Powerful anti-herpes drug moves forward: hope for ME/CFS/FM patients
by Cort Johnson, June 8, 2015.
The “IT” drug for herpesviruses
Chimerix has been producing the “it” herpesvirus drug under production. Brincidofovir (formerly CM001) is another example of technology moving forward. Brincidofovir is Vistide – a powerful antiviral drug – encased in lipid format. Vistide has propelled some ME/CFS patients to health but is little used because of its complex infusion process, the possibility of severe kidney damage, and the frequency of blood tests needed.
New Package – New Results
Chimerix has a proprietary lipid technology that can be used to enhance absorption in the gut and significantly enhance tissue penetration. This technology involves attaching lipid side-chains to antivirals, such as nucleotides, that are limited by poor gut absorption. These lipid-antiviral conjugates are thought to mimic a phospholipid in the cell membrane and thus use the natural uptake pathways in the small intestine to achieve oral bioavailability and efficient tissue penetration. [From the Chimerix website]
Chimerix’s propriety ‘packaging’ process has the potential to change all that. The packaging advance was innovative enough for Brincidofovir to be considered a ‘new chemical entity’ and be protected by patent laws.
Brincidofovir’s only side-effects appear to involve the gastrointestinal system. Chimerix reports they are ‘easily monitored and rapidly reversible’.
Plus, Chimerix states studies have shown that Brincidofovir is not just a little bit more, or even moderately more, but ‘much more potent’ than the original drug (Vistide) against a wide variety of viruses. A 2012 review named it as one the ‘ten hot topics’ in antiviral research. This drug could initiate a new era in treating herpesvirus or other unrelated infections.
Chimerix and Brincidofovir are no flashes in the pan. The drug, with over twenty-five studies devoted to it in the past five years, has been well studied. It may be able to potentiate the effects of other antivirals such as aciclovir and be useful for patients who have not responded well to antiviral therapy. The Phase II placebo-controlled trial went remarkably well given how toxic Vistide can be. No adverse side-effects were reported and no alterations in renal function or blood chemistry were found.
This year the federal government awarded Chimerix $100 million to continue its work with smallpox and brincidofovir. The drug was given to several Ebola patients during the recent outbreak.
Fast-Tracked Drug
The drug was awarded fast track status by the FDA. Today Chimerix reported that it’s 450 person Phase III trial to combat cytomegalovirus infections in transplant patients filled up faster than expected. The company anticipates they’ll be able to begin reporting on the clinical trial results in early 2016. It appears that one Phase III trial will be enough for the FDA. One source reported the drug could be FDA approved and available in 2016.
Chimerix noted that a antiviral has not been approved for transplant patients – who are highly susceptible to viral infections – in over ten years.
Hope for ME/CFS and FM patients
Dr. Peterson’s April 2013 report that 70% of severely ill ME/CFS patients with herpesvirus infections (HHV6, HCMV) improved significantly on Vistide, with many returning to work, suggests Brincidofovir could be a boon to a subset of ME/CFS patients.
ME/CFS patients who couldn’t tolerate the large doses of antivirals taken sometimes for years or those who didn’t benefit from their first try with antivirals could be helped. People who were helped by antiviral drugs but have not recovered could be helped more. Dr. Peterson has been holding this drug out as hope for his more severely ill patients for some time now.
There’s no telling the cost of the drug should it be approved, but new drugs typically come at a high cost. A more powerful drug that can be given in smaller doses (no infusions required!) might end being less expensive in the long run than the less powerful antivirals that are often taken in large amounts for years.
Brincidofovir is more than just a herpesvirus drug; it’s also being marketed as a broad spectrum antiviral and is currently against two very unherpes-like viruses, adenovirus and smallpox. It’s been granted fast-track status for all three viruses.
