Research
We
believe very strongly in properly conducted medical research. Because of the responses to this off-label treatment that
we continue to see in our patients, we hope to initiate formal clinical trials in the near future to scientifically evaluate
this treatment as applied to several of the malignancies where we've seen best results. We are an independent medical
practice without government or industry funding, and so at the present time we are unable to have the very substantial financial
resources and personnel to initiate a formal research arm. We expect that in the near future collaborative
efforts and other developments will make this possible. (Some may notice that a preliminary research submission
with the National Institutes of Health was temporarily withdrawn at our own initiative. This is because IRB approval
will require significant resources not currently available to us.)
A major step toward those
research and development goals began in May 2018 with the licensing of the underlying patent to a pharmaceutical firm with
plans to fully develop its potential. We expect that more details will be available before long. In the meantime,
this practice is the only clinic authorized to offer this combination immunotherapy.
We wish to make sure potential
patients understand that the program offered in this practice is off-label treatment in a medical practice and not a
formal clinical trial. Of course, FDA regulations specifically allow off-label treatment and it is done routinely
in cancer clinics across the nation. While we continue to see very gratifying results in our patients, they do not constitute
controlled clinical data and we do not represent them as such. You can read more about our results by clicking on the
"Results" page on this web site. Furthermore, we adhere strictly to FDA regulations and voluntarily keep them
informed of our status and outcomes.
When formal clinical trials are instituted, one thing will not change.
The care of our patients, including those who don't qualify for clinical trials, will always be our highest priority and the
only reason for the existence of this clinic.
Veterinary Applications
As of July 2013 we have achieved excellent response in our
first veterinary patient, a dog with a large and symptomatic colon cancer. (Please be assured that animals are never
present at any time in our clinic, and also that our non-human patients will always receive the specialized care they deserve
from a qualified veterinary doctor.) We have reason to expect that this treatment method may prove successful against
a variety of cancers in other mammals, especially dogs and horses, and we look forward to veterinary applications playing
an important part in future research and in compassion for animals and the humans who love them.
What's Next
We're already working on the next wave of treatment innovations --
further advances that can build upon this very unique treatment technique once it has been properly evaluated and its effectiveness
fully demonstrated in formal clinical trials. Even though some of these things will take ten to fifteen years to become
widely available, they're in active planning now and we think they have exciting potential. Here's a glimpse at some
of the work currently in development or active planning:
- Treatment of cancers occurring primarily in children
- Combination
of this technique with new agents which can interact with other relevant ligands/receptors to restore specific immune system
functions
- Oral/transmucosal interferon delivery, which may reduce side effects and cost even further, simplify treatment,
and allow its use in more places around the globe
- Methods to achieve more consistent delivery to brain tissues, thus allowing
better treatment of primary brain tumors and metastatic lesions
- Optimizing the combination of this treatment with traditional
chemotherapy and other existing therapies where appropriate, to define which cancers do best with that approach and what dosages
and timing work best. We are especially interested in beneficial agents which may be inexpensive, well tolerated with
low toxicity, readily available, independent of need for intensive technology and specialized facilities/equipment, and suitable
for outpatient use.
- Precisely characterizing the immunologic and cellular mechanisms involved, since understanding how the
treatment works in the body may lead to improving it further and designing other effective targeted approaches
- Pre-treatment
with cancer antigen specific vaccines
- Effective, sensible, and cost-efficient prevention regimens for individuals
at high risk for certain cancers
The process involved in testing and approving each new facet of treatment is necessarily
meticulous for both scientific and ethical reasons, and that takes time and hard work and resources. But we think the
promise of better cancer treatments available to more people is worth everything we can give it, and we also think it's pretty
exciting.