Weekly News Update

How is the human race is fighting back against the chronic conditions that plague us?

Alzheimer’s Disease affects 5.7 million Americans. While a few symptomatic treatments are available, there are no approved disease modifying treatments. This is a debilitating condition that slowly progresses to steal the mental capacities of our loved ones, right before our eyes. As family members, caretakers and friends are mostly helpless as our loved ones slip into the abyss of disease, become only slivers of their former personas with no defense against what is happens or even what is going to happen in the near future. The mind fails in this chronic condition but the body has the capacity to live for years physiologically and this situation creates a paradox laced with anguish as helpless onlookers try to make life better for the victim but have no useful tools. 

Cyclo Therapeutics has signed an agreement with Worldwide Clinical Trials, a Contract Research Organization (CRO), to conduct a clinical trial to evaluate the safety and efficacy in Alzheimer’s Disease. The trial will evaluate Trappsol® Cyclo™ given by intravenous infusion. The Company has previously reported encouraging data on safety and efficacy of the product based on an FDA-approved expanded access program in a single patient with late-onset Alzheimer’s Disease.

Usually in the scientific world, single iteration data sets are never anything to get excited about until there is a successful repetition of the result. In the pharmaceutical industry, excitement really doesn’t kick in until the second phase of clinical trials when you know that your drug is not going to kill anyone and you know that the drug does what you think it does for the patient. In phase II trials, the numbers are ramped up to develop dosing profiles and gather pharmacokinetics in hundreds of patients. That is the normal course of action in drug development. 

But for this drug and this disease, there is excitement with an n=1 with a positive result. Cyclo Therapeutics and Worldwide are designing the trial protocol and expect to schedule a scientific advice meeting with the U.S. FDA in early 2020. Patient enrollment is expected to begin shortly thereafter. The potential this drug brings to Alzheimer’s patients and families is huge. The work Cyclo Therapeutics is doing to advance an innovative approach to treat this devastating disease may lead to improvements in the lives of Alzheimer’s patients and their families. 

This whole article can be found at: https://www.pharmoutsourcing.com/1315-News/557217-Cyclo-Signs-Agreement-with-Worldwide-Clinical-Trials-to-Conduct-Alzheimer-s-Disease-Trial/

Another chronic debilitating human disease is Multiple Sclerosis. MS is a lifelong disease that has a significant impact on the people affected and their caregivers. 

Biogen and Alkermes announced the U.S. Food and Drug Administration (FDA) approved VUMERITY™ (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Once in the body, VUMERITY rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate.

Biogen holds the exclusive, worldwide license to commercialize VUMERITY and intends to make it available in the United States in the near future. 

This whole article can be found at: https://www.americanpharmaceuticalreview.com/1315-News/557203-Biogen-Alkermes-Announce-FDA-Approval-of-VUMERITY-for-MS/

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Dr. Joe Nieusma and the Superior Toxicology & Wellness Team


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