TransMolecular's 131I-TM601 Successfully Localizes to Multiple Tumor Types without Targeting Healthy Tissue

-Clinical Study Discussed in Oral Presentation at the Society for Nuclear Medicine Annual Meeting-

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 17, 2009 - TransMolecular, Inc. today announced the presentation of data from a completed clinical study utilizing radiolabeled TM601, demonstrating highly specific tumor uptake of intravenously administered 131I-TM601 in several different primary and metastatic solid tumors, including glioma, melanoma, lung, prostate, colon, breast, and pancreatic cancers. Additionally, the study demonstrated that 131I-TM601 localized to tumors across the blood-brain barrier. The data were highlighted in an oral presentation at the Society for Nuclear Medicine (SNM) Annual Meeting. TM601 is a novel, wholly synthetic peptide found to have robust anti-angiogenic activity in neovascular diseases, including cancer and ophthalmic disease, as well as tumor-targeting capabilities.

“This study provides very specific dosimetry data for intravenous 131I-TM601, which provides the basis for dose escalation of the compound in subsequent trials. The study also confirms clinical data presented at this year's ASCO meeting that supported the potent tumor-targeting potential of intravenous 131I-TM601 across multiple tumor types, and again demonstrates its ability to cross the blood-brain barrier,” said Robert Radie, President and Chief Executive Officer of TransMolecular. “The highly selective localization and uptake of 131I-TM601 to tumor cells demonstrates the potential of the TM601 tumor-targeting platform as a means of delivering other cancer therapies directly to tumors throughout the body, without affecting surrounding healthy tissue.”

Abstract 150149 Details

The abstract details the dosimetry evaluation of intravenous 131I-TM601 to determine tumor and normal organ uptake in patients with recurrent or refractory somatic and/or cerebral metastatic solid tumors. Results are presented from 20 patients who received an intravenous imaging test dose of 10mCi/0.2mg 131I-TM601, followed by five whole body scans and one SPECT scan, to evaluate tumor localization. Patients showing tumor-specific uptake continued in the study and received an intravenous treatment dose of 30 mCi/0.6mg 131I-TM601.

According to the study, 7/7 glioma patients, 6/7 melanoma patients and 4/6 patients with a variety of other metastatic tumors demonstrated tumor-specific uptake without dose-limiting toxicities. The study also confirmed prior results that have shown that intravenously administered 131I-TM601 can localize to tumors across the blood-brain barrier. Mean radiation dose to the tumor was 1.4 cGy/mCi for glioma and melanoma patients (n=13), with tumor volume defined by post-contrast MRI.

About TM601

TM601 is a novel, wholly synthetic peptide found to have robust anti-angiogenic activity in neovascular diseases, including cancer and ophthalmic disease.

For oncology applications, TM601 is highly specific and selective in targeting both primary tumors and metastases in the periphery and in the central nervous system. TM601 has the unique properties of highly specific tumor cell binding, uptake and internalization. Clinical studies confirm that TM601 targets and binds to a receptor expressed on a wide range of tumor cells, but not on normal, healthy cells. TransMolecular is expanding the TM601 tumor-targeting platform to deliver a range of therapeutic agents, including novel and currently used chemotherapeutic agents, as well as RNAi molecules, to tumor cells.

Most recently, the effects of TM601 on neovasculature were validated in animal models of ophthalmic disease, including wet age-related macular degeneration (AMD).

About TransMolecular, Inc.

TransMolecular, Inc. is committed to discovering and developing novel therapeutic products that help patients combat cancer and neovascular diseases. TransMolecular's product pipeline is based on the TM601 platform, a novel synthetically derived polypeptide, which has both highly specific tumor binding properties and anti-angiogenic therapeutic properties. More information can be found at www.transmolecular.com.

This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with litigation, clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, intellectual property, and other factors.

Contact: TransMolecular: Robert Radie, 617-995-3050 x 303 President and CEO or Media: MacDougall Biomedical Communications Jennifer Conrad, 781-235-3060 jconrad@macbiocom.com

Posted: June 2009

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