You are considering treatment with MB-Vax Coley’s Vaccine Immunotherapies (hereinafter “IRT”) or another immune reaction protocol which are investigational treatments that are currently being studied for their potential anti-cancer effects at the Freeport Family Wellness Centre.
The purpose of this page is to explain the nature of the treatment and what is known about the possible benefits, side effects, risks, discomforts and inconveniences so that you can decide whether or not you wish to be treated. You are encouraged to ask any questions you have about this treatment and should be satisfied that all your questions are fully answered prior to signing the consent form. You are under no obligation to take the IRT treatment. You can take as much time as you need to decide choosing IRT treatment. In addition, you can discuss it with other people before you decide.
You have been diagnosed with a type/stage of cancer that is incurable by standard cancer treatment and you are choosing to take an investigational treatment to see if you can benefit from the IRT treatments. As the IRT you are considering has been used in only a limited number of patients, the full side-effect profile and benefits are unknown.
Background to IRT Treatment
Dr. William Coley (1862-1936) created a vaccine of Streptococcus pyogenes and Serratia marcescens produced by Park Davis Pharmaceuticals. Dr. Coley and other doctors like Dr. Josef Issels (1907-1998) continued to advance the work with Coley’s vaccine. Dr. Roger Rogers, Dr. Hal Gunn, Dr. Stephen Hoption Cann and other doctors researched killed bacterial immunotherapy treatments since 1982. Dr. Kevin Bethel continues to work with Coley’s vaccine produced in Canada by MB-Vax and several other immunotherapies.
The work taken together, a specific pattern of clinical benefit was noted, leading to the Immune Reaction Therapy (IRT) treatment theory. “Immune Reaction” in this treatment means therapy activating the innate (non-specific) immune system affected by the cancer. Detailed review of the results of treatment of patients with various types of cancer have documented benefit of ITR therapy. However, formal clinical trials have not been done, although such trials are currently being planned.
Based on these clinical observations, a company MB-Vax produced a new generation of Coley’s Vaccine, comprised of killed bacterial preparations, ideally targeted to specific cancer sites and to test this hypothesis (and thus, the potential benefit of these immunotherapy treatments) in animal and human studies. The Coley’s Vaccine is produced at MB-Vax in Toronto was under GLP standards. The results of clinical observations are very promising.
While we know that similar immunotherapy treatments have been used in hundreds of cancer patients, and that Coley’s Vaccine was manufactured in a similar way, IRT have been used in only a limited number of cancer patients to-date and therefore, the full side-effect profile is unknown. No significant side effects have been reported in patients treated to-date.
Depending on the locations of the tumour metastasis involvement, your physician may choose to combine the MB-Vax Coley’s IRT Vaccine with other standard commercially available vaccines to further enhance the site specific immunotherapy nature of the IRT preparation. Your IRT program will be individualized for your unique cancer situation.
Your physician is aware of the preliminary nature of the evidence, the investigational nature of IRT and their unknown side-effect profile, and has requested to supply him/her with a IRT on compassionate grounds in hopes that it will be of benefit to you, although such benefit is unknown.
IRT Side effects
As mentioned above, IRT have been used in a limited number of patients and therefore, their full side-effect and toxicity profile is unknown. Side-effects are possible with all medications, and drug interactions can be unpredictable, especially if you are on other investigational drugs. Interactions, if any, are not defined or known. Patients known to have had an allergic reaction to an immunotherapy treatment in the past should not take this treatment. Pregnant patients should not take this treatment as the effects in pregnancy are unknown. Also, nursing mothers should not take this treatment as its effects on breast milk are unknown.
One serious potential side-effect of any injectable drug is a life-threatening allergic reaction, which, although uncommon, is possible with any injectable drug.
Please report any unusual symptoms or signs immediately to your doctor.
IRT is provided on a compassionate basis as a result of an arrangement between your doctor and MB Vax (Canada) for life-threatening cancer which cannot be satisfactorily treated with standard approved medical treatment. All medications, laboratory fees, physician fees and hospital costs, including all costs related to any side-effects or possible side-effects attributable to the IRT will be your responsibility.
Voluntary Participation and Availability of IRT Treatment
Your participation in this treatment is completely voluntary. You are free not to choose it or to discontinue treatment at any time. Withdrawing from this treatment will not harm your relationship with your doctors. Your doctor may choose to terminate treatment with IRT if it is deemed detrimental or not helpful to you at any point in time. Also, please note that there is no implicit guarantee or representation of availability of these medications on a long-term basis.
If, as a direct or indirect result of the treatment or treatment procedures, you suffer any side effects which results in you incurring extra medical treatment, illness or death, The Freeport Family Wellness Centre and its employees are not liable to you and Coley’s MB-Vax carries no product liability risk insurance for the use of Coley’s Vaccine by your doctor. The Family Wellness Centre and its employees can’t be held accountable for any type of unwanted effect, adverse event, or consequence resulting out of the compassionate use of these products. The cost for treatment of any side effect(s) will be your responsibility.