Humanigen is Accepting Compassionate Use Inquiries for LENZ
Compassionate use is intended to provide access to investigational medicines for patients with serious or life-threatening conditions who have limited available treatment options and are unable to participate in ongoing clinical trials.
Key Criteria for Consideration:
Suspected or laboratory confirmed SARS-CoV-2 (COVID-19) pneumonia in hospitalized patients aged ≥18 years
SpO2 ≤ 94% on room air or requiring low flow/high flow supplemental oxygen or non-invasive positive pressure ventilation (NPPV)
Baseline CRP<150 mg/litre
Subject is not pregnant and for females of child-bearing age that are not pregnant, will take adequate contraception
Subject is not eligible to participate in any ongoing trials with LENZ and other therapeutic modalities have proven ineffective, are inappropriate or are unavailable at time of request
Requests for compassionate use must be initiated by a treating physician, so if you are a patient or caregiver, please ask your physician for support in this process.
Humanigen will acknowledge receipt of the individual compassionate use request by either phone or email in <24 hours.
All individual patient compassionate use requests submitted for LENZ must be for the treatment of hospitalized COVID-19 patients and will be evaluated carefully, fairly and on a case-by-case manner.
The following information should be included in the request:
Date of request
Requesting physician’s name, contact information (phone and email), address, and professional designation (e.g. MD)
Shipping address for LENZ vials
Confirmation that the patient is not eligible or able to participate in any ongoing clinical trials with LENZ, and therapeutic alternatives have proven ineffective or are unavailable at the time of the request
Administration of compassionate use treatment must be in accordance with applicable laws, in accordance with FDA guidelines and requirements
Physicians should send compassionate use and Clinigen LenzMAP requests for LENZ to