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    DRUG:

    racemetyrosine (SM-88)

    i
    Company:
    Eagle Pharma, Syros
    Drug class:
    Immunostimulant, Free radical stimulant, Oxidative stress enhancer
    Related drugs:
    19d
    Precision Promise: A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P3, N=502, Completed, Pancreatic Cancer Action Network | Active, not recruiting --> Completed | N=825 --> 502 | Trial completion date: Jun 2027 --> Feb 2025 | Trial primary completion date: Jun 2027 --> Feb 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    gemcitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • spartalizumab (PDR001) • sirolimus • pamrevlumab (FG-3019) • racemetyrosine (SM-88) • Ilaris (canakinumab)
    2ms
    HopES: SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Sarcoma Oncology Research Center, LLC | Trial completion date: Mar 2025 --> Mar 2028 | Trial primary completion date: Dec 2024 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    sirolimus • racemetyrosine (SM-88)
    6ms
    Tyme-88-Panct: A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2/3, N=130, Terminated, Tyme, Inc | Completed --> Terminated; Sponsor's decision
    Trial termination • Metastases
    |
    gemcitabine • 5-fluorouracil • capecitabine • sirolimus • racemetyrosine (SM-88)
    1year
    HopES: SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Sarcoma Oncology Research Center, LLC | Trial completion date: Oct 2023 --> Mar 2025 | Trial primary completion date: Jan 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    sirolimus • racemetyrosine (SM-88)
    over1year
    OASIS: Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=11, Terminated, Georgetown University | N=50 --> 11 | Trial completion date: May 2025 --> Feb 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Feb 2023; Lack of efficacy
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    ER positive • HER-2 negative
    |
    sirolimus • racemetyrosine (SM-88)
    2years
    OASIS: Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Georgetown University | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    ER positive • HER-2 negative
    |
    sirolimus • racemetyrosine (SM-88)
    over3years
    OASIS: Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Georgetown University | Not yet recruiting --> Recruiting | Initiation date: Jun 2021 --> Sep 2021
    Clinical • Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    ER positive • HER-2 negative
    |
    sirolimus • racemetyrosine (SM-88)
    over4years
    OASIS: Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Georgetown University
    Clinical • New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative
    |
    racemetyrosine (SM-88)
    almost5years
    [VIRTUAL] In vitro and in vivo anticancer effects of D/L-alpha-metyrosine (SM-88), a novel metabolism-based therapy (AACR-II 2020)
    The importance of amino acid metabolism in cancer has gained greater awareness over the past decade, however potential therapeutic approaches in this area remain limited. SM-88 has been dosed in over 180 cancer patients with encouraging efficacy and safety findings to date. Early data suggest increases in ROS generation and decreases in apoptosis may occur in certain cancer types (PAN02 pancreatic cancer), suggesting a shift away from apoptosis and towards autophagy.
    Preclinical
    |
    CASP3 (Caspase 3)
    |
    racemetyrosine (SM-88)
    over6years
    Phase II trial of SM-88 in patients with metastatic pancreatic cancer: Preliminary results of the first stage. (ASCO-GI 2019)
    SM-88 has demonstrated unconfirmed monotherapy efficacy signals with no meaningful toxicity in a preliminary assessment of this ongoing trial. With additional follow up a dose will be selected for expansion
    Clinical • P2 data
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    racemetyrosine (SM-88)
    over6years
    Phase II trial of SM-88 in patients with metastatic pancreatic cancer: Preliminary results of the first stage. (ASCO-GI 2019)
    SM-88 has demonstrated unconfirmed monotherapy efficacy signals with no meaningful toxicity in a preliminary assessment of this ongoing trial. With additional follow up a dose will be selected for expansion
    Clinical • P2 data
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    racemetyrosine (SM-88)