From: Subject: Synthetic version of scorpion venom delivers radioactive iodine to malignant brain tumors Date: Sun, 30 Jul 2006 10:19:53 +0200 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C6B3C1.B2AA67D0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.2869 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C6B3C1.B2AA67D0 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.eurekalert.org/pub_releases/2006-07/cmc-svo072106.php Synthetic version of scorpion venom delivers = radioactive iodine to malignant brain tumors

Public = release date:=20 28-Jul-2006
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Contact: Sandy Van
sandy@prpacific.com
800-880-23= 97
Cedars-Sinai Medical=20 Center

Synthetic version of scorpion venom delivers = radioactive iodine=20 to malignant brain tumors

Los Angeles -- (EMBARGOED UNTIL JULY 28, 2006 AT 6:00 P.M. EDT) -- A = new=20 method of delivering a dose of radioactive iodine =96 using a man-made = version of=20 scorpion venom as a carrier =96 targets deadly brain tumors called = gliomas without=20 affecting neighboring tissue or body organs. After a Phase I clinical = trial=20 conducted in 18 patients showed the approach to be safe, a larger Phase = II trial=20 is underway to assess the effectiveness of multiple doses.

Adam N. Mamelak, M.D., a neurosurgeon at Cedars-Sinai Medical = Center's Maxine=20 Dunitz Neurosurgical Institute, led the Phase I trial and is first = author of an=20 article in the August of the Journal of Clinical Oncology.

The key ingredient is TM-601, a synthetic version of a peptide, or = protein=20 particle, that naturally occurs in the venom of the Giant Yellow Israeli = scorpion. TM-601 binds to glioma cells and has an unusual ability to = pass=20 through the blood-brain barrier that blocks most substances from = reaching brain=20 tissue from the bloodstream.

"We're using the TM-601 primarily as a carrier to transport = radioactive=20 iodine to glioma cells, although there are data to suggest that it may = also slow=20 down the growth of tumor cells. If studies continue to confirm this, we = may be=20 able to use it in conjunction with other treatments, such as = chemotherapy,=20 because there may be a synergistic effect. In other words, TM-601's = ability to=20 impede cancer growth could allow us to reduce the dose of chemotherapy = to=20 achieve a therapeutic effect," said Mamelak, who serves as co-director = of the=20 Pituitary Center at Cedars-Sinai.

About 17,000 Americans are diagnosed with gliomas each year. The = tumors are=20 extremely aggressive and deadly, with only eight percent of patients = surviving=20 two years and three percent surviving five years from time of diagnosis. = Even=20 when surgery is performed to remove a glioma, some cancer cells = invariably=20 remain behind and proliferate.

"Despite advances in surgical technology, radiation therapy and=20 cancer-killing drugs, length of survival has remained virtually = unchanged for=20 patients with gliomas," said Keith L. Black, M.D., director of the = Maxine Dunitz=20 Neurosurgical Institute and interim chair of Cedars-Sinai's Department = of=20 Neurosurgery. "Only in the recent past have we begun to discover some of = the=20 molecular, genetic and immunologic mechanisms that enable these deadly = cancer=20 cells to evade or defy our treatments, and we are developing innovative=20 approaches, such as this one, that capitalize on these revelations."

Patients who consented to participate in the Phase I study first = underwent=20 tumor-removal surgery. Fourteen to 28 days later, a single, low dose of=20 radioactive iodine (131I) attached to TM-601 was injected through a = small tube=20 into the cavity from which the tumor had been removed.

Although TM-601 had been tested in earlier laboratory and animal = experiments,=20 it had never been given to humans. Therefore, the primary objective of = this=20 study was to document that 131I-TM-601 could be administered to humans = safely.=20 In addition, the researchers sought to begin to assess the drug's = anti-tumor=20 effect and dosing standards. Six patients agreed to receive additional = doses at=20 one of three different levels (.25 mg. of TM-601, .5 mg. of TM-601, and = 1 mg. of=20 TM-601, each carrying the same amount of iodine).

"In this first human trial, treatment of patients with recurrent = high-grade=20 glioma with a single intracavitary dose of 131I-TM-601 was well = tolerated to the=20 maximum dose =85. Very few adverse side effects occurred during the = initial 22-day=20 observation period, suggesting the dosing level of peptide used in this = study is=20 safe and well-tolerated in humans," the article states.

While median length of survival for all patients was 27 weeks, two = patients,=20 women in their early 40s, had a "complete radiographic response," = meaning there=20 was no evidence of residual tumor according to magnetic resonance = imaging scans.=20 The patients were still alive beyond 33 and 35 months after surgery, = despite the=20 low dose of TM-601 and radiation levels that were below expected = therapeutic=20 levels.

Analyses also showed that most of the radioactivity delivered by the = drug=20 left the region within 24 hours of administration. That which lingered = was=20 "tightly localized to the tumor cavity and surrounding regions, = suggesting=20 discrete binding to the tumor." The drug was eliminated primarily = through the=20 urine, with radiation doses to the thyroid and other vital organs = remaining=20 extremely low and harmless.

Mamelak said TM-601 binds to tumors other than gliomas, and this = therapy will=20 be studied in a variety of tumor types. He conducted this study with = colleagues=20 from City of Hope Cancer Center in Duarte, the University of Alabama at=20 Birmingham, St. Louis University in Missouri, and TransMolecular, Inc., = of=20 Birmingham. TransMolecular also provided funding for the study.

###

Citation: Journal of Clinical Oncology, August, 2006, "Phase I = Single-Dose=20 Study of Intracavitary Administered 131I-TM-601 in Adults with Recurrent = High-Grade Gliomas"

The first of eight hospitals in California whose nurses have been = honored=20 with the prestigious Magnet designation, Cedars-Sinai Medical Center is = one of=20 the largest nonprofit academic medical centers in the Western United = States. For=20 18 consecutive years, it has been named Los Angeles' most preferred = hospital for=20 all health needs in an independent survey of area residents. = Cedars-Sinai is=20 internationally renowned for its diagnostic and treatment capabilities = and its=20 broad spectrum of programs and services, as well as breakthroughs in = biomedical=20 research and superlative medical education. It ranks among the top 10=20 non-university hospitals in the nation for its research activities and = is fully=20 accredited by the Association for the Accreditation of Human Research = Protection=20 Programs, Inc. (AAHRPP). Additional information is available at http://www.cedars-sinai.edu/.

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