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): July 14, 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 July 14, 1998 the Company issued the press release attached hereto
as Exhibit 99.1.
ITEM 7. EXHIBIT
99.1 Press Release dated July 14, 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: July 14, 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 TO COMMENCE SECOND PHASE I/IIa PROSTATE CANCER TRIAL
OF bcl-2 ANTISENSE COMPOUND
SAN DIEGO, CA, JULY 14, 1998 -- Genta Incorporated (Nasdaq: GNTA) today
announced that it will initiate a new Phase I/IIa study of its lead development
compound G3139 at the Sidney Kimmel Cancer Center in San Diego, CA. This study,
under the direction of Dr. John Gutheil, Director, Clinical Oncology Research,
will examine the safety and efficacy of G3139 in the treatment of
hormone-resistant, metastatic prostate cancer when administered over a
significantly longer duration than previously studied and in combination with an
androgen-receptor blocking agent.
Prostate cancer is the most common malignancy in men in the United States and
the second leading cause of death behind lung cancer. While hormonal therapy has
been very effective in the treatment of this disease, the disease-free interval
has a median time of 18 to 24 months. In addition, the overall survival for
patients found to be androgen-insensitive is only 6 to 9 months.
"The research team at the Sidney Kimmel Cancer Center is very excited about the
opportunity to work on the G3139 trials," noted Dr. Gutheil. "We believe that
our selection to participate in this research is a reflection of our growing
reputation as a leader in cancer studies."
"This new trial is a part of Genta's on going program to expand the clinical
data base for G3139," said Kenneth G. Kasses, Ph.D., President and CEO. "We are
very pleased to be able to include the Sidney Kimmel Cancer Center among our
investigational sites. It has been very rewarding to us to have prominent cancer
centers interested in working with us to further the development of this
technology."
BACKGROUND INFORMATION ON 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
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Genta Incorporated July 14, 1998
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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. The first combination drug trial using
G3139 and DTIC in malignant melanoma is starting at the University of Vienna
conducted by the same investigators who published the work cited in Nature
Medicine, above. Other clinical studies are also in development and should be
initiated in the coming months.
Genta Incorporated (Nasdaq: GNTA) is a biopharmaceutical company focused on
building a product and technology portfolio based 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 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-
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Genta Incorporated July 14, 1998
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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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