Intensity Therapeutics (the Company) is the developer and drug manufacturer for a novel investigational drug product, INT230-6. This new product is in early clinical development and uses intratumoral injection for its delivery modality.
The drug is being used to treat solid tumor cancers. Intensity Therapeutics has chosen not to offer EA and will not accept EA requests for its products at this time.
The justification of the restriction on expanded access is as follows:
- The Company’s ability to conduct clinical trials is limited. Offering EA under any setting at this time will impact on the Company’s ability to execute its trials including EA trials.
- There is insufficient safety and efficacy data to determine risk-benefit for a variety of cancers.
- The organization does not have the time, personnel, sufficient investigational drug product and other resources to offer EA on a fair and equitable basis.
- The Company’s investigational drug products require special handling, transportation, use training, special radiographic imaging and administration.
For further information on this policy please see below:
- Information for expanded access requests:
- Ian B. Walters, M.D.: firstname.lastname@example.org
- Procedures for making an EA request to the company:
- For the reasons stated above there is no EA permitted at this time. No requests can be granted. Our recommendation is to contact the study sites to see if the patient qualifies for the on-going clinical trials. For study sites visit www.clinicaltrials.gov and use the identifier 03058289.
- Anticipated time it will take the company to acknowledge receipt of a request:
- The Company will acknowledge the receipt of a request within 1 week; however, for the reasons noted in procedures above, all responses for EA will be denied.
- General criteria used to evaluate and respond to a request
Since there is no EA program at this time there are no criteria for evaluation. Sites will evaluate patients based on the study inclusion and exclusion criteria.
Intensity Therapeutics, Inc. Expanded Access Policy Version 1
April 15, 2019