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We're very thankful for the results our patients have achieved. There can be nothing more gratifying to us than to see our patients beating the odds. While we cannot help
every patient, so far we have been able to see the great majority of our patients do significantly better than with previously
available treatments. If that ever changes we will close our doors. It is important for patients evaluating
these results to note several things. First, these are from a small number of patients so far and because of that they
are not "statistically significant," that is, they do not come from a large enough group of patients to confidently
predict future outcomes. We're still very new and we're steadily building toward larger numbers. Second, these
data are not from controlled clinical trials. Currently this is simply an off-label treatment offered in our independent
medical practice. So while we are very thankful for these results and even a little bit proud of them, they do
not constitute controlled clinical data and we do not represent them as such. Having said those things, we're happy
to share exactly how we're doing. Please note several definitions and parameters. First, these outcomes
also include our patients with stage 4 and late stage 3 cancers, which most trials won't include because of their much lower
chance for successful treatment. Second, we have defined successful responses as either complete response (no evidence
of remaining cancer), partial response (significant reduction in size or volume of tumors), or stable disease (no significant
increase or decrease in tumor mass, and no new metastases) using the standardized criteria of the World Health Organization.
Patients with an initial ECOG performance status of 0, 1, or 2 are included. We do not include patients who do not follow
the treatment program for at least eight full weeks or who do not return for at least an initial follow-up visit, although
for the sake of honesty we do include unsuccessful outcomes from patients who did not return for follow-up but whom we know
followed the treatment program and had clear radiologic evidence of disease progression.
As of mid June 2010, our successful response rates
have been as follows. Malignant melanoma
All patients, 78% / Patients with stage 4 or 3c disease, 71% Pancreatic adenocarcinoma 80% (all patients stage 4 or inoperable stage
3) Colon & rectal cancer 75%
(all patients stage 4 or 3c) All diagnoses combined
81% In the one patient
whose pancreatic cancer was not controlled, it is noteworthy that the large primary tumor was significantly reduced at two
months and gone at four months, but pulmonary metastases continued to grow slowly. Successful responses have also been
achieved in all patients evaluated so far with malignant fibrous histiocytoma (2 patients), desmoplastic small round cell
tumor (1 patient), mesothelioma (1 patient), prostate cancer (1 patient), squamous cell carcinoma (1 patient, head & neck
region), non-Hodgkin's lymphoma (1 patient), and non-small-cell lung cancer (1 patient). Many additional patients are currently in treatment,
and these results will be updated periodically as information becomes available. Also, as of February 2010 we are offering
appropriately selected patients an additional agent in combination with the interferon and lovastatin. This may have
further impact on outcomes as data become available later this year. Two trends are becoming very clear even in this early experience. First,
there has been a dramatically lower incidence of new distant metastases in patients using this treatment program
(not a statistically significant finding at present), suggesting that it may have potential to prevent seeding of new metastases.
Thus the treatment may have its greatest benefit if instituted before too much time has passed and cancer has spread to distant
sites. Second, patients whose overall health has been extensively debilitated by either cancer progression or cytotoxic
treatments have far less chance of a successful outcome. Therefore, patients for whom our treatment program is a viable
option may have better chances if it begins earlier while overall health is still good. These observations are not statistically
significant and do not constitute outcome data from controlled clinical trials. We hope that this honest information, even though preliminary, can be helpful
to you.
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