Very good article about immunotherapy and bodes well for PRR.
Question: But why is PRR/PBMD not in the list of "More than a dozen active immunotherapies are in late-stage development in Table 1." Note that none of these trials relate to ovarian cancer. Also Prima is much more advanced than these. Prima needs to improve its marketing. Maybe the data of Phase 2b before year end will put it on the map.
Important points of the article:
“Seeing the approval of immune therapy treatments really working in patients with very advanced-stage disease, where you would expect the immune system wouldn’t be so effective, has spurred a desire to rapidly test and bring forward novel reagents across different tumors, not just melanoma or prostate cancer, that will really make a difference in the lives of patients with both advanced-stage disease and earlier-stage disease,”
Also comments about Stimuvax which I have posted below are important. If Stimuvax is approved PRR will fly because it targets the Mucin 1 antigen too.
"Oncothyreon has in its portfolio Stimuvax which is aimed at inducing an immune response in cancerous cells that express the protein antigen MUC1. Stimuvax has been in various stages of development for more than a decade, and now is entering the later stages of a phase III trial that has been under way for five years. Oncothyreon recently raised approximately $50.3 million through a stock offering, yet it is a small company that had 32 employees and nearly $24.7 million in losses last year. The company has partnered with an international giant, Merck KGaA in Darmstadt, Germany, which is conducting the pivotal phase III START trial in more than 30 countries.
It has completed enrollment of just over 1500 patients, and it has had two interim looks so far, both of which had efficacy and futility analyses performed. At both occasions, the Data Monitoring Board recommended that the trial continue. So we are in the final phases of this trial now. The guidance that Merck has given is that the top-line data from this trial should be available in the first part of next year.
Key results came from a phase IIB study involving 171 patients. Stimuvax demonstrated a 17.3-month median survival advantage for patients treated with the vaccine plus best standard of care versus those who received best standard of care alone (30.6 months vs 13.3 months, respectively), according to Oncothyreon.
“Importantly, both of these trials have a number of very long-term survivors,” said Kirkman. “There are eight or nine patients from the original phase II, a trial which was finished back in 2003, who are still alive today. And in our comparability trial, about half of those patients were still alive at five years.
Both of those numbers are way in excess of what you would normally expect in that disease setting. That’s why we’re all excited to get the results of the START trial and hoping that they’re confirmatory. We’ll know in about eight months.
When it comes to the immunotherapy field as a whole, Kirkman believes researchers remain excited about its possibilities, but that enthusiasm does not necessarily translate to raising capital.
The investor world is a little fickle and waxes and wanes on the subject,” said Kirkman. It took a very long time for anything to actually get approved, and we now have two approved immunotherapy products, Provenge for prostate cancer and Yervoy for melanoma, and that certainly has helped the field immensely.
Over the next 12 months, we’re going to get a number of additional phase III immunotherapy trials coming to a conclusion. If one or more of those is successful, then it will pretty much answer the question that immunotherapy works. And I’m hoping that Stimuvax is one of those compounds.”
Brainy
PRR Price at posting:
8.9¢ Sentiment: Buy Disclosure: Held
(20min delay)