AVB-114 is an autologous investigational product under evaluation in Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II; a prospective, multicenter, randomized, blinded outcome assessment, controlled, add-on therapy phase II study) for the treatment of complex perianal fistulas in subjects with Crohn's disease. EAP-STOMP2 is an expanded access protocol for patients who had adipose tissue collected per the STOMP-II protocol, but who were subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew from the study. Patients who withdrew from STOMP-II for other reasons will not be considered for EAP-STOMP2. This EAP will only be considered at Clinical Investigative Sites who enrolled subjects in STOMP-II.
Inclusion Criteria
In order to be eligible to participate in this EAP, an individual must meet all of the following criteria:
1. Provision of signed and dated ICF.
2. Adipose tissue previously collected per the STOMP-II protocol, but were
subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew.
3. Diagnosed with Crohn’s disease and a target perianal fistula with one internal
opening and at least one external opening.
Exclusion Criteria
An individual who meets one or more of the following criteria will be excluded from participation in this EAP:
1. Suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety.
2. Pregnant, trying to become pregnant, or are breast feeding. Women of childbearing potential (WCBP) and males who have sexual partners that are WCBP must agree to use an adequate method of contraception while participating in this EAP.
3. Known allergies or hypersensitivity to aminoglycosides.
4. History of clinically significant fat-directed autoimmunity.
5. Active, unresolved infection requiring parenteral antibiotics.
6. Unresolved abscess at time of treatment (if screening Pelvic MRI identifies an
abscess, it must be resolved before treatment).
7. Target fistula with any of the following characteristics (note that presence of a second fistula tract that is distinctly separate from the target fistula, or a target fistula with a single internal opening and multiple external openings is not exclusionary):
a. Target fistula has a branching blind ending sinus tract (no external opening) that investigator assesses to be at elevated risk of abscess formation if treated with AVB-114.
b. Target fistula is a genito-urinary fistula, including rectovaginal (i.e., fistulae that
transverse the vaginal canal).
c. Any anatomical limitation to successfully securing the fistula plug disk.
At this time, Avobis Bio is offering an Expanded Access Program on a limited basis pursuant to Avobis’ Expanded Access Protocol. To ensure the safety of patients, we have developed criteria to evaluate applicable Expanded Access Program requests. Any such requests must be in accordance with laws and regulations and our internal policies and procedures. Further, we cannot guarantee access to any investigational drug by any individual patient. FDA guidelines note that Expanded Access may be appropriate when the below criteria are met:
1. Patient has a serious disease or condition, or whose life is immediately threatened.
2. There is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.
3. Enrollment in a clinical trial is not possible.
4. Probable patient benefit justifies the probable risks of treatment with investigational drugs.
5. There is sufficient evidence of safety and effectiveness to support the use of the investigational drug.
6. Providing the investigational medical product will not affect the investigational trials.
7. The Expanded Access request is made by a physician who is qualified and licensed in accordance with State law and who is knowledgeable in the treatment of the disease or condition.
A treating physician must initiate an Expanded Access request. If you are a patient or caregiver, please reach out to your doctor to assist you in this process. Physicians should send Expanded Access requests to expandedaccess@avobisbio.com. The physician requesting Expanded Access must provide specific information supporting the request, including:
1. A copy of the requesting physician’s curriculum vitae (CV).
2. A copy of the physician’s current medical license, which must be in good standing in the state where the therapy will be administered. By submission of a medical license, the requesting physician attests they are not under any investigation or threatened loss of privileges to practice.
3. Relevant patient history, excluding any individually identifiable health information or protected health information (PHI).
4. Scientific rationale supporting the potential benefits of the investigational product based on available clinical and non-clinical data.
5. Statement that there is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the patient’s disease or condition.
6. Statement that the patient has exhausted all approved therapy options, or that the patient is no longer responsive to or able to tolerate such therapies.
We will acknowledge receipt of a physician’s request within five business days.
Medical and scientific professionals at Avobis Bio who are familiar with the available data for the investigational product will evaluate all applicable requests on an individual basis in accordance with the criteria above, pursuant to Avobis Bio’s Expanded Access IND and using the scientific evidence available at the time of the request and other information relevant to patient safety to aid their evaluation.
Posting this policy by Avobis Bio does not guarantee access to any specific investigational drug for any individual patient. We encourage patients to speak with their physicians about the possibility of enrolling in clinical trials in order to gain access to investigational therapies. Additionally, patients can search www.clinicaltrials.gov for information regarding clinical trials. If you have questions about our Expanded Access Program, please contact us at expandedaccess@avobisbio.com