Brief Summary

This is the Blaze Bioscience expanded access program for its investigational drug tozuleristide intended for patients with life-threatening diseases or conditions who have exhausted approved treatment options and are unable to participate in a clinical trial involving the investigational drug tozuleristide.

Detailed Description

1. Contact Information: A licensed treating physician may submit questions or requests on

behalf of a patient regarding expanded access to tozuleristide to be evaluated in

accordance with Blaze Bioscience company policies. Physician Expanded Access Requests

should be submitted in writing to expandedaccess@blazebioscience.com and include

"Expanded Access Request" in the subject.



2. Request Procedures:



1. General Criteria: Blaze Bioscience will evaluate and respond to each Expanded

Access Request individually and on a case-by-case basis. Criteria Blaze Bioscience

will use in its evaluation of whether to grant Expanded Access Request include:



1. Adequate supply of the investigational drug tozuleristide must be available

above and beyond the supply needed for Blaze Bioscience clinical trials;



2. There is sufficient clinical data to identify an appropriate dose of the

investigational drug;



3. There is a good understanding of the patient's clinical situation and

investigational drug proposed use for surgery including the proposed

fluorescence detection device;



4. All available therapeutic approaches for the patient's disease have been

exhausted by the patient and their physicians;



5. The investigational drug is considered an "eligible investigational drug"

under Section 561(B)(2) of the FDCA at the time of the Expanded Access

Request;



6. Providing the investigational drug is compliant with all applicable rules and

laws;



7. Appropriate Institutional Review Board/Ethics Committee and FDA authorization

requested expanded access has been obtained;



8. Treating physician understands and is willing to be responsible for ensuring

that the patient informed consent requirements are met; and



9. Treating physician understands and is willing to be the holder of a treatment

IND with FDA.



2. Timing of acknowledgement: Blaze Bioscience endeavors to acknowledge requests

within ten (10) business days of receipt of an Expanded Access Request.



3. Clinical trials: Blaze Bioscience lists its active clinical trials on

clinicaltrials.gov. Before granting an Expanded Access Request for tozuleristide,

written confirmation by the treating physician that the patient is not eligible for

an active Company clinical trial is needed prior to consideration of the Expanded

Access Request.

Available
Individual Patients

Drug: Tozuleristide
Other Name: BLZ-100
Other Name: Tumor Paint

Eligibility Criteria

Inclusion Criteria: - Undergoing surgery for suspected or confirmed tumor - Not eligible for current clinical trials of tozuleristide

Eligibility Gender
All
Contacts

Blaze Bioscience Expanded Access
206-535-8144
expandedaccess@blazebioscience.com

Blaze Bioscience Info
info@blazebioscience.com

Blaze Bioscience Inc.
NCT Number
Intervention Name
Tozuleristide