TransMolecular Successfully Completes Phase I/II Clinical Trial With its Targeted Oncology Therapeutic
TransMolecular, Inc. announced that based on the favorable initial safety and tolerability profile of its anti-cancer therapeutic, 131I-TM-601 for recurrent glioma or metastatic brain cancer, it is initiating a Phase II multi-center North American clinical trial to include 66 patients with adult recurrent glioma. 131I-TM-601 is TransMolecular's anti-cancer therapeutic that incorporates a tumor targeting, biologically active and chemically synthesized 36 amino acid peptide derived from a naturally occurring protein found in scorpion venom that is conjugated with a medicinal radioisotope referred to as iodine 131.
The Phase I/II clinical trial included 18 recurrent high-grade glioma adult patients who were administered a single dose of 131I-TM-601 within 14 to 28 days after the recurrent brain tumors were surgically removed. Seventeen of the patients were diagnosed with glioblastoma multiforme, or GBM, one of the worst forms of glioma. Three sites participated in this multi-center trial. Median survival time for patients receiving 131I-TM-601 was 6.3 months compared to a median survival time of 4.6 months from published clinical studies of GBM with other treatments. Additionally, 11 out the 18 patients administered a single dose of 131I-TM-601 survived longer than six months, a notable improvement beyond the historical survival time for patients diagnosed with recurrent glioma and treated with conventional radiation and chemotherapy agents. Five glioma patients lived longer than one year and two patients out of 18 are still alive 21 months since surgery and treatment with a single dose of 131I-TM-601.
"The results from this Phase I/II clinical trial suggest that we have a well-tolerated, conveniently administered and promising anti-cancer agent against one of the deadliest forms of cancer -- recurrent GBM," stated Matthew A. Gonda, Ph.D., President and CEO. "We are encouraged by the favorable results from this Phase I/II clinical trial and after discussions with the U.S. Food and Drug Administration (FDA) we are preparing to enroll patients in a Phase II clinical trial that will be conducted at clinical sites throughout the United States and Canada."
According to the American Brain Tumor Association, it is estimated that 40,900 new cases of primary brain tumors will be diagnosed in 2004, of which approximately 19,000 plus cases will be diagnosed as malignant brain tumors, the rest are benign and curable. Moreover, it is estimated that during the year 2000, approximately 359,000 people in the United States were living after the diagnosis of a primary brain tumor. Unfortunately, a majority of people diagnosed and treated for malignant brain cancer experience recurrence of this deadly form of brain cancer and are faced with limited treatment options. Based on the unmet medical need in this patient population the FDA has granted this investigational drug Orphan Drug and Fast Track status.
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