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AnorMED Receives FDA Response on AMD3100, Initiates Phase III Trials

Strategic Insights

— 1 min read

AnorMED, a biopharmaceutical company, has received a response from the U.S. Food and Drug Administration (FDA) regarding its Special Protocol Assessment (SPA) for two pivotal phase III clinical trials of AMD3100, a potential new stem cell mobilizing agent for stem cell transplantation in cancer patients. The FDA's response is consistent with prior discussions and aligns with expectations for AnorMED's phase III program. The company has begun the phase III trials for AMD3100, with plans to initiate the trials immediately and complete patient enrollment and 3-month follow-up in 2006.

Key Takeaways:

  • AnorMED has received FDA response on SPA for phase III clinical trials of AMD3100, a potential new stem cell mobilizing agent for stem cell transplantation in cancer patients.
  • The phase III trials will enroll 600 cancer patients undergoing autologous stem cell transplantation procedure, with 300 patients in each of two separate trials for non-Hodgkin lymphoma (NHL) and multiple myeloma (MM).
  • The studies are randomized, double-blind, placebo-controlled comparative trials of AMD3100 plus G-CSF versus placebo plus G-CSF.
  • The primary endpoints for the NHL and MM studies are a stem cell collection target of ≥5 million CD34+ cells/kg of patient body weight in 4 or less days of apheresis, and ≥6 million CD34+ cells/kg patient body weight in 2 or less days of apheresis, respectively.
  • AMD3100 has shown a good safety profile in clinical data from over 250 subjects, and has been shown to mobilize stem cells, increasing the number of stem cells in the bloodstream available for collection.
  • AnorMED's phase II clinical data shows that AMD3100 increases the number of stem cells available for transplantation compared to standard stem cell mobilization regimens using G-CSF alone.

Statistics:

  • 600 cancer patients will be enrolled in the phase III program.
  • 300 patients will be enrolled in each of two separate trials for non-Hodgkin lymphoma (NHL) and multiple myeloma (MM).
  • Approximately 45,000 stem cell transplantations are performed yearly worldwide.
  • New clinical data from ongoing phase II studies was presented at the American Society of Hematology conference held on December 4-7, 2004.

Sources:

  • AnorMED press release, date not specified.
  • Health & Medicine Week, "AnorMED Receives FDA Response on AMD3100, Initiates Phase III Trials", 2005.
  • American Society of Hematology conference, "AMD3100: A Novel Stem Cell Mobilizer", December 4-7, 2004.

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