Clovis Oncology, Inc. (Nasdaq: CLVS) announced today that it has reached the target enrollment in its pivotal LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 in metastatic pancreatic cancer. CO-101 is the Company’s lipid-conjugated form of the anti-cancer drug gemcitabine.
LEAP is an international, randomized, controlled 360-patient, pivotal trial designed to demonstrate that CO-101 improves overall survival versus gemcitabine in hENT1-low metastatic pancreatic cancer patients. LEAP is the first study to utilize a companion diagnostic in metastatic pancreatic cancer, and enrollment required collection of metastasis biopsies prior to randomization, necessary to allow comprehensive assessment of tumor hENT1 expression as a modifier of treatment outcome. The study is being conducted at 99 centers in 15 countries. Top-line overall survival data from LEAP are expected in the fourth quarter of 2012. If the trial is successful, Clovis intends to file for approval in the US and EU by mid 2013. CO-101 has an orphan drug designation in the United States and European Union for the treatment of pancreatic cancer.
“This is the first registration study that attempts to bring personalized medicine to patients with pancreatic cancer, and our team and our investigators did a superb job in completing enrollment in only 19 months,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “If successful, this trial has the potential to be practice-changing in the management and treatment of metastatic pancreatic cancer, a disease for which only limited options are available today.”
The hENT1 HypothesisThe standard first-line treatment for patients with metastatic pancreatic cancer is gemcitabine, given either as monotherapy or in combination with other cytotoxic agents. For gemcitabine to kill cancer cells, it must enter through specific membrane transporters on the surface of the cells, and human Equilibrative Nucleoside Transporter 1 (hENT1) has been shown to be the dominant transporter for gemcitabine. Tumor cells with low hENT1 expression have been shown to be resistant to gemcitabine therapy in vitro and in vivo, and retrospective analyses from multiple published studies of gemcitabine in pancreatic cancer have shown a strong correlation of overall survival outcomes to hENT1 expression, with patients that have low hENT1 expression receiving little to no benefit from gemcitabine therapy. LEAP is the first trial that seeks to prospectively demonstrate this correlation using a fully validated IHC assay, with a pre-defined “cut-off” of hENT1-high and hENT1-low. About CO-101 CO-101 (also known as CP-4126) is a novel, patented, lipid-conjugated form of the anti-cancer drug gemcitabine. In contrast to gemcitabine alone, CO-101 was designed to enter cancer cells regardless of hENT1 expression. CO-101 is intended to address the unmet need of patients with pancreatic cancer whose tumors express low amounts of hENT1 and therefore, are expected to be resistant to standard gemcitabine therapy. CO-101 may also be applicable in other tumor types where gemcitabine is commonly used.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
24/7 market commentary from Jim Cramer and 20+ veteran Wall Street gurus. Get access to the latest trading ideas on stocks, options, and ETFs as well as a real-time forum to see the pros exchanging their investment ideas.
- Jim Cramer + 20 Wall Street pros
- Intraday commentary & news
- Real-time trading forum
- Actionable trade ideas
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV