LOS ANGELES, CA, USA I June 7, 2013 I Puma Biotechnology, Inc. (PBYI), a development stage biopharmaceutical company, announced the initiation of its Phase III clinical trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior treatments (third-line disease).
The Phase III trial will be a randomized trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer. The trial is expected to enroll approximately 600 patients who will be randomized (1:1) to receive either PB272 plus Xeloda or Tykerb plus Xeloda. The trial will be conducted at approximately 150 sites in North America, Europe and Asia-Pacific. The co-primary endpoints of the trial are progression free survival and overall survival. The Company plans to use the progression free survival data from the trial, which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration, as the basis for submission of a New Drug Application (NDA) to the FDA for accelerated approval of PB272 for this indication. The Company also plans to use the progression free survival data from this trial to support a Market Authorization Application (MAA) to the European Medicines Agency for conditional approval for PB272 in the same indication.
Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “Commencing the Phase III trial of PB272 in HER2-positive metastatic breast cancer represents an important milestone in the global development of PB272 and for Puma as a company. We look forward to aggressively enrolling this trial and to pursuing additional registration opportunities for PB272 in HER2-positive breast cancer and in tumors with a mutation in the HER2 kinase, including non-small cell lung cancer, breast cancer and the other solid tumors that we will be studying in our upcoming basket trial.”
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (neratinib), an oral potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2 positive metastatic breast cancer and non-small cell lung cancer.
SOURCE: Puma Biotechnology
Post Views: 207
LOS ANGELES, CA, USA I June 7, 2013 I Puma Biotechnology, Inc. (PBYI), a development stage biopharmaceutical company, announced the initiation of its Phase III clinical trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior treatments (third-line disease).
The Phase III trial will be a randomized trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer. The trial is expected to enroll approximately 600 patients who will be randomized (1:1) to receive either PB272 plus Xeloda or Tykerb plus Xeloda. The trial will be conducted at approximately 150 sites in North America, Europe and Asia-Pacific. The co-primary endpoints of the trial are progression free survival and overall survival. The Company plans to use the progression free survival data from the trial, which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration, as the basis for submission of a New Drug Application (NDA) to the FDA for accelerated approval of PB272 for this indication. The Company also plans to use the progression free survival data from this trial to support a Market Authorization Application (MAA) to the European Medicines Agency for conditional approval for PB272 in the same indication.
Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “Commencing the Phase III trial of PB272 in HER2-positive metastatic breast cancer represents an important milestone in the global development of PB272 and for Puma as a company. We look forward to aggressively enrolling this trial and to pursuing additional registration opportunities for PB272 in HER2-positive breast cancer and in tumors with a mutation in the HER2 kinase, including non-small cell lung cancer, breast cancer and the other solid tumors that we will be studying in our upcoming basket trial.”
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (neratinib), an oral potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2 positive metastatic breast cancer and non-small cell lung cancer.
SOURCE: Puma Biotechnology
Post Views: 207
