Cytopia claims success in early-stage anti-cancer drug trial

By Melissa Trudinger
Wednesday, 28 May, 2003

Melbourne drug discovery company Cytopia has claimed its lead anti-cancer compounds were active in vitro against acute lymphoblastic leukaemia (ALL), a common form of childhood cancer.

The studies were carried out by the Children's Cancer Institute of Australia for Medical Research (CCIA) using primary cell cultures from childhood leukaemia patients, and according to Cytopia's chief scientific officer Dr Andrew Wilks, work is continuing to confirm the activity of the compounds in an in vivo model of childhood ALL. In addition, the compounds showed activity against cells resistant to Vincristine, a commonly used chemotherapeutic for ALL.

"We're really excited about this one," he said. "We're just waiting for the final proof of concept in vivo."

According to Dr Richard Lock, of the leukaemia biology program at the CCIA, Cytopia's compounds were very impressive in comparison to others tested. "The activity against Vincristine-resistant cells is particularly significant as these patients have a very poor prognosis," Lock said.

"We are delighted that Cytopia has agreed to fund a continuation of this research at CCIA -- dependent on the results of further testing, this breakthrough could offer hope to many patients in the future."

The result means that Cytopia's lead compounds are active against at least three different types of cancer, including hormone-refractory prostate cancer, chronic myeloid leukaemia and ALL. Wilks said the company was continuing to evaluate the use of the drug on other cancer types.

Pre-clinical program continuing

Meanwhile, Cytopia is pushing forward with its pre-clinical program, planning to select at least one compound to take into clinical trials from the six or so that have been tested in vivo.

"We now have one very promising candidate. I believe we'll end up in the clinic with this one," Wilks said. "Whether it is exactly the same molecule that is used for each application, I'm not sure, but they will be closely related."

According to Wilks, the last pre-clinical steps required before clinical trials can be started include formal GMP synthesis of the molecule, which he says is largely underway, and an extensive period of GLP toxicology.

"We expect to be in Phase I clinical trials early next year," he said. Among the decisions yet to be made are the clinical indication to be tested in the first instance. "We will probably roll out a series of trials, quite possibly beginning with leukaemia."

Cytopia CEO Dr Kevin Healey said the combined potential market for the drug candidate was worth more than $US1 billion.

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