- Subject: Magainin Begins Phase I Human Clinical Testing of...
- From: AOL News <AOLNews@aol.com>
- Date: Tue, 16 Dec 1997 07:51:37 EST
- Organization: AOL (http://www.aol.com)
<HTML><PRE><FONT COLOR="#000000" SIZE=5><B>Magainin Begins Phase I Human
Clinical Testing of Squalamine for Cancer Also Presents Preclinical Data in
Breast Cancer
<FONT COLOR="#000000" SIZE=3></B> PLYMOUTH MEETING, Pa., Dec. 16
/PRNewswire/ -- Magainin Pharmaceuticals Inc. (Nasdaq: MAGN) today announced
the commencement of Phase I human clinical testing of squalamine, an
angiogenesis inhibitor, for the treatment of patients with solid tumors. The
first patient was administered squalamine at the Cancer Therapy and Research
Center, San Antonio, TX, under the direction of Dr. Gail Eckhardt. A second
Phase I trial is expected to begin shortly at the Lombardi Cancer Center,
Georgetown University under the direction of Dr. Michael Hawkins.
The objective of the phase I clinical trials will be to assess the safety
and pharmacokinetics of intravenously administered squalamine in cancer
patients. This information will be used to design subsequent efficacy trials
in individuals with advanced stage malignancies using squalamine alone and in
combination with commonly administered chemotherapeutic agents. It is
expected that phase I studies of squalamine will involve a total of about 50
patients.
On December 3, 1997, at the 20th Annual San Antonio Breast Cancer
Symposium, Dr. Daniel von Hoff and colleagues at the Institute for Drug
Development reported that squalamine, used in combination with Cytoxan,
increased the number of long-term cures achieved with Cytoxan alone, and also
significantly delayed the time of progression for recurring primary tumors, in
preliminary studies utilizing a mouse model of human breast cancer. These new
studies are consistent with previous work, which has shown that squalamine
inhibits the growth of melanoma, breast, lung and brain tumors in animal
models. Squalamine has been shown to both retard the growth of primary tumors
and reduce the spread of metastases to other parts of the body.
At the 88th annual meeting of the American Association of Cancer Research
(AACR) held earlier this year, Dr. Joan Schiller and colleagues at the
University of Wisconsin demonstrated in mouse models that squalamine improved
the therapeutic efficacy of drugs such as cisplatin against human lung cancer.
Previously, Dr. Henry Brem and colleagues from Johns Hopkins demonstrated that
squalamine was effective in animals against certain cancers, such as brain and
rectal tumors. And, in data to be presented in an upcoming AACR Meeting, Dr.
Beverly Teicher and colleagues from the Dana Farber Cancer Center will report
that squalamine reduces metastatic spread of lung cancer in mice when used
with other chemotherapeutic agents. These animal studies provide the basis
for considering squalamine in the treatment of cancers such as breast, lung
and brain, either alone or in combination with existing chemotherapy.
"Squalamine is an impressive antiangiogenic agent which has had
significant antitumor activity in our animal studies," said Dr. Henry Brem,
Professor of Neurosurgery and Oncology and Director of Neurosurgical Oncology
at The Johns Hopkins University School of Medicine in Baltimore, Maryland.
"Based on our laboratory findings, we believe squalamine has enormous
potential for providing a new therapeutic alternative for patients with
cancer."
Squalamine was discovered in 1992 in the body tissues of the dogfish shark
by a team led by Michael Zasloff, M.D., Ph.D., Executive Vice President of
Magainin. It is the first of a novel class of naturally occurring
pharmacologically active molecules (the "aminosterols") under development at
Magainin as human therapeutics. Squalamine has been shown to be a new type of
inhibitor of angiogenesis. Angiogenesis is the process of budding and growth
of new blood vessels from existing blood vessels under the stimulus of a
variety of growth factors. Squalamine inhibits the growth of tumor-induced
new blood vessels in animal systems, and also reduces the spread of tumor
metastases. Metastatic disease is often the primary cause of death in cancer
and involves the process of tumor cell escape from the primary tumor through
blood vessels to distant sites in the body. Collaborators at Johns Hopkins
and Harvard, along with Company scientists, have shown that squalamine
prevents several known growth factors from stimulating endothelial cells to
assemble into capillaries. Squalamine blocks the action of these growth
factors by inhibiting salt- and acid-regulating pumps on the endothelial cell
required for capillary formation.
Magainin Pharmaceuticals Inc. is a biopharmaceutical company engaged in
the development of medicines for serious diseases. The Company's development
efforts are focused on anti-infectives, oncology and pulmonary and allergic
disorders.
This announcement contains certain forward-looking statements that are
subject to risks and uncertainties. Such statements reflect management's
current views and are based on certain assumptions. Actual results could
differ materially from those currently anticipated as a result of a number of
factors, including, but not limited to, the risks and uncertainties discussed
under (I) "Management's Discussion and Analysis of Financial Condition and
Results of Operations" in the Company's 1996 Annual Report to Shareholders, as
filed with the Securities and Exchange Commission, as well as Item 1 of the
Company's Annual Report on Form 10-K for the year ended December 31, 1996 as
filed with the Securities and Exchange Commission, and (II) "Risk Factors" in
the October 20, 1997 Prospectus in respect of Registration Statement no.
333-38271 on Form S-3 filed by the Company with the Securities and Exchange
Commission. The Company disclaims any intent or obligation to update these
forward-looking statements.
CO: Magainin Pharmaceuticals Inc.
ST: Pennsylvania
IN: MTC
SU:
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