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Intralytix, Inc. develops bacteriophage-based products to treat disease-causing bacteria and their conditions. We conduct clinical trials of our investigational products as required by regulatory authorities to assess their safety and efficacy to gain regulatory approval.

Intralytix understands there are times that seriously ill patients may exhaust other treatment options and may seek to obtain expanded access (or “compassionate use”) for our products. Only a qualified, licensed physician, who meets the requirements in this policy, may request information on the availability of expanded access to Intralytix's investigational products. Intralytix will review each request on a case-by-case basis only for individual patients meeting the criteria in the policy.


The purpose of this policy is to describe the requirements for expanded access to Intralytix investigational products


This policy applies to expanded access for an Intralytix investigational product that is not approved by the appropriate regulatory authorities for use in the country where it is intended to be used.


Intralytix investigational products, not administered under an approved clinical trial protocol, must be used in accordance with Intralytix’s policies and procedures, and all applicable country-specific, regional and local laws and regulations.

Patient Eligibility Criteria:

To be eligible for expanded access, patients must meet the following criteria, including but not limited to:

  • Suffer from a serious or immediately life-threatening bacterial-based disease or condition that may potentially be targeted by our investigational product;
  • Have unsuccessfully undergone appropriate standard treatments where adequate alternative treatment is unavailable or does not exist, and is verified by a treating physician;
  • Are not eligible to participate in an ongoing clinical trial of the investigational product, which also may include a lack of access due to geographic limitations;
  • Have a disease or condition where there is sufficient evidence of an expected benefit from the use of the investigational product and where the benefit outweighs any known or anticipated risks;
  • Provide consent to receive the investigational product; and
  • Other criteria, which may be applied depending on the complexity and diversity of each individual case.

Investigational Product Criteria:

The requested investigational product must meet the following criteria, including but not limited to:

  • Have sufficient evidence that the investigational product will target the cause of the disease or condition with an acceptable safety profile for the individual patient;
  • Availability of the investigational drug under expanded access will not negatively impact or delay the conduct of clinical trials or other regulatory activities; and
  • An adequate supply of the investigational drug is currently available.

Treating Physician Criteria And Responsibilities:

The treating physician must agree in writing to:

  • Being appropriately licensed and fully qualified to administer the investigational product;
  • Have the expertise and resources for monitoring, managing and reporting any adverse events during and after the course of treatment;
  • Obtain patient consent and all applicable regulatory approvals (e.g., FDA, IRB);
  • Administer the investigational product;
  • Follow any applicable country-specific, regional and/or local regulatory requirements related to providing an investigational product under expanded access;
  • Comply with Intralytix policies, procedures and requirements, such as medical criteria, safety reporting, appropriate use of the investigational product and protection of intellectual property.


For Patients:

To avoid delays, requests for expanded access to Intralytix’s investigational products may only be made by a qualified, licensed physician, who may make the request on the patient’s behalf.

For Treating Physicians:

All requests for expanded access for an individual patient must be submitted by the patient’s treating physician. Physicians meeting the above requirements may request additional information about Intralytix’s expanded access policy by email at:


Intralytix will evaluate all requests in a fair and equitable manner, and all decisions are final. We will use our best efforts to address each request within 5 business days after receipt.

Each request will be considered on a case-by-case basis for individual patients only. Requests made only by the treating and qualified physician may be submitted to

Each investigational product is different and may target and/or only be appropriate for treatment of specific bacterial-based diseases or conditions. If one investigational product is granted expanded access for a specific patient, it does not mean that it is/will be available for other requests or patients whose situations may differ, or that any other investigational product will be available under this policy.


For more information on Intralytix’s clinical trials, search “Intralytix” at

Additional information on expanded access in the United States can be found at:

The publication of this policy does not guarantee access to any Intralytix investigational product. Intralytix may revise this policy at any time at its own sole discretion.