PANCREATIC CANCER FDA CLINICAL TRIAL – INITIAL RESULTS WITH hPAM4®

The information contained here on the results of Immunomedics’ hPAM4® compound when combined with Gemcitabine® for the treatment of pancreatic cancer was presented to the public at the company’s “R&D Day” held on September 17th at the Waldorf Astoria Hotel in New York City.

At the time of this presentation, two patients who had been diagnosed and whose disease had progressed to Stage IV metastasized tumors, had been treated in the Phase I clinical trial.* Both patients had no prior chemotherapy of any kind, which was a requirement for entry into this trial. One of them, Calvin, was diagnosed on October 2nd of 2007 and had his first treatment (of 4 infusions over the course of a month) in February of 2008; a second treatment was administered in April; and a third treatment was given during the latter part of August. The second patient is Martha, who was diagnosed on March 17, 2008 and had her first treatment in May, and a second sometime before the end of August. The links to the right of this text will enable viewing of the presentation of their responses to the treatment, which according to Dr. Kenneth Pennington, Medical Oncologist at The Goshen Center for Cancer Care in Goshen, Indiana were “dramatic.”

This 20 minute presentation is in three parts:

  • The first is an audio narrative by Dr. Matthew Leoni, Senior Manager of Clinical Research at Immunomedics, and is accompanied by PET Scans of the two patients, which show both a significant reduction in the size of their metastasized tumors and an impairment of the tumors’ metabolic activity.
  • The second part is a video of Dr. Pennington where he discusses the history of treatments for pancreatic cancer that preceded this newly developed regimen of combining IMMU’s hPAM4 with Gemcitabine and then summarizes the results with the two patients, Calvin and Martha.
  • The third portion contains video of Calvin and then Martha, both of whom discuss their treatments’ effect upon them.

This is a powerful and compelling presentation of what may be a breakthrough in the treatment and subsequent management of this devastating disease. In February of 2009, the FDA granted hPAM4 “Fast Track” status.
http://finance.yahoo.com/news/Immunomedics-hPAM4-Labeled-pz-14264864.html

* More information on the FDA Phase I trial of these combined compounds can be found at: http://www.clinicaltrials.gov/ct2/show/NCT00603863?term=Immunomedics


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