stands upon the seminal work of the late Prof. Jurg Tschopp and the discovery of the inflammasome signaling platform. They have extended this work and related inflammasome signaling to endoplasmic reticulum (ER) stress, the unfolded protein response (UPR), and the genesis and progression of chronic diseases.

They have also shown that Naclynamide effectively resolves the excess collagen production in cells from Scleroderma patients and reverts these cells from their diseased phenotype (myofibrolasts) to the normal phenotype (fibroblasts). They expect to file their IND within the next 12 months for the use of Naclynamide™ in the treatment of diffuse Scleroderma. They plan to follow with the use of Naclynamide™ in related diseases.

Standing upon their discoveries, they have developed a new drug candidate, Naclynamide, that they have already shown to be safe and effective in two different cancers in dogs that were resistant to conventional chemotherapy. Canine cancer is widely regarded to be the same disease as human cancer. They believe that this is related to a shared microbiome that has developed from co-evolution of dogs and man. Moreover, they believe that chronic/persistent/latent infection accounts for several types of cancer as well as the prevalence/incidence of many cancers. They are planning to follow lead indication with an indication for the treatment of selected cancers.

They have established the proof of principle for Naclynamide™ use as a pre-exposure and post-exposure drug candidate in animal models of a lethal Gram negative bacterial infection and a drug resistant MRSA infection. Their published research has clearly established the enhanced innate immune response and recruitment and activation of immune cells and a potent opsono-phagocytic and cytotoxic T-lymphocyte response as the mode of action for Naclynamide™ (Adamson, et al. Cancer Biology & Therapy 2014, 15(4), 1-11). Their molecular biology studies have shown the intracellular protein target of Naclynamide™ to be XBP1 and they have elucidated the down-stream signaling pathway through NLRP3 inflammasome activation and innate and adaptive immune gene up-regulation.

Their collaborator, Brian Balin, as well as investigators from other institutions, have been promoting the idea that chronic/persistent/latent infection may lead to Alzheimer’s Disease. They have shown that Naclynamide™ effectively eliminates obligate intracellular pathogens and may be effective as a treatment.

Because Naclynamide™ has potent anti-fibrotic activity, they are presently evaluating its efficacy in idiopathic pulmonary fibrosis. Preliminary results indicate a similar efficacy in this disease. Therefore, they intend to seek approval for use of Naclynamide™ in this disease as well.

Their advisory board is led by Dr. Phil Gerbino. Dr. Gerbino is a Fellow of the College of Physicians of Philadelphia; the American Pharmacists Association (APhA), Academy of Pharmacy Practice and Management; and the American Society of Consultant Pharmacists (ASCP). He received the 2010 Frank Baldino Jr., CEO of the Year Award from Pennsylvania Bio was recognized in PharmaVoice, 2005, Top 100 as a “Change Agent”. He is the recipient of national leadership awards including those from Merck, Hoechst-Roussel, Parke-Davis, Upjohn, Procter & Gamble and others.