EXHIBIT 99.1
EDG Capital, Inc. Announces the Filing of an Investigational New Drug
Application for Colloidal ^32P Phosphorus and Macroaggregated Albumin
NEW YORK, January 19, 2001 - EDG Capital, Inc., a developer of nuclear
pharmaceuticals for therapeutic use in the treatment of cancer, today announced
that it has filed an Investigational New Drug (IND) application with the Food
and Drug Administration (FDA) to investigate the use of Colloidal ^32P
Phosphorus and Macroaggregated Albumin (^32P/MAA) in the treatment of solid
tumors.
Jack Schwartzberg, Chief Executive Officer, President and Chairman of EDG
Capital, stated: "The filing of the IND for the ^32P/MAA combination therapy
represents a major milestone in the development of this product for the
treatment of pancreatic and brain tumors. The filing of this IND brings us a
significant step closer to our goal of commercializing this combination product
and patented procedure."
In November 2000, the FDA performed an inspection of the Center for Molecular
Medicine, the facility where the ^32P/MAA studies are being performed. The
Center for Molecular Medicine is a clinical research group under management
contract with EDG Capital's subsidiary, Isotope Solutions, Inc. While the
results of the inspection were favorable, the FDA asked Dr. Stanley Order, the
principal investigator, to file an IND for its review. On November 27, 2000, Dr.
Order filed an IND to permit the use of the ^32P/MAA combination in clinical
studies of pancreatic and brain tumors. Since that time, the FDA has given Dr.
Order permission to continue the studies of ^32P/MAA in pancreatic cancer.
Before enrollment of patients into the brain cancer study can proceed, the FDA
has asked for assurance that the ^32P and MAA products meet a specific purity
requirement (specifically, bacterial endotoxin levels) for use in the brain.
Isotope Solutions, Inc. is currently working with its suppliers to provide
assurance to the FDA that the two products meet the FDA's requirement and
anticipates that the issue will be resolved in the near future.
"We are extremely pleased that the FDA has permitted us to continue the
pancreatic cancer studies," Mr. Schwartzberg noted. "We are working closely with
our suppliers to address the endotoxin requirement so that we can proceed with
enrollment of patients into the brain cancer study as soon as possible," he
added.
About EDG Capital, Inc. Through its wholly-owned subsidiary, Isotope Solutions,
Inc., EDG Capital is engaged in the research, development and testing of nuclear
pharmaceuticals for therapeutic use in the treatment of the most lethal forms of
cancer. Isotope Solutions, Inc.'s research is conducted by internationally
renowned clinicians that have entered into management contracts with Isotope
Solutions, Inc.
Legal Disclaimers: This press release may contain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934. Investors are cautioned that
forward-looking statements are inherently uncertain. Actual performance and
results of operations may differ materially from those projected or suggested in
the forward-looking statements. The forward-looking statements contained herein
represent EDG Capital, Inc.'s judgment as of the date of this release, and EDG
Capital, Inc. cautions investors not to place undue reliance on such statements.
CONTACT: EDG Capital, Inc., New York
Shragie David Aranoff
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Vice President
516/222-5154; [email protected]
or
Patricia Amerman
Rubenstein Associates, Inc.
212/843-8049; [email protected]
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