Clovis Oncology, Inc. (NASDAQ: CLVS) today announced anticipated development milestones and financial guidance for 2013. Clovis currently has two clinical development programs and one drug discovery program underway.
A novel, oral, mutant-selective covalent inhibitor of EGFR mutations in non-small cell lung cancer (NSCLC), CO-1686 is currently the subject of an accelerated second-line development program. Clovis anticipates completing the following milestones in 2013 for CO-1686:
- Complete dose escalation portion of Phase I/II study to establish the dose and schedule;
- Initiate expansion cohorts of Phase I/II study to assess efficacy in second-line T790M+ NSCLC patients and in first-line mutant EGFR NSCLC;
- Initiate use of Roche Molecular Systems diagnostic test to identify T790M+ patients; and
- Prepare to initiate pivotal study in second-line T790M+ NSCLC patients in the first half of 2014.
RucaparibAn oral inhibitor of PARP-1 and PARP-2, rucaparib is being explored in ovarian and breast cancer patients with BRCA mutations and other DNA repair deficiencies. Clovis anticipates completing the following milestones in 2013 for rucaparib:
- Complete dose escalation portion of Phase I/II study to identify the monotherapy dose and schedule;
- Initiate expansion cohort of Phase I/II study to assess efficacy in selected ovarian cancer patients;
- Initiate Phase II biomarker validation in selected ovarian cancer patients to correlate clinical responses with patient genotype and inform the analysis of the pivotal trial;
- Advance development of diagnostic test with Foundation Medicine to identify patients with BRCA mutations and other DNA repair deficiencies most likely to respond to rucaparib;
- Initiate pivotal study of rucaparib as maintenance therapy in selected platinum-sensitive ovarian cancer patients in the second half of 2013.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV