Dr. Michael Roberts featured in article on Scottsdale Healthcare’s cancer drug testing.
In early testing, the experimental drug has an exciting stealth quality, said Dr. Ramesh Ramanathan, principal investigator at the cancer center. "It's using a very new technology to introduce the drug into the cancer cell," Ramanathan said.
"One of the big problems with cancer drugs is, sometimes, it is difficult to get the drug into the cancer cell. And, if that doesn't happen, the drug won't work."
The drug was developed by Tekmira Pharmaceuticals Corp. of Vancouver, British Columbia.
Researchers want to enroll up to 52 patients in three centers across the United States.
The drug is called TKM-PLK1, and it targets a protein called polo-like kinase 1 (PLK1) that causes tumor cells to reproduce. It prevents the tumor from completing cell division, resulting in death of the cancer cell.
The new technology is called siRNA, and it is a synthetically engineered compound that can access the membrane of the cancer cell and stop production of the protein that cancer cells need to grow.
"It's like a stealth attack on the cancer cell," Ramanathan said.
The drug is administered intravenously.
TKM-PLK1 has been shown in pre-clinical animal studies to selectively kill cancer cells while sparing healthy cells.
Laboratory research has shown the compound may be effective in treating colorectal, breast and some lung and ovarian cancers.
These diseases collectively affect more than 500,000 new patients each year in the United States, Scottsdale Healthcare executives said.
Mark J. Murray, Tekmira's president and CEO, has said interim data on the trial could be reported in the second half of 2011.
Enrollment at the Virginia G. Piper Cancer Center is under way, with the center seeking patients diagnosed with advanced, solid, cancerous tumors that are not responding to traditional and current treatments.
No patients have yet been enrolled.
This phase of the study is focused on side effects, safety and proper dosing of the drug. Secondary objectives and those of later trials will measure tumor response. It's too early to determine whether the drug will affect length or quality of life in a cancer patient.
The Phase 1 clinical trials offered over 10 years at the cancer center, often in collaboration with the Phoenix-based Translational Genomics Research Institute, are valuable, said Dr. Michael Roberts of Arizona Oncology, which has locations throughout Arizona. He was not involved in the study.
"Some drugs go through Phase 1, go to Phase 2 and Phase 3 and eventually get approved," Roberts said. "This is hugely important for the patients who have very little options, either because they've gone through traditional therapies or because of complications because of side effects and they can't do (traditional therapy) anymore."
The partnership will be an advantage in the study, he added.
"Sometimes, a drug goes through Phase 1 and winds up being a drug of great benefit to a number of people. (For example) the toxicity can be more readily observed. Scottsdale Healthcare and T-Gen are really good and helping a lot of drugs get moving along."
Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center may call 480-323-1339, toll free at 877-273-3713 or e-mail firstname.lastname@example.org.