EXPANDED ACCESS / COMPASSIONATE USE POLICY
Ultimovacs ASA is a pharmaceutical company developing novel immunotherapies against cancer. Our mission is to extend and improve the life of patients by directing the immune system against the core of cancer.
The following is Ultimovacs’ global expanded access policy for UV1, an investigational therapeutic cancer vaccine intended to treat solid tumors.
Expanded Access / Compassionate Use program
Currently, Ultimovacs does not have any investigational new drug available via Expanded Access (also known as “Compassionate Use”) program.
Ultimovacs acknowledges the significance of early access. Per regulatory requirements, expanded access program must not interfere with the clinical development of the drug. For that reason, it is our priority to expeditiously establish safety and efficacy of our drugs in controlled clinical trials; this would facilitate positive review and approval by the Regulatory Agencies in order to make them commercially available to all appropriate patients.
Ultimovacs is currently unable to offer expanded access program and we trust that participation in one of our clinical trials is the most pragmatic way to get treatment with UV1 in a controlled setting.
Clinical trials are performed in order to evaluate the safety and efficacy of investigational new drugs in specific populations. Participation in clinical trials authorized by the U.S. Food and Drug Administration, European and other national competent authorities is the best way for patients to get treatment with an investigational new drug for their disease.
Treating physicians, patients and/or caregivers interested in learning more about Ultimovacs’ investigational new drugs currently undergoing clinical trials can find more information on the company’s website, linked here.
Clinicaltrials.gov contains additional information about these trials.
For physicians or healthcare providers interested in more information, please contact email@example.com.
This policy by Ultimovacs shall not serve as a guarantee of access to any specific investigational new drug by any individual patient. As authorized by and in accordance with the 21st Century Cures Act, Ultimovacs may revise this posted expanded access policy at any time.