Procept Announces Completion of Phase I Safety Trial for Lead Drug Candidate PRO 2000

Strategic Insights -

Procept, Inc. has announced the completion of its Phase I safety trial in the United Kingdom with the Company's lead drug candidate, PRO 2000, for the treatment of human immunodeficiency virus type I (HIV-1). The initial examination of the Phase I data indicates that PRO 2000 was well tolerated in the 36 healthy volunteer, rising dose, placebo-controlled study. PRO 2000 is designed to bind to CD4, the receptor on T cells which the virus uses as its portal of entry into the immune system, thereby preventing the destruction of normal immune function.

The Company's novel approach specifically targets the cellular CD4 protein rather than one of the HIV-1 proteins, making it less likely to lead to drug resistance. "We are pleased that PRO 2000 was well tolerated in our initial safety trial. These results now allow us to evaluate PRO 2000's safety and antiviral activity in HIV positive patients," said Stanley C. Erck, President and CEO of Procept. The Company will use these data in its submission for approval to begin a Phase I/II study of HIV positive patients in the Netherlands.

Key Takeaways:

  • Procept, Inc. has completed its Phase I safety trial with the lead drug candidate PRO 2000 for the treatment of HIV-1.
  • The trial involved 36 healthy volunteers in the UK and demonstrated PRO 2000's well-tolerated nature in a rising dose, placebo-controlled study.
  • PRO 2000 is designed to bind to CD4, the receptor on T cells used by the virus as its portal of entry, thereby preventing immune system destruction.
  • Procept's approach targets the cellular CD4 protein, a non-mutable human protein, making it less likely to lead to drug resistance.
  • The Company will use phase I data to submit for approval to begin a phase I/II study of HIV positive patients in the Netherlands.
  • Procept is researching therapeutics for the treatment of arthritis, diabetes, organ transplant rejections, and AIDS.
  • The Company has a diverse portfolio of small molecule therapeutics for the prevention and treatment of chronic and life-threatening immune system disorders.

Statistics:

  • 36 healthy volunteers participated in the Phase I safety trial.
  • PRO 2000 demonstrated well-tolerated nature in the rising dose, placebo-controlled study.
  • The Phase I data will be used to submit for approval to begin a Phase I/II study of HIV positive patients in the Netherlands.

Sources:

  • "Procept Announces Completion of Phase I Safety Trial with PRO 2000, Lead Candidate for the Treatment of HIV-1." (May 19, 1995)
  • Procept, Inc. press release.