SCOTTSDALE, Ariz. (Oct 5, 2009) - A new drug designed to "seek and destroy" common cancers such as breast, prostate, endometrial, pancreatic, ovarian, skin and testicular cancers is being tested at TGen Clinical Research Services (TCRS) at Scottsdale Healthcare.
The Phase 1 clinical trial will help determine if EP-100 is safe and effective for use among patients with solid cancer tumors, with fewer side effects than chemotherapy or radiation treatment.
TCRS is a partnership of the Translational Genomics Research Institute (TGen) and Scottsdale Healthcare. The partnership allows molecular and genomic discoveries made by TGen and others around the world to reach the patient bedside in the Virginia G. Piper Cancer Center at Scottsdale Healthcare as quickly as possible through clinical trials with agents directed at specific targets in patients' tumors.
According to Ramesh K. Ramanathan, MD, principal investigator for the trial in Scottsdale, the drug is a membrane-disrupting peptide (tMDP) designed to "seek and destroy" cancer cells by targeting those with excessive luteinizing hormone releasing hormone (LHRH) receptors.
Excessive LHRH receptors are found in a wide range of cancers, including breast, prostate, endometrial, pancreatic, ovarian, skin and testicular cancers.
Mike Janicek, MD, a Gynecologist Oncologist who practices at the Virginia G. Piper Cancer Center at Scottsdale Healthcare said, "I am looking forward to participating in the study with EP100, especially for ovarian and uterine cancer patients. Often patients with advanced cancer will need new therapies and a targeted treatment like EP100 is the next frontier of research."
The study is designed to evaluate the safety of EP100 and will enroll as many as 36 adult patients with solid tumors whose tumor biopsies indicate that they have excessive LHRH receptors.
EP-100 will be administered intravenously for three out of four weeks. Once the maximum tolerated dose has been established, additional subjects with specific diagnoses of either breast, ovarian, endometrial, pancreatic or prostate cancer will be enrolled. EP-100 is produced by Esperance Pharmaceuticals of Baton Rouge, La., and was culled from a range of drugs tested at TGen Drug Development Services (TD2) in Scottsdale.
"It brings with it a killer, a toxin. It's a way of targeting a toxin to the cancer tumor cells,'' said Dr. Steve Gately, president and chief scientific advisor at TD2. "Our goal would be to find that set of patients who are highly responsive; who have the greatest benefit. We'd like to accelerate the government approval for that agent.''
The clinical trials could show that EP-100 is effective with certain types of cancer, Dr. Gately said. "Perhaps there is a genetic context under which certain patients may be more responsive. We want to find those patients.''
Dr. Hector Alila, president of Esperance, said EP-100 has the potential to offer an improved safety and effectiveness over existing therapies, such as radiation or chemotherapy.
"Preclinical studies of EP-100 demonstrated this candidate's efficacy across multiple indications in oncology, including aggressive cancers known to be resistant to the current standards of care and, importantly, studies of EP-100's mechanism-of-action support that it targets and selectively kills cancer cells without harming normal cells," Dr. Alila said.
About the Virginia G. Piper Cancer Center at Scottsdale Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare offers diagnosis, treatment, research, prevention and support in its facilities at the Scottsdale Healthcare Shea Medical Center, attracting patients from across Arizona and the U.S. Groundbreaking cancer research is conducted through its Scottsdale Clinical Research Institute and TGen Clinical Research Service. Scottsdale Healthcare is the not-for-profit parent organization of the Scottsdale Healthcare Shea Medical Center, Scottsdale Healthcare Osborn Medical Center and Scottsdale Healthcare Thompson Peak Hospital, Virginia G. Piper Cancer Center, Scottsdale Clinical Research Institute and Scottsdale Healthcare Foundation. For additional information, please visit www.shc.org.
The Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. TGen is affiliated with the Van Andel Research Institute in Grand Rapids, Michigan. For more information, please visit: www.tgen.org.
TGen Senior Science Writer
About Esperance Pharmaceuticals
Esperance Pharmaceuticals, Inc. is developing a new class of highly potent targeted anticancer drugs using its Cationic Lytic Peptide (CLYP™) platform technology. These drug candidates, called targeted membrane-disrupting peptides (tMDPs), consist of a ligand component that binds to extracellular receptors on the cancer cell and a potent cytolytic peptide component that kills the cancer cell. Targeted MDPs, which are positively charged, specifically bind only to cancer cells that express the target receptors on their surfaces and interact with the negatively charged membranes of the cancer cells resulting in disruption of the cell membrane and causing the cancer cells to die by cell lysis. The drug candidates selectively kill cancer cells, including cells known to be resistant to chemotherapeutic drugs, without harming normal cells. In addition to EP-100, Esperance Pharmaceuticals has three other drug candidates in preclinical stages. The Company was founded on patented technology discovered by scientists at Louisiana State University. Founding investors include the Louisiana Fund I, Research Corporation Technologies and Themelios Ventures, LP--a venture fund managed by the principals of VCE Capital Partners, LLC. Additional investors include the Louisiana Technology Fund and private investors. More information can be found at www.esperancepharma.com.
Hector Alila, Ph.D.
President and Founder
Esperance Pharmaceuticals, Inc.
MacDougall Biomedical Communications