Meditech Research Ltd Announces Progress with FDA Regarding Cancer Therapy HyCAMP

Strategic Insights -

Meditech Research Ltd (MTR), a biotechnology company focused on developing new cancer therapies, has made significant progress in its discussions with the U.S. Food and Drug Administration (FDA) regarding its lead product, HyCAMP. After a formal meeting with the FDA, Meditech has confirmed its intention to submit an investigational new drug (IND) application for HyCAMP in the first half of 2006. The meeting with the FDA marked one of the company's key strategic goals for 2005, and the outcome provided crucial validation of Meditech's overall clinical development strategy.

Key Takeaways:

  • Meditech Research Ltd held its first formal meeting with the U.S. Food and Drug Administration (FDA) regarding its intention to submit an IND application for HyCAMP, a lead anti-cancer product.
  • The FDA accepted Meditech's overall clinical development strategy, confirming that the company's current phase 2 clinical study in colorectal cancer can support the initiation of an IND-based pivotal study in the same cancer type.
  • The FDA also agreed that Meditech's pre-clinical package is sufficient to support an IND application.
  • Meditech plans to conduct a small dose escalation study in colorectal cancer to provide data supporting the use of HyCAMP in an alternative dosing schedule.
  • The dose escalation study and current phase 2 study will form the basis for an end of phase 2 meeting with the FDA.
  • Dr. Ian Nisbet, Meditech's chief executive officer, stated that the meeting with the FDA was a key strategic goal for 2005.

Statistics:

  • The FDA accepted Meditech's overall clinical development strategy for HyCAMP.
  • The company plans to conduct a small dose escalation study in colorectal cancer, which will provide data supporting the use of HyCAMP in an alternative dosing schedule.
  • Meditech has confirmed its intention to submit an IND application for HyCAMP in the first half of 2006.
  • The current phase 2 study in colorectal cancer will support the initiation of an IND-based pivotal study in the same cancer type.

Sources:

  • Health & Medicine Week editors, "Meditech Research Ltd Announces Progress with FDA Regarding Cancer Therapy HyCAMP", 2005, via NewsRx.com.