Valley Fever Solutions

October 28, 2020 Review article

Larwood DJ. Nikkomycin Z-Ready to Meet the Promise?
J Fungi (Basel). 2020 Oct 30;6(4):261. doi: 10.3390/jof6040261. PMID: 33143248; PMCID: PMC7712250.
Abstract  –  Article

News - January 13, 2020
David Larwood Interview at Biotech Showcase

    Our CEO explains our drive and inspiration.
   
  "Cure" is a big word in human therapy, which we seek but won't claim with finality as "cure" is notoriously difficult to prove. We anticipate approaching that in at least many humans, and we are showing good progress. NikZ is fungicidal in several pre-clinical studies, eliminating detectable Valley Fever.
  We recently extended pre-clinical testing that showed complete elimination of severe disseminated Valley Fever with a 5 day therapy in animals. Human disease has some similarities but many differences from disease in small animals. The course and severity of Valley Fever in humans has strong similarities to impact on dogs. In an important study, treating dogs with natural Valley Fever with NikZ showed 33% cleared or nearly cleared symptoms in two months, half the usual starting duration in dogs and humans. We plan to study this more closely when we have drug supply.
   We plan to test NikZ in humans, where a quicker resolution of symptoms would be transformational. About half of humans with early Valley Fever get through the disease, with challenges, in about 12 weeks. Of the other half, a significant number endure the disease longer. Some 2,000 a year develop more serious Valley Fever that can last months to years, even with drug therapy. Of these, about 1,000 cannot use current drugs, so they have no therapy options. Among the 2,000, a significant number get Valley Fever in the brain. This is 100% fatal without therapy. Most of these patients can use existing therapy, but must maintain this for life. typically requires months to resolve in a fairly healthy patient, and months to years of drug therapy for about 25,000 new patients a year.
We hope to reduce the current 150 annual deaths.
  We have a plan to reach approvable data within 18 months, and hope to be commercial about a year later. We look to expand testing in other diseases known to show sensitivity to NikZ.
  Historical challenges with drug supply capability are mostly resolved. We can supply trial scale now, and expect to be able to supply market requirements to any level within about 9 months, in good alignment with human clinical trial plans.

David Larwood Interview at Biotech Showcase 2019

    Our CEO explains our driving inspiration. We look forward to our planned orphan-scale Phase 2 trials.     Interview

October 2, 2019 Phoenix, February 7, 2019 San Francisco at Cavendish Forum

    Our CEO explains progress and the passion behind our projects   2017, San Diego (YouTube)

Bringing Drug Supply On Line

    Starting March 2018, VFS engaged a manufacturer to make large pilot scale clinical trial material. We are preparing to undertake large scale manufacture.

FDA Meeting

    VFS met with the FDA in January 2019 to review VFS progress, and plans for Phase 2 trials.

News - VFS Graduates CLSI FAST (Fellows All Star Team) Advisory Program

  We were excited to participate this exciting program. Our final showcase presentation June 12, 2018 was well received.
CLSI: Six life science startups, vetted and selected by a distinguished review panel, were selected for CLSI’s Spring 2018 Fellows All-Star Team (FAST) Advisory Program.
    Each company founder was paired with a team of 10 to 12 advisors who met for 12 hours of advisory sessions. The advisors for our team had major roles in commercializing more than 20 drugs, which sharpened our perspective on regulatory issues and a more detailed TPP. These meetings culminated in a final FAST Showcase on June 12 to a broad audience of industry professionals and investors.

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