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): May 18, 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)
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GENTA INCORPORATED
FORM 8-K
CURRENT REPORT
TABLE OF CONTENTS
Page
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Item 5. Other Event............................................................3
Item 7. Exhibit................................................................3
Signature......................................................................4
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Item 5. OTHER EVENT
On May 18, 1999 the Company issued the press release attached hereto as
Exhibit 99.1.
Item 7. EXHIBIT
99.1 Press Release dated May 18, 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: May 18, 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
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May 18, 1999
INVESTIGATORS REPORT ACTIVITY IN CLINICAL STUDIES
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OF GENTA'S ANTISENSE PRODUCT IN DRUG-RESISTANT CANCERS
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Results with G3139 in Patients with Prostate and Kidney Cancer,
Melanoma and Lymphoma Support Expanded Clinical Programs
LEXINGTON, MA, May 18, 1999 -- Genta Incorporated (Nasdaq: GNTA) announced the
results of clinical studies with Genta's lead cancer drug in development, G3139,
at the recently concluded 35th annual meeting of the American Society of
Clinical Oncology (ASCO) held May 15-18, 1999 in Atlanta, Georgia. Investigators
from the Royal Marsden Hospital in the U.K., the Memorial Sloan-Kettering Cancer
Center in New York and the University of Vienna in Austria presented the results
of the initial clinical trials with G3139.
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 many
human cancers, the BCL-2 protein is believed to be a major factor in inhibiting
apoptosis, or programmed cell death, and in contributing to resistance by those
cancers to treatment with anticancer drugs.
Researchers have proposed that G3139 could improve the treatment response of
many human cancers when combined with anticancer drugs - especially those
cancers that are resistant to anticancer drugs, a common clinical problem.
Currently, Genta is collaborating with major cancer research institutions in the
U.S., Canada and Europe in conducting several ongoing clinical trials to
determine the safety and utility of G3139 when combined with anticancer drugs
for treatment of common malignancies.
"The consistent clinical results reported at ASCO from multiple leading cancer
centers worldwide demonstrated patient tolerance, biologic activity and clinical
shrinkage of drug-resistant cancers, all major steps forward toward establishing
the 'proof of principle' for G3139 as a new modality for clinical cancer
therapy," said Kenneth G. Kasses, Ph.D., President and CEO of Genta.
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Summary of Presentations
Phase I-II Clinical Trial
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Non-Hodgkin's Lymphoma
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Dr. Justin Waters, Royal Marsden Hospital, U.K.
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Dr. Justin Waters and colleagues from the Royal Marsden Hospital reported the
results of a completed Phase I-II study in 21 patients with drug-resistant,
relapsed non-Hodgkin's lymphoma. G3139 was given alone as a slow infusion under
the skin over a two-week period. While most patients required change in the
infusion site due to local irritation from the subcutaneous administration, the
investigators reported that the drug was systemically tolerable with doses up to
4.1 mg/kg/day.
One patient with widespread disease obtained a complete remission, coupled with
a major improvement in cancer-related symptoms, a response now lasting for
almost three years with no other therapy. Two patients had minor responses
measured by CT scans and seven other patients had evidence for disease responses
measured by improvements in cancer-related symptoms or laboratory abnormalities.
The investigators also reported significant decreases in BCL-2 protein levels
when measured in clinical tumor samples from multiple sites of disease,
including blood, bone marrow and lymph nodes. "The results indicate that G3139
can produce the same type of biologic and therapeutic activity in humans that
had been observed in animal models," said Dr. Justin Waters, the co-investigator
for the study.
"Our data show that G3139 can lower BCL-2 protein levels as a treatment outcome,
demonstrated in multiple patients and from multiple sites of disease, and we
know a feasible dose and schedule for future clinical development. The multiple
responses of clinical disease parameters were especially rewarding, since these
patients entered the study with widespread, progressive disease despite prior
treatment with other chemotherapies," commented Dr.
Waters.
Based on results presented at ASCO, the investigators at the Royal Marsden
Hospital initiated a new Phase II protocol using G3139 combined with standard
chemotherapies in patients with relapsed, drug-resistant non-Hodgkin's lymphoma.
Phase I-II Clinical Trial
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Prostate and Kidney Cancer
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Drs. Michael Morris and Howard Scher, Memorial Sloan Kettering Cancer Center
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In the first report of G3139 results from a U.S. clinical trial, Drs. Michael
Morris and Howard Scher and colleagues from Memorial Sloan-Kettering Cancer
Center reported initial results from a Phase I-II study with G3139 as
single-agent therapy in patients with prostate and kidney cancer. The
investigators reported that the drug was generally well-tolerated with
outpatient intravenous infusions of doses up to 4.1 mg/kg/day, and some patients
received multiple cycles of therapy.
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The data provide a foundation for further clinical development of G3139 combined
with other standard chemotherapies, suggesting a rational, gene-specific therapy
for patients with hormone-resistant prostate cancer, and other common cancers
where drug resistance has been linked to increased BCL-2 protein levels.
Phase I-II Clinical Trial
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Advanced Malignant Melanoma
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Dr. Burkhard Jansen, University of Vienna, Austria
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Dr. Burkhard Jansen from the University of Vienna reported initial results from
a Phase I-II study in patients with malignant melanoma. Patients received both
G3139 and full dose dacarbazine (DTIC), a chemotherapeutic drug that is widely
used in melanoma, but with limited results when used as a single agent.
Dr. Jansen reported striking responses of metastatic lesions which were serially
monitored, including complete disappearance of some malignant tumors. "The
patients entering this study had disease that progressed through multiple prior
therapies, and yet dramatic improvements in some disease sites were clearly
documented after treatment with G3139 plus dacarbazine," said Dr. Jansen.
Dr. Jansen further noted, "We are encouraged by our results from correlative
studies, demonstrating activity of G3139 therapy to modify BCL-2 protein levels
and apoptosis in metastatic human cancer. Our results introduce a new, feasible
strategy for therapy of melanoma, and other solid tumors where BCL-2 has been
linked to drug resistance, which deserves formal evaluation in larger studies."
"In view of these well-documented, objective clinical data presented at ASCO,
and promising results from other ongoing clinical studies in patients with
prostate cancer and lymphoma, we are moving forward with our expanded clinical
programs with G3139 for patients with several common types of drug-resistant
malignancies." said Dr. Kasses.
Genta Incorporated 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
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
expressions 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
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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 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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