REDWOOD CITY, CA, USA I June 18, 2014 I OncoMed Pharmaceuticals Inc. (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.
SOURCE: OncoMed Pharmaceuticals
Post Views: 34
REDWOOD CITY, CA, USA I June 18, 2014 I OncoMed Pharmaceuticals Inc. (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.
SOURCE: OncoMed Pharmaceuticals
Post Views: 34
