Background: Patients with metastatic pancreatic cancer who have progressed on two prior lines of therapy have a poor prognosis with an overall survival in the range of 2-2.5 months.
There is currently no standard of care for these patients that has demonstrated improved outcomes.
①SM-88 (D,L-alpha-metyrosine; racemetyrosine [USAN]) is a proprietary dysfunctional tyrosine derivative and is the backbone of SM-88
②SM-88 is used with MPS (Methoxsalen 10mg, Phenytoin 50mg and Sirolimus 0.5mg; all administered daily).
③SM-88 monotherapy was relatively well tolerated, with improvement in survival in select patients with heavily pretreated PDAC who achieved stable disease on therapy (HR 0.08, p = 0.02).
④ Circulating tumor cells (CTC’s) were prognostic and decreased on therapy with SM-88 potentially identifying a subgroup of PDAC that may be most likely to benefit from therapy (Noel et al. Annal Oncol V30, Suppl 4, 2019).
Preliminary radiomic analysis of the largest metastases at baseline suggested the same benefits including a correlation with baseline CTCs, changes in CTCs on therapy and OS (Ocean et al, Annal Oncol, V30, Suppl 5, 2019).
Here, we describe a randomized, open-label, phase 2/3 trial evaluating the efficacy of SM-88 + MPS vs physician’s choice treatment as third line therapy for patients with metastatic PDAC......
Pretty heady stuff here Handsome. I can wait a couple of months. Figuring our minor losses coming from over reaction to last EDGAR filing (Tuesday's Form D) where following insiders providing more funding:
Hoffman, Steve Executive & Director Galani, Barbara Executive Officer DeGolyer, Donald Director Michels, Douglas Director Sokol, Gerald Director Sturman, Paul Director Thompson, Tommy Director Tyson, Timothy Director Taylor, Ben Executive Officer Del Priore, Giuseppe Executive Officer Eckard, Jonathan Executive Officer Korfin, Michele Executive Officer Carberry, David Director
AI
