First Human Study

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FIRST HUMAN STUDY

Our First Human Study began as an IRB-approved protocol initially designed as a six-week safety study of SM-88 monotherapy in 30 end-stage metastatic cancer patients. However, it continued for multiple years given the clinical benefit experienced by a large portion of patients.

The trial a range of cancer types with the largest subsets being breast cancer (n=14), lung cancer (n=5), and pancreatic cancer (n=3). With regards efficacy findings during the trial, ten patients (33%) in the trial achieved a complete response or a partial response, according to RECIST 1.1 evaluation criteria, and a further 17 patients (57%) achieved stable disease. The final median overall survival for the entire trial was 29.8 months, with 5 patients currently alive over 5 years from starting SM-88.

Subsequent analysis of the results has also provided encouraging results in multiple subgroups.  Some include:

  • Median 29 months overall survival in patients achieving stable disease according to RESIST 1.1
  • Patients receiving no subsequent therapy experienced a longer median overall survival (OS) than patients who received subsequent treatments beyond SM-88
  • Patients with two or more prior systemic therapies experienced a median overall survival of 23 months, including two complete and three partial responses after beginning SM-88 therapy
  • Overall survival was comparable for patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Overall Survival Based on Subsequent Treatments Following SM-88

Overall Survival Based on Number of Systemic Therapies Prior to SM-88

Overall Survival by Baseline ECOG Performance Status

COMPASSIONATE USE PROGRAM

In addition to the First Human Study, as of early 2017, 76 Compassionate Use Patients who had failed-or-refused possible available treatments were treated with SM-88 through IRB-reviewed compassionate program. Some of these patients had been treated for over four years, demonstrating complete and partial responses across a multitude of cancer types.

We conducted an analysis in early 2016 on 57 patients from this program and have presented the tumor activity observed in these patients. Overall, the objective tumor response rate (ORR) according to RESIST 1.1 was 47%,

Summary of RECIST Complete and Partial Responses from 57 Compassionate Use Patients

Summary of Antitumor Activity with SM-88 from 57 Compassionate Use Patients

We intend to publish additional data on Compassionate Use Patients through peer-reviewed publications and medical conferences during the course of the next 12 months.