Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and thyroid cancer. Our mission is to develop innovative cellular therapies to transform cancer treatment worldwide.
We believe that the best way for patients to access any investigational therapy is through well controlled clinical trials. However, we recognize that not all potential patients in the U.S. will be able to access investigational products through a clinical trial and therefore may seek access to investigational products prior to FDA approval and in compliance with relevant US federal and state regulations, for life threatening, chronic, or seriously disabling conditions when patients have exhausted all other options. We understand the need for expanded access programs (may also be called compassionate use, early access, special access, or by other names depending on the country from which the access is being requested) and we recognize the importance of having an appropriate policy.
A number of factors consistent with the U.S. Food and Drug Administration and other regulatory agencies’ guidelines should be taken into account when considering expanded access. In general, expanded access to investigational or unlicensed products may be considered when all of the following criteria are met:
- The illness must be serious or life-threatening, with no other satisfactory treatment options (such as approved products or enrolling clinical trials);
- The patient meets any other important medical criteria established by the medical experts working on the product development program;
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information. If approved, physicians must agree to participate in our safety monitoring and reporting requirements, and must follow FDA safety reporting regulations;
- We must be able to provide an investigational product in a fair and equitable manner so that there is adequate manufacturing capacity for ongoing development programs;
- Granting expanded access must not compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients.
The CoupledCAR technology that ICT is currently developing is distinct from many other investigational therapies under development for oncology indications. ICT’s investigational agents are individually made, one-by-one, for each individual patient in our clinical trials using each individual patient’s own white blood cells as a starting material. There is no readily available supply of any of our investigational agents. Manufacturers with the necessary technical capacity to produce such investigational therapies are limited in number in the US and indeed globally. Due to these constraints, all manufacturing capacity ICT has available is dedicated to our ongoing clinical trials and no additional capacity is currently available for potential patients outside of our sponsored clinical trials. Therefore, ICT is not currently making any of its investigational products available on an Expanded Access basis prior to regulatory approval anywhere in the world. Should additional manufacturing capacity beyond that needed to support our clinical trials become available in the future, ICT will revisit this policy.
ICT may reconsider making one or more of its investigational products available through an Expanded Access Program in the future. Requests for expanded access use must be received from the patient’s treating physician in the United States on behalf of the patient.
As authorized by the 21st Century Cures Act, ICT may revise this Expanded Access Policy at any time. The posting of this policy by ICT shall not serve as a guarantee of access to any specific investigational product by any individual patient.
If you have additional questions, please speak with your treating physician or contact ICT at email@example.com.