PharmaGap Inc., a biotech company focused on developing novel peptide therapeutics for the treatment of cancer, today announced that liposomal formulations of its cancer drug met and surpassed expectations for three integral key elements for clinical trials: potency, pharmacokinetic profile, and therapeutic index.
The company noted that roughly 250,000 new cancer cases annually in the U.S. stem from cancers with origins in the peritoneal cavity. An itraperitoneal injection is a delivery method designed to send liposomal peptides to tumor sites for certain cancers, including ovarian, pancreatic, colorectal, gastric and liver.
PharmaGap will first focus on definitive efficacy testing on ovarian cancer for first clinical trial application, though the company will continue to investigate and develop liposomal peptides to explore further applications.
Dr. Ken Sokoll, vice president of Clinical Development and chief operating officer for PharmaGap, detailed the company’s liposomal formulations.
“Rapid metabolism and elimination of peptide drugs is known to be a major factor contributing to the failure of peptide drugs. Our ability to overcome this problem using these new liposomal formulations and demonstrating that we have viable formulations when administered by both the intravenous and intraperitoneal routes will be key factors in achieving success for our drug compounds,” Dr. Sokoll stated in the press release.
The company reported that peptide half-life increased from a range of 0.4 to 0.7 for unformulated peptides to approximately eight hours using intravenous administration and to approximately 40 hours using intraperitoneal administration; liposomal associated peptide was detectable up to 72 hours post administration, which indicates that peptide remains in circulation for extended periods of time.
Rats that were administered liposomes via intraperitoneal injection were observed for 72 hours. The company said the results of this observation indicate that liposomal formulations would be well-tolerated over a wide dosing range (10-40 mg/Kg). PharmaGap anticipates that the results would provide a wide therapeutic index (the dosing range between effective dose and the dose at which toxic effects are seen) for drug administered by this route.
For more information visit www.pharmagap.com
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