Brief Summary

This is the Blaze Bioscience expanded access program for its investigational drugtozuleristide intended for patients with life-threatening diseases or conditions who haveexhausted approved treatment options and are unable to participate in a clinical trialinvolving 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,Tumor Paint

Eligibility Criteria

Inclusion Criteria:

- Undergoing surgery for suspected or confirmed tumor

- Not eligible for current clinical trials of tozuleristide

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Contacts

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

Blaze Bioscience Info
info@blazebioscience.com

Blaze Bioscience Inc.
NCT Number