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): April 19, 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
Item 5. Other Event...........................................................3
Item 7. Exhibit...............................................................3
Signature.....................................................................4
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Item 5. OTHER EVENT
On April 19, 1999 the Company issued the press release attached hereto
as Exhibit 99.1.
Item 7. EXHIBIT
99.1 Press Release dated April 19, 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: April 21, 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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Exhibit 99.1
Press Release
AT THE COMPANY AT THE FINANCIAL RELATIONS BOARD
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Howard Fingert, M.D. For General Info: Susan Jayson (212) 661-8030
Vice President For Analyst Info: Brian Gill (212) 661-8030
(781) 860-5150 For Media Info: Deanne Eagle (212) 661-8030
FOR IMMEDIATE RELEASE:
April 19, 1999
INVESTIGATORS REPORT GENTA'S ANTISENSE DRUG COMBINED WITH
STANDARD CHEMOTHERAPY CURES HUMAN LYMPHOMAS
AND BREAST CANCERS IN MOUSE MODELS
Results with G3139 Support Ongoing Clinical Program
LEXINGTON, MA, April 19, 1999 -- Genta Incorporated (Nasdaq: GNTA) announced
that scientists reported the results of preclinical studies with Genta's lead
product in development, G3139, at the recently concluded 90th annual meeting of
the American Association for Cancer Research (AACR) held in Philadelphia, PA.
G3139 was designed to reduce the Bcl-2 protein level in cancer through an
"antisense" mechanism that specifically targets the bcl-2 gene product. In
several human cancers, the protein produced by the bcl-2 gene is believed to be
a major factor in resistance to treatment with many anticancer drugs.
Researchers have proposed that G3139 could improve the treatment response of
human cancers when combined with anticancer drugs - especially when used in
cancers that are resistant to the anticancer drugs, a common clinical problem.
Dr. Dajun Yang and colleagues working with Dr. Marc Lippman from the Lombardi
Cancer Center, Georgetown University Medical Center, presented results of
studies with human breast tumors, testing G3139 in combination with standard
anticancer agents. Cell cultures of human breast cancers demonstrated that G3139
reduced the Bcl-2 protein levels and enhanced apoptosis, or programmed cell
death, when G3139 was combined with docetaxel (Taxotere(R)) and paclitaxel
(Taxol(R)), drugs that are widely used for clinical treatment of metastatic
breast cancer. Then using a mouse model with an aggressive form of human breast
cancer that consistently leads to death of the animals, treatments with G3139
plus docetaxel led to complete regression of the human breast tumors that lasted
beyond six months.
"We consider these mice to be cured of the breast cancer. This treatment
response could not be achieved using either drug alone," reported Dr. Yang.
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The treatment program used relatively low doses of the anticancer agent and the
mice demonstrated no treatment-related side effects. The investigators repeated
their treatments using mice with larger human breast tumors, modeling the
situation of patients who may have advanced, metastatic breast cancer. Again,
the results showed major, durable regression of the human breast tumors with no
major toxicities. Studies also provided evidence that G3139 reduces Bcl-2
protein levels in vivo within the human breast tumors.
Investigators from the BC Cancer Agency in British Columbia, Canada, reported
similar results with G3139 when combined with other anticancer drugs. Dr. Kim
Chi and colleagues reported major treatment response of human breast tumors
grown in mice after combined treatment with G3139 and doxorubicin, another agent
widely used for treatment of patients with breast cancer.
Using a model with human lymphoma in mice that consistently leads to death of
the mice in about 35 days, Drs. Frances M. P. Wong, Marcel Bally, and Richard
Klasa from the BC Cancer Agency reported that G3139 combined with
cyclophosphamide led to 100% survival and cures of mice that lived for more than
three months after treatment. In this model, the human lymphoma grows in
multiple organs including bone marrow, spleen, lymph nodes, and thereby imitates
the widespread distribution of clinical lymphomas and other advanced human
malignancies. The investigators used a low treatment dose of cyclophosphamide
that was well tolerated but could not produce major treatment response or cures
when used without the G3139 therapy. Cyclophosphamide is used widely for
treatment of human lymphoma, breast cancer, and other malignancies. The
investigators noted that the long-term cures of disseminated malignancy,
observed in the mice after G3139 plus low-dose chemotherapy, compares favorably
to outcomes from other treatment strategies, such as high- dose chemotherapy and
bone marrow transplantation, a strategy that is widely used for treatment of
human cancers but often limited by toxicities to normal tissues and high
requirements for health care resources.
Another study presented at AACR by Drs. Anthony Tolcher, Martin Gleave, and
colleagues at the Vancouver General Hospital and University of British Columbia,
demonstrated an additive effect of a G3139 analogue, specific to the mouse, when
combined with mitoxantrone in a mouse model of metastatic, hormone-independent
prostate cancer.
"More than just delays in tumor growth or short-term shrinkage, the actual cures
of human cancers, demonstrated from the animal models, after combined treatment
with G3139 and chemotherapy are certainly remarkable, since the animals were not
curable by standard chemotherapies given alone - a situation often similar to
the human disease" said Kenneth G. Kasses, Ph.D., CEO of Genta.
"The results, presented at AACR by independent academic investigators,
demonstrate striking consistency among different laboratories and across
different tumor types, and they provide the basis for rational design and
expansion of our clinical development program for G3139,
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combined with chemotherapies that are already widely used in cancer treatment.
Genta is collaborating with major medical centers in the U.S., Canada, and
Europe in conducting six on-going clinical trials that we hope will lead rapidly
to an understanding of the safety and utility of G3139 when combined with
anticancer drugs for treatment of common malignancies. In addition, these data
will support the expansion of our clinical program," said Dr. Kasses.
Genta Incorporated is a biopharmaceutical company whose strategy consists of
building a product and technology portfolio focusing 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 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
expectations 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. For example, the results obtained in pre-clinical studies may not be
indicative of results that will be obtained in clinical trials; Genta has not
successfully completed human clinical trials of a product based on antisense
technology; and delays in the completion of clinical trials as a result of
delays in patient enrollment or other factors may occur. Examples of such risks
and uncertainties also include, but are not limited to: the possibility that the
proposed Promega transaction will not be consummated; 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 forward-looking statements.
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