Interview with Moshe Rogosnitzky, Director of Research, MedInsight^® Research Institute

Topic: The Use of OGF in Clinical Practice for Treating Cancer

How did you learn about OGF?

I first learned about OGF while scouring medical literature in search of non-toxic cancer therapies. I came across a lot of potential therapies, but many of them, upon closer inspection, turned out to either be too toxic or over-hyped or over-sold and of little clinical potential. I started investigating potential therapies in greater detail by travelling to the institutions where the research was being carried out and gaining a first-hand impression of the science, the integrity of the researchers, and more. It was sometime in 2001 or 2002 that I travelled to Hershey Medical Center in Pennsylvania to meet Dr. Zagon and explore his inventions in person.

What were your impressions of the visit?

First of all, I found Dr. Zagon to be a scientist of a very rare kind. His only motive was to help patients, and he’s devoted his career to nothing but that. He had no ulterior or financial interests. Every few minutes our meeting was interrupted by a phone call from an unknown patient calling him for free advice, and he made time for everyone. I remember him saying that nothing gives him greater pleasure than sitting in the lab and hearing that his inventions have been bringing relief from suffering patients worldwide.

I was even more impressed to discover that Dr. Zagon supported his own research by donating part of his salary back to Penn State University to enable the hiring of more lab personnel to further research activities. I have yet to find someone else who does that. All of this obviously led me to trust Dr. Zagon’s claims of what worked and what didn’t, and this has led to a wonderful cooperation which has brought great benefit to numerous patients worldwide.

When did you begin advising patients to use OGF?

Dr. Zagon guided me in the protocols he and his team designed, and I began advising physicians to use it in 2002. I’ve benefitted from gaining a lot of feedback from the physicians I consult with and then sharing that feedback with Dr. Zagon. This feedback has led to ongoing refinements in dose and method of administration. Another gratifying effect of the feedback is that it is leading to the advancement of OGF research. For example, we had fantastic feedback about the results of using OGF in ovarian cancer patients. After I passed this feedback on to Dr. Zagon, it led him and his team team to investigate this particular cancer more closely, and resulted in a recent publication (American Journal of Physiology, 2009 Jun;296(6)) of pre-clinical results demonstrating OGF’s excellent utility in targeting this deadly cancer.

How was it possible to obtain OGF outside of clinical trials?

Since OGF is an unpatented molecule, there is no problem in synthesizing it. The only issue is one of cost. Over the years there were a number of compounding pharmacies in the United States that used to prepare it – they purchased the OGF peptide from a specialist manufacturer in California. However, in 2003 that company shut down, and since then the cost of acquiring high-grade OGF has become very expensive. The U.S. pharmacies no longer supply it because they cannot afford to lay out the enormous amount of money necessary for a minimum order.

What is the benefit of GMP-grade OGF?

GMP grade means that the manufacturer has adhered to Good Manufacturing Practices and the product can therefore be prepared for human use. Non-GMP grade OGF is readily available, but government guidelines generally prohibit compounding pharmacies from using it. In Europe it is possible to obtain non-GMP-grade OGF. In Israel there is a pharmacy that prepares OGF from GMP-grade material, and this is the product that most of the patients I have monitored have been using.

Not long after I began recommending OGF, I was approached by a patient who was a senior figure in the Israeli Ministry of Health. She was diagnosed with stage 4 breast cancer, and was told she had only a few months to live. She declined chemotherapy and instead opted for low-toxicity therapies such as OGF and others. After about a year on OGF, during which time she continued working as normal, she convinced one of her colleagues to help ease the procedure for patients to obtain OGF and that is what happened. Incidentally, she lived for six years, and continued working normally until almost the very end.

How many patients have you monitored using it?

I don’t have an exact number, but I estimate that between the patients I have advised and those that were given OGF by the physicians I advised, the number is in the range of four to five hundred over the past eight years.

Which cancers did they suffer from?

The types of cancer have been numerous, including pancreatic, breast, ovarian, non-small-cell lung (NSCLC), glioblastoma, glioma, neuroblastoma, gastroesophageal, liver (hepatocellular carcinoma), metastatic melanoma, sarcoma, colon cancer, renal-cell carcinoma and hepatoblastoma, among others.

What is the optimal dose?

Clinical trials have used varying dosages. We have generally observed that 60 micrograms per k.g. of bodyweight injected sub-cutaneously (under the skin) twice daily works best. It is also the most practical route of administration for patients, since they can self-inject at home, using an insulin-syringe.

Which cancers does it work best for?

This is a difficult question to answer because these patients have not used it under clinical trial conditions, so there is no comparison group. Furthermore, every patient began using it at a different stage of his or her treatment , some of them at the very beginning, some almost at the very end. Typically everyone combined it with something else, whether chemotherapy, biological therapies, or other non-toxic therapies.

My impressions are that it works particularly well for ovarian cancer, melanoma, and non-small-cell lung cancer. There is a case of residual hepatoblastoma (a very rare type of liver cancer) where a cure was achieved in an infant. With pancreatic cancer, there are published studies that indicate it at least doubles life expectancy. The problem in pancreatic cancer is that the OGF receptors are not being produced as they should, and this limits its effect. In most other cancers, OGF production is not a problem. Dr. Zagon and his team are working on developing the possibility of correcting the OGF-receptor production-malfunction using gene-gun therapy, but this is still sometime in the future.

Is it possible to check the status of the OGF receptor?

Several pathology laboratories in the United States have begun checking the OGF receptor (OGFr) status in tumor samples. Very often, we see a finding of either over-expression or under-expression of this gene. The significance of these findings in clinical practice is not yet known. It stands to reason that if OGFr is over-expressed, then OGF may work better. However, this needs to be confirmed in formal trials.

Do you think OGF will ever be officially approved?

I would love to give an optimistic answer to that question. However, the reality is that drug development is driven by commercial interests. Since OGF itself cannot be patented, it is unlikely that a pharmaceutical company would invest the enormous resources necessary to gain formal FDA approval. There are companies working on developing analogues of OGF –new molecules that mimic OGF’s activity. If they succeed, there is hope that such a product would make it to market one day. There is no telling whether such a drug would be more or less effective than OGF is, that remains to be seen.

So do you see a purpose in all the research being done with OGF?

Absolutely. First of all it is entirely possible that a non-commercial entity will decide to finance the approval process for OGF. And I genuinely admire the tenacity of Dr. Zagon and Dr. McLaughlin in pursuing their research despite the lack of commercial potential. You can’t place a price on the comfort, quality of life, and extended survival gained by patients who have been helped by OGF. The gratification received by each positive report makes all the efforts worthwhile. Above all, people are always immensely grateful for having been provided with hope where there was none to be had. I think that is indeed the prime purpose of all those involved with OGF and related treatments.