xCures announces the launch of a Compassionate Use program for ulixertinib (BVD-523)
SAN FRANCISCO, Sept. 28, 2020 /PRNewswire/ -- xCures, a clinical study platform provider, announces the US Food and Drug Administration (FDA) granted their IND for an intermediate Expanded Access Program (EAP) for the ERK inhibitor ulixertinib (BVD-523).
Ulixertinib is being developed by BioMed Valley Discoveries (BVD), a clinical stage biotechnology company, as a treatment for patients with MAPK pathway aberrant cancer, including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK, mutations.
The EAP is open across the United States to adolescent and adult cancer patients who cannot access an open clinical trial for the investigation of ulixertinib (BVD-523).
"xCures prospective real-world evidence generation capability transforms managed access programs such as the ulixertinib expanded access program by making them an efficient way for physicians and patients to gain access to promising therapies when clinical trials are not an option," says Mika Newton, CEO of xCures, Inc. "xCures' programs uniquely capture high-value evidence related to the safety and efficacy from this expanded set of patients."
This intermediate-sized expanded access program (NCT04566393) is currently open and available for physicians interested in treating their patients. Physicians can reach out to firstname.lastname@example.org for more information. Patients can register and find more information at enroll.xcures.com/uli-eap or receive additional information via xCures patient advocacy partner Cancer Commons (www.cancercommons.org).
About ulixertinib (BVD-523):
About Expanded Access:
About the Program:
About BioMed Valley Discoveries (BVD):
Operating since 2007, BioMed Valley Discoveries was established by Jim Stowers Jr., founder of the asset management firm American Century Investments, and his wife Virginia, to advance new medical innovations to improve the lives of patients with difficult-to-treat diseases. BVD is owned by a supporting organization of the Stowers Institute for Medical Research, a non-profit, basic biomedical research organization. Since 2000, the endowment of the Stowers Institute has received over $1.5 billion in dividend payments from American Century. The Institute has invested a portion of its endowment in BVD, whose profits accrue to the benefit of the Institute. For more information, visit https://www.biomed-valley.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/xcures-announces-the-launch-of-a-compassionate-use-program-for-ulixertinib-bvd-523-301139076.html