Prostate Cancer

Lethal Outcomes

  • Prostate cancer is the second leading cause of cancer-related death, behind lung cancer, and is the most common noncutaneous cancer in American men
  • In 2014, the ACS estimates that 233,000 new cases of prostate cancer will be diagnosed in the US and of these 29,480 American men will die of prostate cancer.
  • Currently, men with localized prostate cancer have limited safe options beyond prostatectomy. Most alternative therapies cause significant side effects and damage to the prostate leading to a high rate of impotence, incontinence and physical damage to the prostate complicating any future surgery and increasing the risk of metastases. These men are often told to wait and get no treatment (“Watchful Waiting”) as current therapies cause more complications and side effects than any benefit.
  • MTG-201 represents a novel therapy with minimal side effects that may have significant efficacy in treating localized prostate cancer while preserving prostate function. Given MTG-201 does not cause any physical damage to the prostate.

 

Early Stage Treatments Not Satisfactory

  • Radical prostatectomy and radiation therapy have severe morbidity including incontinence, impotence, and other adverse events
    • Significant adverse events occur in 15% of cases in mean 60+ years, and in up to 75% of cases in men in their 70s and older
  • Watchful waiting and active surveillance strategies delay the selection of definitive therapy, create patient anxiety regarding untreated cancer, and impose a patient burden with frequent doctor visits and tests
  • MTG-201 represents an alternative to treatment for these men as opposed to waiting for therapy, or consenting to a prostatectomy or high intensity radiation treatment.

 

Key REsults from US Trial: Part 1

  • Excellent safety with generally grade 1 events and rare grade 2 events that occur the first night after treatment, but are resolved within 12 hours.
  • Significant efficacy results with MTG-201 compared to Radiation treatment
  • 12-Core Biopsy CR Rate (P0):
  33% (4 of 12 evaluable subjects)
  • MRI complete response (CR*):
  50% (5 of 10 evaluable subjects)
  • Based on individual tumors CR rate:
  60% (9 of 15 evaluable tumors)
  • All subjects with one exception in the lowest dose group experienced significant tumor volume (MRI) and cancer density (biopsy) reduction after 4 cycles of therapy.
  • No subjects discontinued therapy and tolerability of the treatment was generally considered positive

*CR defined as >99% reduction in tumor volume