In the world of pharmaceuticals, the approval of a new drug is largely a matter of its relative performance rather than an absolute performance. That is, the therapy in question doesn’t just have to work — it has to work as good, or better, than the treatments currently approved for a particular disease.
It’s a subtle but important nuance for up-and-coming biotech company PharmaCyte Biotech, Inc. (PMCB), which is not only developing what looks like a successful pancreatic cancer treatment, but a treatment that could indeed outperform the preferred therapies of Abraxane® plus gemcitabine (from Celgene Corporation), gemcitabine as a single agent (from Eli Lilly), and Tarceva® plus gemcitabine (made by Roche Holding subsidiary Genentech).
It’s not the potential spin on a lesser-used cancer drug — ifosfamide — that makes the PharmaCyte Biotech story so compelling right now, however. The story took an interesting and even more encouraging turn last week when PharmaCyte brought a pancreatic cancer veteran into the fold who also happens to have close ties with another one of the world’s leading authorities on the matter.
On Thursday of last week, PharmaCyte Biotech added Dr. Manuel Hidalgo to the company’s Scientific Advisory Board.
Dr. Hidalgo is one of Europe’s leading clinical and laboratory investigators in the field of pancreatic cancer. He presently heads the Gastrointestinal Cancer Clinical Research Unit at the Spanish National Cancer Research Centre (CNIO). Dr. Hidalgo is also the Director of the Clara Campal Oncology Center in Madrid, in addition to holding a post as professor of Oncology at the University CEU San Pablo, in Madrid. Between 2001 and 2009, he was the Co-Director of both the Drug Development and Gastrointestinal Oncology Programs at Johns Hopkins University.
It’s expertise and experience that could prove invaluable to PharmaCyte, and yet, there’s more to the story.
Dr. Hidalgo is also a co-founder and Chairman of the international Pancreatic Cancer Research Team (PCRT), and works with co-founder Dr. Daniel Von Hoff, who also serves as the Chief Development Officer of Translational Drug Development or TD2.
Dr. Von Hoff is renowned for all of his contributions to pancreatic cancer treatments, but he was a critical part of the development of the aforementioned gemcitabine and Abraxane plus gemcitabine, the current top therapy choices of oncologists to fight pancreatic cancer, and the drugs PharmaCyte aims to outperform with its treatment of Cell-in-a-Box® plus low doses of the anticancer drug ifosfamide, in upcoming Phase 2b clinical trials in Australia.
Moreover, Dr. Hidalgo has himself participated in the development of several cancer drugs, including the combination chemotherapy of Abraxane plus gemcitabine. He also led the early-stage testing of temsirolimus as a treatment for advanced kidney cancer, and Tarceva, which in combination with gemcitabine is currently approved to treat non-small cell lung cancer in addition to advanced pancreatic cancer.
In light of his experience with Tarceva, gemcitabine and Abraxane (not to mention his association with Dr. Von Hoff via the international Pancreatic Cancer Research Team), access to Dr. Hidalgo’s insight should further increase the odds that PharmaCyte Biotech demonstrates comparable, or even better, efficacy when comparing its results to the results Tarceva, gemcitabine and Abraxane plus gemcitabine generally achieve as a means of fighting pancreatic cancer. Indeed, there may be nobody better suited to help develop a drug than one of the creators of the drugs that serve as the current standard of care for pancreatic cancer patients.
As for the results the company has already created using ifosfamide as a pancreatic cancer treatment that’s catalyzed by its Cell-in-a-Box platform, they’re encouraging to say the least. According to the company, in comparison to gemcitabine, the treatment increased median survival from 28 to 44 weeks and percentage of one-year survivors from 18% to 36% in its phase 1/2 trial. It’s no wonder the U.S. Food and Drug Administration (FDA) granted the drug/delivery combination an orphan drug designation at the end of last year.
With all of that being said, while PharmaCyte is initially taking aim at pancreatic cancer and is preparing for a phase 2b or “mini” phase 3 clinical trial using its Cell-in-a-Box platform as a means of delivering anticancer agent ifosfamide, one can’t help but wonder if the addition of Hidalgo to the Scientific Advisory Board will also lay the groundwork for the development of other cancer treatments. Dr. Hidalgo has already expressed interest in the Cell-in-a-Box technology as a means to treat other solid tumors, such as liver cancer, and the company itself has been fleshing out how Cell-in-a-Box could be best utilized to treat symptoms associated with all abdominal cancers, including malignant ascites fluid (currently in preclinical trials at TD2) and pain (preparing for a phase 1/2 clinical trial at TD2), and the company is exploring using its platform technology to treat brain tumors as well.
Whatever is in the cards, PharmaCyte Biotech clearly added a power-hitter to its roster last week.
Read more articles and our research report on PharmaCyte Biotech atwww.smallcapnetwork.com.
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