Compassionate Use Policy (Expanded Access)
At Spinogenix, our mission is to develop innovative treatments for serious and life-threatening conditions like Amyotrophic Lateral Sclerosis (ALS) and Alzheimer’s disease. We understand that patients who do not qualify for clinical trials may seek access to investigational therapies. In certain cases, we may provide access to our investigational products outside of clinical trials through compassionate use, also known as Expanded Access.

Eligibility:

• U.S. Only
• The patient has a serious or life-threatening condition, such as ALS or Alzheimer’s disease, for which no satisfactory treatment options are available.
• The patient is not eligible to participate in a clinical trial for the investigational therapy, either due to geographic limitations or because the trial is no longer enrolling.
• The use of the investigational drug in the requested manner will not interfere with ongoing clinical trials or the overall drug development process.
  
  
  

Request Process: Compassionate use requests can only be submitted by a licensed physician on behalf of a patient. To submit a request, the physician should provide relevant medical history and justification for the need for access to the investigational therapy.

Contact: For more information or to submit a request, please contact us at
info@spinogenix.com. We will respond to all requests as quickly as possible.

Additional Information: Please note that compassionate use may be limited by the availability of the investigational product and ongoing clinical trials. More information about Spinogenix’s clinical trials can be found at clinicaltrials.gov.

SPINOGENIX IS COMMITTED TO DISCOVERING AND PROVIDING THE WORLD WITH NOVEL THERAPIES AND TREATMENTS, INCLUDING OUR SPG302 AND SPG601 CANDIDATES, FOR ADDRESSING SOME OF THE MOST DEBILITATING DISEASES. ALL OF OUR INVESTIGATIONAL DRUGS ARE STILL IN CLINICAL TRIALS AND ARE NOT APPROVED FOR ANY USE OR UNDER ANY CIRCUMSTANCE OUTSIDE OF OUR CLINICAL TRIALS. SINCE SPINOGENIX IS THE SOLE MANUFACTURER OF THESE THERAPEUTICS AND WE HAVE NOT LICENSED OR AUTHORIZED ANY THIRD PARTY TO MANUFACTURE THEM, IF YOU ACQUIRE SPG302 OR SPG601 FROM ANYONE OTHER THAN SPINOGENIX, IT IS MANUFACTURED BY A COUNTERFEITER. AS SUCH WE CANNOT, AND DO NOT, GUARANTEE ITS EFFICACY OR SAFETY. SPINOGENIX STRONGLY ADVISES AGAINST PURCHASING AND USING ANY SUCH PRODUCTS AS THEY MAY POSE SIGNIFICANT HEALTH RISKS (INCLUDING UNINTENDED AND/OR UNKNOWN LIFE-THREATENING SIDE EFFECTS). SPINOGENIX STRONGLY URGES YOU TO SEEK PROFESSIONAL MEDICAL ADVICE AND GUIDANCE AS TO LEGAL, SAFE AND APPROVED TREATMENTS FOR YOUR DISEASE.