Press Release
Press Release
Exelixis to Initiate Phase 1 Clinical Development of XL092, First New Compound to Enter the Clinic from Reinitiated Discovery Efforts
– Phase 1 dose-escalation trial follows filing of IND in
“Exelixis is building a pipeline of diverse investigational medicines
behind cabozantinib through in-house drug discovery activities and
targeted in-licensing,” said
The multi-center phase 1 clinical trial is designed to evaluate the pharmacokinetics, safety and tolerability of XL092. The trial is divided into dose-escalation and expansion phases. The dose-escalation phase of the trial will enroll patients with advanced solid tumors, with the primary objective of determining a dose for daily oral administration of XL092 suitable for further evaluation. Assuming positive data from the initial phase of the trial, the expansion phase is designed to further explore the selected dose of XL092 in individual tumor cohorts, where safety, tolerability, and initial clinical activity would be evaluated.
“Supported by revenues from the global cabozantinib franchise,
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Founded in 1994,
Exelixis Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: the potential of XL092 to
address tumor-induced immunosuppression; Exelixis’ plan to use data from
the upcoming phase 1 clinical trial to determine the potential for
further development of XL092; Exelixis’ expectations for the clinical
progress of XL092 and continued maturation of other earlier-stage
molecules currently in development; and Exelixis’ plans to reinvest in
its business to maximize the potential of the company’s pipeline,
including through targeted business development activities and internal
drug discovery. Any statements that refer to expectations, projections
or other characterizations of future events or circumstances are
forward-looking statements and are based upon Exelixis’ current plans,
assumptions, beliefs, expectations, estimates and projections.
Forward-looking statements involve risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in the forward-looking statements as a result of these risks
and uncertainties, which include, without limitation: risks and
uncertainties related to regulatory review and approval processes and
Exelixis’ compliance with applicable legal and regulatory requirements;
the potential failure of XL092 to demonstrate safety and/or efficacy in
a phase 1 clinical trial and be deemed suitable for future evaluation;
uncertainties inherent in the drug discovery and product development
process, including evolving regulatory requirements, slower than
anticipated patient enrollment or inability to identify a sufficient
number of clinical trial sites; the costs of conducting clinical trials;
Exelixis’ dependence on third-party vendors for the development,
manufacture and supply of XL092; Exelixis’ ability to protect its
intellectual property rights; market competition; changes in economic
and business conditions; and other factors affecting Exelixis and its
development programs discussed under the caption “Risk Factors” in
Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (
View source version on businesswire.com: https://www.businesswire.com/news/home/20190212005852/en/
Source:
Susan Hubbard
EVP, Public Affairs & Investor Relations
Exelixis,
Inc.
650-837-8194
shubbard@exelixis.com
Hal Mackins
For Exelixis, Inc.
415-994-0040
hal@torchcomllc.com