PBRC Cancer drug on track to human trials; researchers awaiting “go ahead.” - 06.02.2009

All preclinical work is done: multiple animal experiments in dosages and strengths to measure potential effectiveness and toxicity; lab experiments to unravel the exact means by which the drug works; and refinements in fabricating the drug to make sure it is pure and reliable.

Now the U.S. Food and Drug administration is examining the application to allow the first human trials of a kind of cancer drug that is so new there is not an existing class to put it in.

Based on a technology developed by a team led by Center researcher Dr. William Hansel, along with specialists at the Ag Center and LSU, Esperance scientists created the new drug (EP-100) which seeks out individual cancer cells and destroys them, both in a main tumor and in any other tissue or organ to which the cancer cells may have spread.

The drug showed such early promise in the lab, investors both within and outside Louisiana formed a company to fund the necessary procedures and experiments needed for FDA approval to start human trials. Esperance Pharmaceuticals, inc. is now developing the drug, has submitted its data to the FDA and expects to have an answer soon. That answer could be to proceed with the first human trials.

Hector Alila, Ph.D, President and Founder of Esperance, said because the drug type is so new, he can’t predict the answer from the FDA, but his company is committed to getting this drug to human trials. If the answer from the FDA is to clarify, conduct more experiments, show more detail, or any other request, he is prepared. But being first with a drug has its advantages. Dr. Alila will be able to suggest the name of the class the drug creates, and be well ahead of the game in that class with future drugs.

“I call this a guided missile,” Alila said, “It seeks out and destroys only cells that have the target on them.”
That target, he said, is called a receptor, and it is a unique molecule on the surface of a cancer cell that allows only a specific molecule to bind. His drug uses that molecule to find the receptor, bind to the cell, then deliver a killer compound that destroys the cell membrane.”

The drug is designed to seek out receptors that were discovered on the surfaces of a wide variety of cancers like breast , ovarian , prostate, pancreatic, endometrial and skin cancers. Alila said the first human trials will likely be in women with ovarian cancer. And the trial, dubbed “Phase 1” by the FDA would serve one purpose: find out if the drug is safe to be taken by a human. Phases 2 and 3 would follow, which would determine not only more about safety, but also how well it works to actually treat cancer.

Dr. Hansel, a well-known reproductive biologist when he arrived at the Center several years ago from Cornell University, embarked on a new line of cancer treating research while here, making the discovery of this technology in his eighties. He recently celebrated is 90th birthday and arrives on campus every day, continuing to lead the lab research that created this technology and is likely to create more.

For More Information Contact:
Glen Duncan
225-763-2599
glen.duncan@pbrc.edu
http://www/pbrc.edu