News

CritiTech announces new clinical trial site in Wichita, Kansas

July 28, 2009

FOR IMMEDIATE RELEASE
 
LAWRENCE, Kansas – Today David Johnston, Ph.D., CEO of CritiTech, Inc. announced that a second site has opened at the Cancer Centers of Kansas in Wichita, Kansas for its clinical trial of Nanotax® for the treatment of peritoneal cancers. The Phase I clinical trial of Nanotax® began enrolling patients in July, 2008 at the University of Kansas Cancer Center and will now expand to include patients of the Cancer Centers of Kansas in Wichita. “We are pleased to have an additional site in central Kansas so that more patients can be enrolled in the clinical trial without having to travel to Kansas City while allowing us to accelerate the development of this potentially important therapy” said Johnston.

Paclitaxel is a commonly used chemotherapy drug for ovarian cancer (one of several dangerous peritoneal cancers) but its side effects can be severe for many patients. "Nanotax® is a reformulation of paclitaxel that avoids the use of harsh solvents and we believe this clinical trial will show that Nanotax® has an improved side effect profile,” said Johnston. The American Cancer Society estimates that approximately 15,000 deaths occur each year in the U.S. from ovarian cancer, which causes more deaths than any other cancer of the reproductive system. The National Cancer Institute estimates that the five-year survival rate for all diagnosed patients with ovarian cancer is only 46 percent. In part this is due to the relatively advanced stage of the cancer at the time of diagnosis. Only nineteen percent of ovarian cancer cases are detected early. More information about this trial can be found at www.kansascancertreatment.org.

The underlying proprietary technology that resulted in the development of the drug Nanotax® was invented by researchers at the University of Kansas and licensed to CritiTech, a Lawrence-based pharmaceutical firm. CritiTech spent more than three years developing the drug product to FDA standards and performed all of the required pre-clinical testing necessary to gain approval to begin the clinical trial. CritiTech filed an investigational new drug (IND) application with the Food and Drug Administration (FDA) and is the sponsor of this clinical trial. Sam Campbell, Chairman of CritiTech said, “Launching a new drug is an enormous undertaking and would not have been possible without the cooperation and effort of Dr. Roy Jensen director of the University of Kansas Cancer Center, Drs Shaker Dakhil and Thomas Schulz of the Cancer Centers of Kansas and the Kansas Bioscience Authority (KBA) as well as all of CritiTech’s investors and staff plus the sustained support of our collaborators.” Beckloff Associates of Overland Park, Kansas guided CritiTech through the regulatory process and MRI of Kansas City, Missouri and Bayer Crop Science of Stillwell, Kansas performed many of the pre-clinical studies submitted as part of the IND application. Campbell has been raising equity capital for CritiTech for several years, and noted that some of the capital has been provided by MVA Capital Group out of Wichita and by Wichita Technology Ventures. Support has also been provided by KBA in researching critical aspects around areas of unmet clinical need and market details.

This Phase I trial is still accepting patients for enrollment. For more information about enrolling in this clinical trial contact Marilyn Labinski in the Clinical Trials Office of the University of Kansas Cancer Center at 913-588-4254.