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): December 3, 1997
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 December 3, 1997, the Company issued the press release attached
hereto as Exhibit 99.1.
ITEM 7. EXHIBIT
99.1 Press Release dated December 3, 1997.
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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: December 3, 1997 /s/ Kenneth G. Kasses, Ph.D.
----------------------------
Kenneth G. Kasses, Ph.D.
President and Chief
Executive Officer
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Exhibit 99.1
FOR IMMEDIATE RELEASE Contact: Kenneth G. Kasses, Ph.D.
#97C019 President and CEO
617-402-3450 or
619-455-2700
GENTA ANNOUNCES INITIATION OF PHASE I/IIa PROSTATE CANCER TRIAL AT
MEMORIAL SLOAN-KETTERING CANCER CENTER
G3139 COMPOUND BEGINS FIRST U.S. TRIAL
SAN DIEGO, CA, December 3, 1997 -- Genta Incorporated (Nasdaq: GNTA)
announced today that it has initiated a U.S. Phase I/IIa clinical trial at
Memorial Sloan-Kettering Cancer Center (MSKCC) to evaluate G3139, a lead
compound of Genta's Anticode(TM) technology, against prostate cancer. Prostate
cancer is the most common form of cancer among men--the American Cancer Society
estimates that more than 330,000 new cases and 41,000 deaths will occur in the
U.S. in 1997.
The first part of the Phase I/IIa study at MSKCC is designed to define
the maximum tolerated dose (MTD) or optimal biological dose with continuous
intravenous infusion; the second part is to determine the efficacy of the drug
in advanced, androgen independent prostate cancer. Patient recruitment is under
way at MSKCC in New York City and enrollment is expected to proceed in the near
future. A European Phase I/IIa trial utilizing G3139 against non-Hodgkin's
lymphoma is nearing completion.
GENTA'S ANTICODE(TM) COMPOUNDS: GENETIC CONTROL OF DISEASE
Cells in the human body produce, or "express," tens of thousands of
proteins which are essential for life. Many human diseases arise when cells
over-express certain normal proteins as a result of inherited or acquired
genetic defects. Anticode (antisense) compounds are short, synthetic strands of
DNA that halt this disease-causing process by binding with a specific messenger
ribonucleic acid (mRNA), preventing the over-expression of its protein.
The target of G3139--the BCL2 gene--has been implicated in prostate
cancer, non-Hodgkin's lymphoma, melanoma, breast and other cancers. BCL2 is a
proto-oncogene (a gene associated with malignancy) that acts as a major
inhibitor of apoptosis (programmed cell death) of cancerous cells. The protein
produced by this gene has two known critical functions in the progression of
cancer--it makes cancer cells immortal, creating a survival advantage for
malignant over normal cells and confers resistance to radiation and
chemotherapy, rendering these treatments ineffective in the late stages of many
types of cancers. G3139 is designed to inactivate the RNA that produces the BCL2
protein product, thereby preventing cellular production of the protein.
(more)
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Genta Incorporated December 3, 1997
Page 2 #97C019
Howard I. Scher, M.D., the trial's principal investigator and Chief of
the Genitourinary Oncology Service at the Memorial Sloan-Kettering Cancer
Center, commented, "We are very pleased to be collaborating with Genta on this
exciting antisense technology. It is our hope that this trial will lead to
further development of the technology and result in improved clinical outcomes
for our patients."
Kenneth G. Kasses, Ph.D., President and CEO of Genta, stated, "The
initiation of a U.S. trial for G3139 at Memorial Sloan-Kettering is a major
milestone for Genta. The MSKCC study is the first in a series of trials that we
plan to begin over the next year at prestigious institutions in North America to
study the safety and efficacy of G3139 in different cancers."
EUROPEAN PHASE I/IIa NON-HODGKIN'S LYMPHOMA TRIAL IN FINAL STAGE
A Phase I/IIa study of G3139 in non-Hodgkin's lymphoma at the Royal
Marsden Hospital in London is currently in its final stage to confirm MTD by
continuous subcutaneous infusion. While this study is designed primarily as a
safety study, biological activity of G3139 has been seen in seven patients of
the seventeen enrolled, including one complete response. Treatment of three
patients was discontinued as MTD was established. One patient experienced
hypotension and thrombocytopenia which resolved by discontinuing treatment, and
no adverse effects were noted when the patient was retreated at a lower dose.
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-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. The Company does not undertake to update any forward-looking
statements.
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.
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