I’m not going to exhaust too much research time on this. But I’ll address specifically the article claims.
Again, as with my answer to Are the hospitals known as The Cancer Treatment Centers of America really effective? I will give the company itself the benefit of the doubt, because this was not an official press release put out by the company. Instead it is an article posted in blog format by an non-medical/healthcare organization.
Still, here’s red flag #1:
â€œItâ€™s a really big thing,â€ says Levy, a biotechnology entrepreneur who was formerly CEO for Biokine Therapeutics. â€œIf you give chemo, apart from the really nasty side effects, what often happens is that cancer becomes immune [to it]. The tumor likes to mutate and develops an ability to hide from the treatment. Our vaccines are also designed to overcome that problem.â€
Putting aside my bias against describing a cancer vaccine as “a really big thing” (this could be a language issue) — Levy, who is the company’s CFO (where is the chief medical / scientific officer? Medical director? Why aren’t they being quoted?) — attempts to describe the evolution of metastasis that then leads to a false claim (if he were in the U.S. governed by FDA’s mandates.)
There is no data from the company that suggests the vaccines were designed to “overcome that problem” — and which problem, exactly? The “immunity” problem? The “mutation” problem? The “ability to hide from treatment” problem? Each of these could be specific traits to a cancer cell, or according to Levy, would collectively describe one cancer cell. These can also be traits for either solid tumors or liquid tumors. But Levy is vague, when the investigational drug is being targeted for development against multiple myeloma, a blood cancer (liquid tumor.)
Red flag #2 Claim of “Breakthrough”
Is this “breakthrough” describing the idea of using a vaccine against cancer? No: Cancer vaccines aren’t a breakthrough. The immunotherapy concept has been around for decades. http://www.cancer.gov/cancertopics/factsheet/Therapy/cancer-vaccines
Is this “breakthrough” describing the application of the vaccination concept against a specific cancer, namely multiple myeloma? No: As of November 15, 2011 there are 16 different cancer vaccine trials actively targeting multiple myeloma (Vaxil Bio’s trial is listed too). http://www.cancer.gov/clinicaltrials/search/results?protocolsearchid=6406649
Is this “breakthrough” describing a novel target? No: The MUC1 gene has been described back in 1984 when it was first observed in human breast carcinomas: http://www.ncbi.nlm.nih.gov/pubmed/6094338?dopt=Abstract&holding=npg
Is this “breakthrough” describing a particular characteristic of the investigational target? Maybe: According to the company’s website: “Unlike other vaccines which target the entire MUC1 protein or other domains, ImMucin does not contain any non-specific epitopes, which could dilute and disturb specific antiâ€“cancer immunity. ImMucinâ„¢ was shown to selectively be expressed on tumor cells, thereby ensuring specific anti-cancer activity.” http://www.vaxilbio.com/index.php?option=com_content&view=article&id=18&Itemid=27
Hardly a breakthrough,
may be an interesting agent to add to the mix in a cancer that currently has multiple therapeutic options (including antibody-based therapies considered as “novel” agents — see http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001609/),
with limited clinical trial involving more than 15 patients in one site http://www.vaxilbio.com/index.php?option=com_content&view=article&id=24&Itemid=37
Free advice for the company: I’d save the big claims language until I see progress free survival and overall survival data…. because isn’t a true breakthrough grounded in patients getting the outcomes that matter the most to them — an acceptable balance between extended quantity of life with a reasonable quality of life?