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): February 2, 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)
<PAGE>
GENTA INCORPORATED
FORM 8-K
CURRENT REPORT
TABLE OF CONTENTS
Item 5. Other Event
Item 7. Exhibit
Signature
- 2 -
<PAGE>
ITEM 5. OTHER EVENT
On February 2, 1998 the Company issued the press release attached
hereto as Exhibit 99.1.
ITEM 7. EXHIBIT
99.1 Press Release dated February 2, 1998.
- 3 -
<PAGE>
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: February 2, 1998 /s/ Kenneth G. Kasses, Ph.D.
----------------------------
Kenneth G. Kasses, Ph.D.
President and Chief
Executive Officer
- 4 -
Exhibit 99.1
Contacts:
Kenneth G. Kasses Mary Ann Dunnell
Genta Incorporated Robinson Lerer & Montgomery
781-402-3450 212-484-7797
FOR IMMEDIATE RELEASE
- ---------------------
ARTICLE IN LEADING SCIENTIFIC JOURNAL SPOTLIGHTS USE OF GENTA'S BCL-2
ANTISENSE COMPOUND IN INCREASING RESPONSE TO A CHEMOTHERAPEUTIC DRUG
PRE-CLINICAL STUDIES SHOW SIGNIFICANT TUMOR REDUCTION
IN MOUSE TRANSPLANT MODEL OF HUMAN MELANOMA
SAN DIEGO, CA, FEBRUARY 2, 1998 -- Genta Incorporated (Nasdaq: GNTA) today
announced that the February issue of NATURE MEDICINE, a leading scientific
peer-reviewed journal, contains an article demonstrating the effectiveness of
Genta's G3139 antisense compound as a chemosensitizer in an animal model of
human melanoma. In experiments conducted at the University of Vienna, Austria,
researchers showed that, by pre-treating the animals with G3139, they could
significantly increase the effectiveness of a chemotherapeutic drug.
The study examined the effect of G3139 on dacarbazine (DTIC) sensitivity in a
human melanoma transplant in immuno-compromised mice compared to three control
groups: a saline control, a reverse sequence antisense oligonucleotide and a
mismatched pair oligonucleotide. When DTIC, the most widely used
chemotherapeutic agent in melanoma, was administered to the animals, the mean
tumor weights in all three control groups were not significantly different but
the G3139 group had a mean tumor weight close to zero and the tumor was
completely ablated in ten out of thirteen animals. In a separate experiment, the
authors also demonstrated that the antisense compound, G3139, alone had a
significantly greater effect in reducing tumor growth than did the three control
treatments.
The reported research was directed by Dr. Burkhard Jansen, Department of
Clinical Pharmacology and Dermatology, University of Vienna, Austria, the lead
author of the NATURE MEDICINE article. The authors noted that their data suggest
"that Bcl-2 contributes to the lack of chemosensitivity of human melanoma. This
lack of chemosensitivity may be overcome by bcl-2 antisense therapy."
-more-
<PAGE>
-2-
"We have always believed that G3139 had potential as a chemosensitizer,
hypothesizing that tumors become resistant to chemotherapy due, at least in
part, to the expression of the bcl-2 gene, which protects the cells from
apoptosis (programmed cell death)," stated Kenneth G. Kasses, President and
Chief Executive Officer of Genta. "We have always theorized that G3139, by
downregulating the Bcl-2, should resensitize the cells to chemotherapy and cell
death. The results presented in NATURE MEDICINE are the strongest evidence we've
seen to date to support this hypothesis.
"Of course, we recognize that the studies to date constitute early-stage
research, and that substantial additional pre-clinical and clinical research
will be required to prove the effect of G3139 as a chemosensitizer in humans.
However, we are extremely encouraged by these results and intend to pursue human
studies as soon as practicable to support these findings. We believe that a
clinical study replicating these mice experiments could be commenced by the
second half of this year."
ABOUT BCL-2 ANTISENSE
Chemotherapeutic drugs are believed to work by causing programmed cell death, or
apoptosis, in tumor cells. However, the authors state that up to 90 percent of
human melanomas are known to express a gene called bcl-2, which produces a
protein that blocks the process of apoptosis, thereby keeping the cancer cells
from dying and allowing them to reproduce freely. bcl-2 antisense removes the
barrier to apoptosis, which may increase responsiveness to the chemotherapeutic
drug. The antisense molecule works by binding to messenger RNA in tumor cells
and preventing it from producing Bcl-2.
Genta believes that Bcl-2 expression also contributes to chemotherapeutic
resistance in other cancers. For example, Genta estimates that Bcl-2 is
upregulated in approximately 70 percent of breast cancers; 90 percent of
androgen-insensitive prostate cancers; and 65-70 percent of non-Hodgkin's
lymphomas.
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
-more-
<PAGE>
-3-
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.
# # # #
