I recently spoke with Dr. Alison O’Neill, VP of medical affairs at the company, for a February 2009 article in PharmaVOICE about trends in oncology drug development. Dr. O’Neill gave me an update on the program as well.
TransMolecular is now conducting several research projects with TM601 (chlorotoxin). Local delivery of a radiolabeled TM601 is being evaluated in recurrent malignant glioma, and the company has demonstrated that it can provide a targeted dose to the tumor without affecting normal cells.
“We have a Special Protocol Agreement with the FDA for the design of a Phase III study, and we are looking for partners to help us bring this forward,” she says.
The company, Dr. O’Neill says, has also completed Phase I studies of intravenous delivery of the radiolabeled compound and has made some initial steps toward Phase I/Phase II programs in solid tumor indications using IV delivery.
“Our sweet spot remains primary brain tumors, but there is certainly is a role for the drug in solid tumor indications well beyond that.”
When I wrote the initial story, the scorpion venom captured my imagination — something dangerous was being flipped on its head to give hope to those with few options. I thought of this company again last year after the death of Sen. Edward Kennedy.
Despite more than 25 years of research and a variety of chemotherapy, radiotherapy, and surgical approaches, the prognosis for these tumors has not changed significantly. Primary brain tumors remain one of the most aggressive and difficult to treat cancers.
The American Cancer Society estimates that 21,810 malignant tumors of the brain or spinal cord were diagnosed in the United States last year. About 13,070 people (7,420 men and 5,650 women) will die from these malignant tumors.
Please see page 12 in the digital edition of the February issue of PharmaVOICE for more from Dr. O’Neill and other industry experts about the challenges and opportunities in oncology drug development. Go to: