Cmed working with BioMed Valley Discoveries on Rare Cancer Therapy Phase II trial
Written by Ian Macholl
BioMed Valley Discoveries, a clinical stage biotechnology company, announced yesterday it had received Fast Track designation from the US Food and Drug Administration (FDA) for investigation of the ERK inhibitor ulixertinib (BVD-523) with Cmed as the contract research organization (CRO) for the Phase IIb study.
Ulixertinib is a treatment for patients with non-colorectal, solid tumors that harbor specific BRAF mutations. BioMed Valley Discoveries (BVD) has launched a Phase II multi-center study of ulixertinib for patients with advanced malignancies harboring these atypical (non-V600) BRAF alterations or a MEK alteration.
BVD and Cmed are also collaborating with Strata Oncology to identify and enrol study patients.
David Chao, PhD, president and CEO of BVD, commented “We are pleased with the receipt of Fast Track designation for ulixertinib and delighted to collaborate with Cmed and Strata to develop this promising first-in-class ERK inhibitor.”
Stephanie Langouet, Cmed Chief Operations Officer added “We are delighted to be working with BioMed Valley Discoveries on this expedited trial for ulixertinib. With both organizations focused on advancing medical innovations for the benefit of patients, integrating our medical and clinical expertise with our state-of-the-art technology was essential to provide sites and Biomed Valley Discoveries with a more advanced and modern-day approach to clinical trial management’’.
This patient population is rare (<1% of cancers), however a strong scientific rationale exists to treat patients harboring putatively activating MEK1/2 alterations with ERK inhibition.
BioMed Valley Discoveries is a clinical stage biotechnology company focused on addressing unmet medical needs in a variety of therapeutic and diagnostic areas. BVD was established in 2007 to advance new medical innovations to improve the lives of patients with difficult-to-treat diseases.
The study (NCT04488003) is expected to begin enrollment in Q3 2020.
Press release by BioMed Valley Discoveries