MabVax Therapeutics Granted FDA Authorization for Phase I Clinical Trial with 89Zr-HuMab-5B1

MabVax Therapeutics Holdings, Inc. (OTCQB:MBVX) received notice from the U.S. Food and Drug Administration (FDA) authorizing initiation of a Phase I clinical trial with ⁸⁹Zr-HuMab-5B1 as a new generation PET scan cancer imaging agent in patients with pancreatic cancer.
According to the press release:

The Company filed an Investigational New Drug (IND) application for this trial with the FDA on December 29, 2015.  MabVax previously announced receipt of FDA authorization for a Phase I trial with HuMab-5B1 as a therapeutic treatment for patients with pancreatic cancer, and patient enrollment in both Phase I trials is expected to commence in the first quarter of 2016.

David Hansen, MabVax’s President and Chief Executive Officer commented:

We expect to report interim data from both Phase I trials by the middle of this year, which could have a positive impact on our future commercial and corporate development activities.  We also plan to pursue additional programs with HuMab-5B1 as well as follow-on antibodies under development at MabVax that have the potential for dual-product applications for additional types of cancer.

Click here to view the full press release.