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First, for a drug to be exported under section 802(b)(2) of the FD&C Act, FDA must make a determination concerning the country’s approval framework for drugs that involves several...
23 sie 2019 · Five Ampligen clinical trials that are open for enrollment evaluating the safety and ability of Ampligen to increase the effectiveness of cancer immunotherapy, creating synergy for checkpoint blockade drugs by reprogramming the tumor microenvironment
24 cze 2019 · The U.S. Food and Drug Administration (FDA) has authorized the initiation of a Phase 2 clinical trial testing Hemispherx Biopharma‘s Ampligen (rintatolimod), in combination with aspirin or aspirin plus Intron A (interferon-alpha 2b), as a treatment for prostate cancer patients before surgery.
We ultimately determined, and have described in the guidance, that a “weight of evidence” approach can provide an adequate assessment of carcinogenic risk in certain cases without using data from...
AIM ImmunoTech Inc., formerly known as Hemispherx Biopharma Inc., is a biopharmaceutical company based in Ocala, Florida that is focused on the research and development of therapeutics to treat multiple types of cancers, various viruses and immune-deficiency disorders. [2]
Hemispherx estimates that completing the process of bringing its bioreactor production process online with FDA approval could require roughly 15 to 16 months and approximately $15 million in funding.
Hemispherx Biopharma has started dosing patients in a Phase I clinical trial evaluating its Ampligen (rintatolimod) plus Merck’s Keytruda (pembrolizumab) for the treatment of triple-negative breast cancer. Ampligen is a dsRNA TLR3 agonist, while Keytruda is an anti-PD-1 check-point blocker.
