Therapy available via single-patient Expanded Access:
1. Proprietary phosphoethanolamine-based blend (containing 540 mg per capsule of Phosphoethanolamine as Calcium-2-aminoethyl phosphate, Magnesium-2-aminoethyl phosphate & Zinc-2-aminoethyl phosphate) combined with Bactrim (sulfamethoxazole/trimethoprim) or another appropriate antibiotic when resistance is present.
Vidamax Therapeutics LLC is committed to making our investigational cancer treatment available through single-patient Expanded Access (compassionate use) when no satisfactory approved treatment options exist.
Product
Our patent-pending combination consists of a proprietary phosphoethanolamine-based blend (containing 540 mg per capsule of Phosphoethanolamine as Calcium-2-aminoethyl phosphate, Magnesium-2-aminoethyl phosphate & Zinc-2-aminoethyl phosphate, plus Calcium, Magnesium, Zinc and Phosphorus as listed on the Phosphopure label) administered together with Bactrim (sulfamethoxazole/trimethoprim) or another appropriate antibiotic when resistance is present (U.S. Provisional Patent Application No. 64/018,482).
Single-Patient EA Policies and Criteria
We will consider requests for individual patients who meet the following criteria:
• The patient has advanced or terminal cancer with no satisfactory approved treatment options available.
• The treating physician determines that the potential benefit of the treatment outweighs the potential risks.
• The patient is unable to participate in a clinical trial.
• The request is made by a licensed oncologist in the United States.
Request Process
Physicians should submit requests through the FDA’s Project Facilitate program (phone: 240-402-0004 or email: OncProjectFacilitate@fda.hhs.gov).
Requests should include a completed FDA Form 3926, a brief clinical summary, and rationale for use. We will promptly provide a Letter of Authorization upon request.
We aim to acknowledge receipt of a complete request within 5 business days. Decisions are made on a case-by-case basis considering medical, scientific, and logistical factors, including product availability.
Cost
We offer the product at no cost to the patient or treating institution.
Contact
Yanic Vida
CEO
VidaMax Therapeutics LLC
Info@vidamaxtherapeutics.com
+1 (424) 335-6967
853 S Lucerne Blvd #204
Los Angeles, CA 90005
We reserve the right to revise this policy at any time.