REDWOOD CITY, Calif., June 18, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), reported on continued discussions begun last week with the U.S. Food and Drug Administration (FDA) regarding the company's FZD8-Fc (OMP-54F28) Phase 1 program. The FDA's Division of Oncology Products 1 (DOP1) agreed with OncoMed's voluntary halt, and today informed the company that, as a formality, a partial clinical hold has been placed on Phase 1 clinical trials of FZD8-Fc. The partial clinical hold on FZD8-Fc will remain in effect until OncoMed provides DOP1 with requested additional data and proposed protocol amendments have been submitted to and concurred with by the FDA. OncoMed also reported that the FDA reiterated its concurrence with the company's plan to continue dosing of a patient in the single-agent Phase 1a FZD8-Fc clinical trial who has remained on treatment for greater than 390 days progression free without significant drug-related adverse effects.
"As we expected, the FDA concurred with our voluntary halt to Phase 1 studies. We appreciate the timeliness of the FDA's response to our initial reports of mild-to-moderate bone adverse events in patients in our vantictumab and FZD8-Fc Phase 1 trials. We will continue to analyze the data in hand with study investigators and academic bone expert advisors to assess the adverse events observed in these trials and develop revised clinical trial protocols. We remain committed to evaluating FZD8-Fc and vantictumab as possible therapies for cancer patients and today's discussion with DOP1 continued to advance the process of determining the best path forward," stated Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed.
On June 13, 2014, OncoMed announced its decision to voluntarily halt enrollment and dosing in its Phase 1 vantictumab and FZD8-Fc Wnt pathway programs as a precautionary measure based on reported incidents (13% and 5%, respectively) of mild-to-moderate bone adverse events. Later that day, vanticumab was placed on partial clinical hold following the company's discussion with a different Division of Oncology Products (DOP2).
OncoMed plans to submit amended protocols to the FDA and subsequently to clinical sites for both the vantictumab and FZD8-Fc programs. These amendments are expected to incorporate modified dosing regiments, updated risk mitigation measures and revised enrollment criteria. Enrollment and dosing of new patients in the Phase1b trials for both programs are expected to resume once amendments complete the process of review by the FDA and approval by the study sites' institutional review boards (IRBs).
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells (CSCs). OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch 2/3, OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-Fzd7, OMP- 18R5), and FZD8-Fc (OMP-54F28), which target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed has two other antibodies in preclinical development, anti-DLL4/anti-VEGF bispecific (OMP-305B83) and anti-RSPO3 (OMP-131R10), with Investigational New Drug filings planned for late 2014 or early 2015. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline. Additional information can be found at the company's website: www.oncomed.com.
To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, 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, including OncoMed's expectations regarding the ability of OncoMed to advance vantictumab and FZD8-Fc in clinical development; the submission and content of amended protocols for the vantictumab and FZD8-Fc Phase 1 trials; the acceptability of OncoMed's amended vantictumab and FZD8-Fc Phase 1 protocols by the Food and Drug Administration and institutional review boards; the resumption of enrollment and dosing of new patients in the Phase 1b trials for vantictumab and FZD8-Fc; the continuation of dosing of a patient in the Phase 1a FZD8-Fc trial; the conditions under which the partial clinical holds on vantictumab and FZD8-Fc will be lifted; and the timing of Investigational New Drug filings for OncoMed's anti-DLL4/anti-VEGF bispecific and anti-RSPO3 antibodies. Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future 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 preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; OncoMed's dependence on its collaboration partners, including Celgene, GSK and Bayer, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's dependence on the development and marketing efforts of its partners for the commercial success of its partnered product candidates; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to validate, develop and obtain regulatory approval for companion diagnostics; OncoMed's ability to achieve market acceptance and commercial success of its product candidates once regulatory approval is achieved; OncoMed's ability to discover, develop and commercialize additional product candidates; the ability of competitors to discover, develop or commercialize competing products more quickly or more successfully; OncoMed's dependence on its Chairman and Chief Executive Officer, its Chief Scientific Officer, its Chief Medical Officer and other key executives; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate OncoMed's patents or proprietary rights; and the ability of OncoMed's proprietary rights to protect its technologies and product candidates. OncoMed 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 OncoMed's business in general, see OncoMed's Annual Report on Form 10-K for the fiscal year ended December 31, 2013, filed with the Securities and Exchange Commission (SEC) on March 18, 2014, and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2014, filed with the SEC on May 8, 2014.
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Source:OncoMed Pharmaceuticals, Inc.