SU5416 Angiogenesis Inhibitor Shows Promise in Phase I Clinical Trial

Strategic Insights -

Researchers have reported that the angiogenesis inhibitor SU5416 appears to be well-tolerated with minimal side effects in patients with advanced cancers. The Phase I clinical trial, conducted at the University of California, Los Angeles (UCLA), involved 60 patients with advanced malignancies, including 11 patients with colorectal and 10 with lung cancer. The study showed that SU5416 has potential as chronic therapy, with four patients having been on the study for over six months, including one patient who has been taking the drug for nearly a year.

Key Takeaways:

  • SU5416, an angiogenesis inhibitor, was found to be well-tolerated with minimal side effects in a Phase I clinical trial involving 60 patients with advanced cancers.
  • The trial, conducted at UCLA, included patients with colorectal, lung, renal cell, and AIDS-related Kaposi's sarcoma (KS) cancers.
  • Patients on the study for over six months, including one for nearly a year, suggest that SU5416 may have potential as chronic therapy.
  • Most side effects observed were mild, primarily Grade 1 and 2, including pain at injection site, pharyngitis, phlebitis, and headache.
  • SU5416 may have clinical activity in cancer patients, including those with colorectal, lung, and renal cell cancers.
  • The company is preparing to initiate Phase II trials with SU5416 in selected indications, including colorectal and lung cancers, by the first quarter of 1999.

Statistics:

  • 60 patients with advanced malignancies were treated in the Phase I dose-escalation study at UCLA.
  • 11 patients with colorectal cancer and 10 with lung cancer were included in the study.
  • SU5416 was administered twice weekly in an intravenous formulation, with escalating doses up to 145 mg/m^2.
  • Four patients have been on study for over six months, including one patient who has been taking the drug for nearly a year.
  • 10 patients have been on the study for over three months.

Sources:

  • The data were presented at the Biologic Principles for the Therapy of Human Colon Cancer Conference, held in San Diego, California, November 7, 1998.
  • The University of Texas M.D. Anderson Cancer Center of Houston, Texas, hosted the conference.
  • Lee Rosen, MD, UCLA's Jonsson Cancer Center, made statements about the potential clinical benefit of SU5416.