Synthesized Scorpion Venom Basis for New Brain Cancer Drug Clinical Trials to Begin Editor`s note (10/16/2002) - trial is now open!
Posted on: 10/16/2002
Synthesized Scorpion Venom Basis for
New Brain Cancer Drug
Clinical Trials to Begin
Title: Phase I/II Open Label, Single-Dose Study of Intracavitaty
Administered 131 I-TM-601 in Patients with Recurrent High-grade Glioma
Principal Investigator: Adam Mamelak, M.D.
LOS ANGELES and BIRMINGHAM, Ala., July 1, 2002 - Brain surgeons at two major
medical centers-City of Hope in Los Angeles and the University of Alabama at
Birmingham (UAB) -will soon begin treating patients suffering from glioma,
one of the most deadly forms of brain cancer, with an investigational new
drug called 131I-TM-601, being developed by TransMolecular, Inc., a
Birmingham-Ala.-based neuroscience biotechnology company.
131I-TM-601 is a radiopharmaceutical containing a synthetic version of a
substance derived from scorpions called chlorotoxin. The study will evaluate
the safety and tolerability of a single dose of 131I-TM-601, as well as
overall tumor response rate in the initial study group of 18 patients.
In pre-clinical studies, TransMolecular scientists determined that
131I-TM-601 was able to extend survival in a mouse model that mimicked human
brain tumors. TM-601, based on chlorotoxin sequences, has been shown to be
non-toxic in animal studies. The Food and Drug Administration approved
TransMolecular's IND application to begin a Phase I/II clinical study of the
drug in humans in January 2002.
"Therapeutic options for glioma patients are rather limited," said Matthew
A. Gonda, Ph.D., TransMolecular president and CEO. "We have now harnessed
the power of Mother Nature by incorporating a natural product into our
anti-cancer drug. 131I-TM-601 uses sequences from chlorotoxin that have
evolved to precisely locate and bind to their receptor, which is abnormally
expressed on tumor cells, but not on normal cells. It's like molecular
surgery. The chlorotoxin sequences are the guidance system that delivers a
radioactive payload to its target, precisely killing the tumor cells. We are
very pleased to be working with two nationally recognized medical centers
whose expertise in brain cancer makes them leaders in this field."
Doctors at City of Hope Cancer Center and the UAB Brain Tumor Treatment and
Research Program are seeking adult patients with recurrent glioma who have
not had prior treatment with gene therapy, brachytherapy, radiosurgery or
implants of polymers containing chemotherapeutic agents. Patients must also
be eligible for resection of the recurrent tumor. Eighteen patients will be
monitored over a six-month period during the study. Prospective patients or
their physicians should contact UAB at 205-975-0438 or City of Hope at
626-359-8111, ext. 63033 or ext. 62329.
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. There is a need for safe,
more effective treatments for glioma.
ABOUT CITY OF HOPE
City of Hope Cancer Center is one of the world's leading research and
treatment centers for cancer and other life-threatening diseases, including
diabetes and HIV/AIDS. A pioneer in the fields of bone marrow
transplantation and genetics, City of Hope is a National Cancer
Institute-designated Comprehensive Cancer Center. For more information,
ABOUT TRANSMOLECULAR, INC.
TransMolecular, Inc. founded in 1996, is a privately held neuroscience
biotechnology company committed to discovering, developing and
commercializing novel and proprietary products to diagnose and treat
disorders and diseases of the central nervous system having inadequate
pharmaceutical alternatives, including cancer and pain. The company's
corporate office and R&D laboratory are located in Birmingham, Ala. For more
information, visit www.transmolecular.com.
ABOUT THE UNIVERSITY OF ALABAMA AT BIRMINGHAM
The UAB Health System is internationally known for its expert physicians,
medical education, groundbreaking research and strong commitment to
compassionate, personal care for patients. UAB is a National Cancer
Institute-designated Comprehensive Cancer Center and the university's Brain
Tumor Treatment & Research Program is devoted to the care and treatment of
patients with brain tumors and neurologic complications of systemic cancers.
The program at UAB has been in existence for over 12 years and during this
period has developed into one of the largest such programs in the country.
For more information, visit www.uab.edu.
ADAM MAMELAK, M.D., CITY OF HOPE, IS AVAILABLE FOR INTERVIEWS. CALL
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