This prospective, open-label, pilot Phase II trial evaluates the efficacy and safety of SM-88 in two cohorts of patients: 1) as maintenance therapy following standard primary or palliative treatments for Ewing's sarcoma patients with high risk of relapse or disease progression and 2) as salvage therapy for patients with clinically advanced sarcomas. TYME/JAF HopES Sarcoma Trial: The HopES Phase II trial evaluating the potential benefits of SM-88 for patients with high-risk sarcomas. The following illustration depict how TYME's CMBT compounds like SM-88 kill cancer cells: Clinical results thus far from trials of SM-88 in multiple advanced cancers, including pancreatic, prostate, sarcomas, breast, and other cancers have demonstrated the significant potential of the company's CMBT pipeline The company's lead candidates, SM-88 (racemetyrosine) and TYME-18, are first-in-class CMBT compounds (the company's unique Cancer Metabolism-Based Therapies drug discovery platform). More details of the TYME/JAF HopES Sarcoma Trial will be provided in a press release to be issues during ASCO 2021 from June 4 to June 8, 2021. Based on durable response (>6mo), SD and prolonged TTx, SM-88 warrants additional investigation in this setting.This trial now confirms the previously reported clinical utility of oral SM-88 in EWS and other high-risk sarcomas.HopES continues to enroll toward the planned total of 12 subjects to more precisely define its benefit in this ultra-orphan, extremely recalcitrant disease.SM-88 has exceeded pre-specified futility in both cohorts (EWS maintenance and Ss salvage).ECOG performance remained stable for all.There were no serious drug-related AEs.Stable disease was achieved in 75.0% (6/8 with available data).Prespecified futility stopping was exceeded (i.e., >1 of first 5 subjects/cohort) upon achieving clinical benefit in each.Highlights from abstract number e23505 released on May 19, 2021: Title: Phase II Study of SM-88 in Ewing’s and Other Sarcomas (Nasdaq: TYME) announced that its abstract featuring data from the Company’s investigational therapy, SM-88, has been selected for publication at the American Society of Clinical Oncology ( OTC:ASCO) Annual Meeting being held virtually June 4-8, 2021. Analysts have a BUY recommendation on the stock with a $9.5/share price target. The goal of the strategic review was to assess TYME’s current pipeline, explore additional development opportunities, examine drug development process and determine how best to maximize the efficiency of the Company’s capital expenditures. On June 10, 2021, TYME executive management team will provide an updated business plan derived from the conclusions of the Company’s comprehensive strategic review that was conducted over the past several months.TYME may use a portion of the net proceeds to acquire or invest in businesses, products and technologies that are complementary to its own. On February 8, 2021, TYME announced that it closed its previously announced registered direct offering of 40M shares of its common stock at a purchase price of $2.50/share.Proof-of-concept trials to start in 2H2020. When the patent was announced TYME jumped almost 300%. The company's TYME-19 patented COVID-19 therapy is formulated to overcome any mutations of the virus.Clinical results thus far from trials of SM-88 in multiple advanced cancers, including pancreatic, prostate, sarcomas, breast, and other cancers have demonstrated the significant potential of the company's CMBT pipeline.TYME's 2021 ASCO abstract for drug candidate SM-88 in Ewing and other sarcomas reveals stable disease was achieved in 75.0% (6/8 with available data) with no serious drug-related AEs. ![]() ![]() I am a retired (early) petroleum and chemical engineers with several patents in crude oil refining and gas treating. I've lived and or visited over 50 countries in all continents. ![]() I look for undervalued stocks with significant upside in energy, biotech, and technology.
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