historical are
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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; 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.
-Background to Follow-
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BACKGROUNDER
APOPTOSIS, CANCER, Bcl-2, AND G3139
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
produces the harmful Bcl-2 protein. Once bound to the messenger RNA, the
messenger RNA is destroyed, preventing the production of the 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 many 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.
Genta is now in the clinical development phases of G3139. A phase I study at the
Royal Marsden Hospital in London has been completed, and a phase I/IIa study is
in progress at the Memorial Sloan-Kettering Cancer Center in New York City. A
preliminary report of the study at the Royal Marsden was published in The Lancet
in April 1997. 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. Other clinical studies are also in
development and should be initiated beginning very shortly.
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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.
The statements contained herein 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; 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.
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