After winning the "King of Cancer" orphan drug, it entered the high-risk sarcoma SM-88 into a pan-cancer species of anti-cancer star

Author . . On August 3, 2020, the FDA awarded Tyme Technologies SM-88 orphan drug certification for the treatment of patients with advanced pancreatic cancer.
among all cancer types, advanced pancreatic cancer has the lowest survival rate, with a five-year survival rate of only 9% and an average survival of only 2 months in end-stage patients, so it is known as the "King of Cancer".
FDA awarded SM-88 the title of "orphan drug" for third-line treatment of pancreatic cancer patients, breaking the situation that pancreatic cancer patients are not available on the third line.
recently, SM-88 successfully entered high-risk sarcoma, is expected to become a pan-cancer species anti-cancer star.
SM-88SM-88 is an original combination therapy developed by Tyme.
it is neither targeted nor immunotherapy, but a new combination therapy that kills cancer cells by interrupting their metabolic processes.
SM-88 consists of four components, the core of which is a dysfunctional tyrosine derivative that serves as the wrong building blocks for protein synthesis, including mucus; Ingestion of dysfunctional tyrosine derivatives), Phenytoin (increases the type of active lipid in the tumor microencase to enhance the redox potential of cancer cells), and Methoxsalen (increases the type of melanin and reactive oxygen and actes as a catalyst for oxidation reactions).
clinical data show that SM-88 has shown good remission in 15 malignancies, including pancreas, lung, breast and prostate cancers, as well as sarcoma.
SM-88's successful foray into sarcoma Tyme Technologies announced that the interim evaluation of the HopES Sarcoma Phase 2 clinical trial is positive and will continue to evaluate the efficacy of SM-88 in treating patients with Juve sarcoma and other high-risk sarcoma.
HopeES sarcoma trial is a Phase 2 open label study that is evaluating the safety and effectiveness of SM-88 combined methicillin, phenytoin, and siromos.
The study is expected to recruit 24 patients with a total of 2 cohorts, and queue 1 will assess the effectiveness of SM-88 as a single-drug maintenance therapy for patients with high-risk Juve sarcoma after standard treatment or palliative care, and Queue 2 will evaluate the effectiveness of SM-88 as a single-drug rescue treatment for patients with advanced sarcoma.
from January 2020.
the main endpoints of the trial included total remission rate, disease stabilization rate and non-progression survival.
secondary endpoints include mitigation duration, total lifetime, clinical benefit rate using RECIST v1.1 standard, and the rate of adverse reactions (AE) during treatment.
II. Phase 88-Panc Pancreatic Cancer Trial - SM-88 is still valid for end-stage patients After a large number of studies have shown that after diagnosis of pancreatic cancer, 80% of patients will die within one year, and after second-line treatment, the total survival of the middle is 4 to 6 months.
88-Panc Pancreatic Cancer Trial (NCT03512756) has tested two dose levels of SM-88 and confirmed an increase in survival rates in patients with advanced pancreatic cancer.
the study, patients were randomly assigned to receive 460 mg SM-88 (once a day) or 920 mg SM-88 (once a day).
all patients received 10 mg of methicillin (once a day), 50 mg of phenytoin (once a day), and 0.5 mg of siromos (once a day).
of the 19 assessable patients with end-stage pancreatic cancer, 67.8 percent survived a mid-stage follow-up of 4.3 months.
more than doubled the expected total survival time (2.0 months) for patients with third-line pancreatic cancer based on historical studies.
It's worth noting that the 38 patients in the first study were all terminal metastatic pancreatic cancer patients who had been overtreated and had very serious progressions, with an expected survival of only 2 months, and usually doctors would recommend that they go into hospice care.
results showed that 47.1% of patients had clinical benefits, including stable conditions (n=7) and partial remission (n=1).
that, in general, the response rate of second-line trials of pancreatic cancer is 10 percent, and third-line treatment is almost ineffective.
in 88-Panc, SM-88 decreased after 2 months of treatment in 5 patients receiving at least second-line treatment (n - 17).
of these patients, one received second-line treatment and the other received fourth-line or more treatment, reducing lesions by more than 30%.
, CA19-9 or cancer embryo antigens were reduced in 9 patients.
in terms of safety, SM-88 is well-to-do, with only 2 cases (6.5%) of severe adverse events (SAEs) considered to be at least potentially associated with SM-88.
these SAEs occurred in the same patient, who continued to receive SM-88 treatment.
this trial, the FDA has awarded SM-88 the title of orphan drug for the treatment of advanced pancreatic cancer.
Tyme Technologies is a clinically emerging biotechnology company focused on developing metabolic-based cancer therapies for the treatment of a wide range of tumors.
unlike targeted therapies that try to regulate specific mutations in cancer, the company's treatments are designed to exploit the inherent metabolic weaknesses of cancer cells, impair their defenses, and cause cell death through oxidative stress.
SM-88 is a leading drug for Tyme Technologies, and we look forward to good results in more cancers.
source: 1.
TYME provides business update and reports four quarter and fiscal year 2019 financial and operating results. News release. TYME Technologies. May 29, 2019. Accessed August 3, 2020.Noel MS, Wang-Gillam A, Ocean AJ, et al. SM-88 therapy in high-risk poor prognosis pancreatic cancer (PDAC). Ann Oncol. 2019;30 (suppl 4): iv16. doi:10.1093/annonc/mdz155.058.