NaPro BioTherapeutics Initiates Patient Treatment in Clinical Studies for Paclitaxel

Strategic Insights -

NaPro BioTherapeutics, a biopharmaceutical company based in Boulder, Colorado, has initiated patient treatment in U.S. clinical studies to explore the use of its patented formulation of paclitaxel in undisclosed cancer indications. The company's Q4D method of administration involves administering between 60 and 135 milligrams per meter of paclitaxel in a 60 to 180 minute infusion on days 1, 5, and 9, repeated every 21 days. This method is a novel approach to delivering paclitaxel, a medication commonly referred to as "taxol."

The clinical studies are expected to provide valuable information for NaPro and its future partner in the filing of a New Drug Application (NDA) for paclitaxel. Sterling K. Ainsworth, Ph.D., NaPro's President and Chief Executive Officer, noted that the company is seeking one or more major pharmaceutical partners to assist in the clinical development and marketing of paclitaxel.

Key Takeaways:

  • NaPro BioTherapeutics has initiated patient treatment in U.S. clinical studies for its patented formulation of paclitaxel in undisclosed cancer indications.
  • The company's Q4D method of administration involves administering between 60 and 135 milligrams per meter of paclitaxel in a 60 to 180 minute infusion on days 1, 5, and 9, repeated every 21 days.
  • The clinical studies are expected to provide valuable information for NaPro and its future partner in the filing of a New Drug Application (NDA) for paclitaxel.
  • NaPro is seeking one or more major pharmaceutical partners to assist in the clinical development and marketing of paclitaxel.
  • Paclitaxel is patented by NaPro and referred to in some scientific and medical literature as "taxol."
  • The company's Q4D method of administration is a novel approach to delivering paclitaxel.

Statistics:

  • 60-135 milligrams per meter of paclitaxel will be administered in a 60 to 180 minute infusion.
  • The infusion will be administered on days 1, 5, and 9, repeated every 21 days.
  • 1998 is the year of announcement of the initiation of clinical studies by NaPro BioTherapeutics.

Sources:

  • NaPro BioTherapeutics, Inc. press release, "NaPro BioTherapeutics Initiates Patient Treatment in U.S. Clinical Studies," July 9, 1998.
  • NaPro BioTherapeutics, Inc. press release, "NaPro BioTherapeutics Announces Termination of Marketing and Development Agreement with IVAX Corporation," March 1998.