Some things never get old. Like watching the sunset over the Grand Canyon. Listening to a baby laugh. Watching the San Francisco Giants win the baseball World Series. Now you can add to that list learning that one of the clinical trials we are funding has just treated their first patient.
The latest to join that growing list is Caladrius Biosciences (previously called NeoStem). We recently awarded them $17.7 million to carry out a Phase 3 metastatic melanoma clinical trial targeting cancer stem cells. These cells are believed to be able to survive chemotherapy and other cancer-targeting treatments, and can cause a relapse by enabling tumors to grow and spread.
Caladrius’ approach is a personalized one. They use the patient’s own tumor cells to create a therapeutic vaccine called (for now at least) CLBS20. It’s designed to engage the patient’s own immune system and destroy the cancer.
This first patient was treated at Thomas Jefferson University Hospital in Philadelphia. Altogether Caladrius hopes to enroll some 250 patients at more than 40 sites worldwide, for the trial. Seven of those sites are here in California; that’s the portion of the project we are funding.
Because this is a randomized, double blind study it’s not known if the patient was treated with CLBS20 or a placebo. But in a news release Dr. David J. Mazzo, CEO of Caladrius Biosciences, says it’s a big first step:
“The dosing of the first patient in this Phase 3 trial is an important milestone for our Company and the timing underscores our focus on this program and our commitment to impeccable trial execution. We are delighted by the enthusiasm and productivity of the team at Jefferson University and other trial sites around the country and look forward to translating that into optimized patient enrollment and a rapid completion of the Phase 3 trial.”
In the earlier Phase 2 trial, 72 percent of those who got the therapy were still alive after two years, compared to 31 percent of people who got a placebo therapy. There was another bonus for patients; the treatment was well-tolerated with few side effects, the most common being irritation and a reaction at the site of the injection.
There’s a big need for this approach. In 2014 there were approximately 20,000 new cases of metastatic melanoma and nearly 10,000 deaths. It usually causes death within one to two years and only 10 to 15 percent of patients survive five years.
Here’s where to go if you would like more information on the Intus Study or you can also visit the NIH clinical trials site.
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