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Naturally occurring substance from scorpions provides basis for new drug
BIRMINGHAM, Ala., June 1 /PRNewswire/ -- TransMolecular, Inc., a
biotechnology company focused on cancer drug research, today announced the
initiation of a phase II open-label, multiple-dose study of intracavitary
administered 131I-TM-601 in adult patients with recurrent high-grade glioma.
The company plans to have more than 12 sites participating in the study.
Sites currently participating include City of Hope National Medical Center,
Duarte, CA; Florida Hospital, Orlando, FL; Northwestern University, Evanston,
IL; Saint Louis University, St. Louis, MO; Saint Mary's Health Care, Grand
Rapids, MI; and University of Alabama at Birmingham, Birmingham, AL.
"On the strength of the results of our phase I/II data that showed good
safety and tolerability, we are very excited to advance this program into
phase II development. We are proud to be working on a product that could fill
a need for safe, more effective treatment for those who suffer from this
devastating disease," said Lyle A. Hohnke, Ph.D., chairman of the board and
acting CEO of TransMolecular and a partner at Tullis-Dickerson & Co., Inc., an
investor in the company.
131I-TM-601 is a radiopharmaceutical containing a synthetic version of
chlorotoxin, a substance derived from scorpion venom. Chlorotoxin, or TM-601,
specifically seeks out and binds to a receptor expressed on tumor cells, but
not on normal cells. TM-601 acts as the guidance system that very effectively
delivers a radioactive payload to its target, precisely killing the tumor
cells and minimizing collateral damage to normal cells. 131I-TM-601 has
received Orphan Drug and Fast Track Development Program status from the FDA.
The Phase II study will be conducted in two parts, both involving adult
patients with recurrent high-grade glioma. The first sequence is an open-
label dose escalation, multi-dose study. Four cohorts of patients will be
treated postoperatively at escalating dose levels until the Maximum Practical
Dose (MPD) is reached or until determination of the Maximum Tolerated Dose
(MTD). After the MPD or MTD is reached, this dose will be expanded in the
second trial sequence.
The second trial sequence is an open-label, randomized study in a larger
group of patients. Patients will receive either a three- or six-dose
treatment cycle at the previously determined MPD or MTD to evaluate the
safety, time to disease progression and survival rates after treatment.
The company anticipates that in the first sequence of the study, three
patients will be enrolled in each dose cohort. An additional group of three
patients may be enrolled at a given dose based on safety. In the second
sequence, a total of 54 patients will be randomized in two equal groups
treated with either one cycle of three or one cycle of six repeat doses of
intracavitary 131I-TM-601.
ABOUT GLIOMA
Glioma is highly invasive, sending cancerous cells throughout the brain
and spinal cord. Surgical techniques fail to eradicate the tumor and other
adjuvant therapies are inadequate. Brain cancers are among the most difficult
and expensive cancers to treat. About 36,000 primary brain tumors are reported
in the U.S. each year; of these, more than 17,000 are diagnosed with high-
grade gliomas. About half of these patients die within the first year,
according to the American Cancer Society.
ABOUT TRANSMOLECULAR, INC.
TransMolecular, Inc. is a privately held biotechnology company committed
to discovering, developing and commercializing novel and proprietary products
to diagnose and treat diseases having inadequate pharmaceutical alternatives,
including cancer and pain. Research on TransMolecular's product pipeline
based on a small peptide derived from scorpion venom that will be useful in
treating a wide variety of cancers is continuing in Birmingham, Alabama, where
the company's corporate offices and research laboratories are located. More
information can be found at http://www.transmolecular.com .
Contact: Lyle A. Hohnke, Ph.D.
Chairman of the Board of Directors
Phone: 205-870-4811
SOURCE TransMolecular, Inc.
Web Site: http://www.transmolecular.com