Clovis Oncology (NASDAQ:CLVS) announced today that it has dosed the first patient with its new hydrobromide salt tablet formulation of CO-1686 in its ongoing Phase I dose-finding portion of its Phase I/II clinical study. CO-1686 is the Company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer (NSCLC) in patients with initial activating mutations as well as the dominant resistance mutation T790M.
“We believe this is a very important step in the development of CO-1686, given the improved pharmaceutical qualities of the hydrobromide salt formulation,” said Patrick Mahaffy, President and CEO of Clovis Oncology. “Over the next several months we will transition all current patients on the original capsule form of CO-1686 to this new formulation, and, of course, continue to enroll new patients as well.”
Data presented at ASCO in June from a Phase I study of CO-1686 in healthy human volunteers treated with the hydrobromide salt tablet form of CO-1686 showed improved exposures and reduced PK variability compared with the free base capsule formulation, which has been used to date in the Phase I study in patients with NSCLC. Specifically, in the Phase I study in healthy volunteers, the tablet form of CO-1686 demonstrated a 2 to 3-fold improvement in absorption and a 4-fold reduction in exposure variability relative to the free base capsule formulation.
With the introduction of the tablet formulation, the Company recommences dose escalation in the Phase I dose-finding portion of the trial and expects to identify the recommended Phase II dose (RP2D) by the end of this year. Upon identification of the RP2D, the Company will initiate the Phase II expansion cohorts to assess efficacy in 2nd line T790M+ non-small cell lung cancer (NSCLC) patients and in 1st line EGFR NSCLC patients. The 2nd line cohort is expected to initiate by year-end and the 1st line cohort in early 2014. Additionally, the Company expects to initiate the registration study in 2nd line T790M+ NSCLC patients in the second half of 2014 and a Phase I study in Japan in early 2014.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the prospectus supplement and related prospectus for this offering as well as Clovis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2012 and its other reports filed with the Securities and Exchange Commission.