 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
Press Release
New trials set for drug for cancer of pancreas
by David Wichner, Arizona Daily Star
Tucson, Arizona, March
3, 2005 - A Tucson company based on University of Arizona drug research
has launched a second round of clinical trials on a new medicine to treat
pancreatic cancer - one of the deadliest forms of cancer.
AmpliMed™ Inc. has begun enrolling patients for a "Phase I/II" clinical
trial study of its drug candidate, Amplimexon™, in combination with another
chemotherapy drug.
The company also is wrapping up Phase I clinical trials begun in 2003 to determine
safe dosages of Amplimexon as a stand-alone drug, AmpliMed Chairman and CEO
Robert Ashley said.
The new trials will test Amplimexon in combination with gemcitabine - marketed
under the brand name Gemzar by Eli Lilly & Co. - to treat patients with
previously untreated advanced pancreatic cancer.
Pancreatic cancer afflicts more than 30,000 patients in the United States
each year, and fewer than 15 percent of patients with advanced stages of the
disease survive a year or longer.
Amplimexon works by disrupting mitochondria - the energy-producing factories
of the cancer cell - resulting in the leakage of toxic substances that kill
cancer cells.
The drug's relatively low toxicity makes it a good candidate for use with
other medications, Ashley said, noting that initial results of the Phase I
study show that it is better tolerated by patients than first expected.
"The big advantage of our drug is it doesn't kill bone-marrow cells,
or at least we don't have any evidence that it does," Ashley said.
Those findings raise hopes that Amplimexon and gem- citabine could be given
in full doses, avoiding the cumulative toxicity of some drug combinations,
said Dr. David Alberts, director of the Arizona Cancer Center at the UA and
vice president of business development for AmpliMed.
"We're excited about it, because we anticipate being able to give full
doses of both drugs," Alberts said.
The Phase I study, conducted at the Arizona Cancer Center, the Virginia Piper
Cancer Center in Scottsdale and an affiliate of the John Wayne Cancer Center
in Santa Monica, Calif., will be wrapped up later this year, Ashley said.
The new study is being conducted at five research sites, including the Anschutz
Cancer Pavilion of the University of Colorado Cancer Center and the University
of Michigan Cancer Center. The Arizona Cancer Center is finalizing a contract
to hold part of the trials here, Alberts added.
Because pancreatic cancer does not respond well to available treatments, Amplimexon
likely will be eligible for "fast track" approval status from the
Food and Drug Administration, Ashley said.
If all goes well in current and subsequent trials, AmpliMed could receive
FDA approval of Amplimexon as soon as 2008, Ashley said.
AmpliMed has attracted about $15 million in venture capital funding since
2003.
###
For additional information about AmpliMed Corporation, please contact Mr. Wayne Morrison at (520) 529-1000.
AmpliMed™, Amplimexon™ and Amplizone™, are United States trademarks of AmpliMed Corporation.