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news.The FDA has approved Innovive Pharmaceuticals' investigational new drug application for INNO-105, allowing the company to enter phase I clinical trials with the compound to treat adult patients with advanced solid malignancies.
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INNO-105 is a naturally occurring peptide that has recently demonstrated anti-tumor activity in a phase I pancreatic cancer study. Innovive Pharmaceuticals licensed the worldwide rights to the drug from The Hershey Medical Center, Pennsylvania State University earlier this year.
“INNO-105 has already shown great promise both in the laboratory and clinic. We now look forward to learning more about its safety profile and anti-tumor effects at higher doses and in a broader patient population,” said Steven Kelly, president and CEO of Innovive Pharmaceuticals.
INNO-105 inhibits cell growth and division by interacting with OGFr, a unique receptor found on the nuclear membrane of a wide range of malignant cells. Preclinical studies have demonstrated anti-tumor activity in numerous tumor types.
In addition, a phase I clinical study in pancreatic cancer patients was conducted at The Hershey Medical Center. The study findings were published in the March 2004 issue of the journal Anticancer Drugs.
Innovive expects to begin its phase I clinical trial in the fourth quarter of 2005.