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GenSpera's CEO Shares Insight on Unique Properties and Targeting of Lead Drug G-202, Based on the Thapsigargin Toxin

POINT ROBERTS, Wash. and NEW YORK, Aug. 5, 2014 /PRNewswire/ --, a global news source covering leading sectors including biotech, issues an exclusive Q&A interview with Dr. Craig Dionne, PhD, GenSpera's (OTCQB: GNSZ) CEO. Dr. Dionne discusses the company's lead drug G-202 and how they have taken a powerful toxin named thapsigargin to selectively target and kill cancer cells.

He also shares insight into the key points that make them different from competitive drugs available on the market for certain cancers.

Craig for readers unfamiliar with your company, can you explain the basis for your lead drug G-202 and how it works?

A: Dr. Craig Dionne, PhD, GenSpera CEO
There are really two important characteristics that distinguish G-202 from other chemotherapeutic agents. First, the active ingredient in G-202 is much more potent than other anti-cancer drugs and kills in a way that does not allow tumor cells to escape being killed. Second, G-202 is designed as a pro-drug that is expected to release the active ingredient only at the tumor itself, thereby maximizing anti-tumor effect and minimizing side effects.

And in particular can you explain how the targeting kills the tumor only and give us insight into the safety profile?  

A: Dr. Craig Dionne, PhD, GenSpera CEO
G-202 is designed so that it may be activated by the enzyme PSMA that is found at high levels in the blood vessels of almost all types of solid tumors, on the surface of prostate cancer cells and at very few other places in the body. G-202 circulates safely in the bloodstream until it comes in contact with PSMA which releases the active ingredient, 12ADT, which then falls into the tumor and does not come back into the bloodstream to cause toxicity elsewhere in the body. G-202 is administered to patients as an IV infusion over about one hour on three consecutive days – this dosing regimen is repeated at 28-day intervals. In keeping with the way G-202 is designed, patients experience very minor and easily managed side effects of nausea on days of drug administration, fatigue for a few days and a minor temporary rash. Importantly, G-202 has no effect on the bone marrow so there is no immunosuppression or anemia. This lack of significant side effects implies that we should be able to combine G-202 with other anti-cancer agents to maximize killing of the cancerous tumors in patients.

The company just recently released G-202 hepatocellular carcinoma ("HCC", which is liver cancer) clinical trial data at two prestigious industry conferences. Can you summarize the results released and also how has the data been embraced by your industry peers?

A: Dr. Craig Dionne, PhD, GenSpera CEO
We are testing G-202 in hepatocellular carcinoma patients who have had tumors regrow after being treated with sorafenib, which is the only approved drug for this patient population. Those patients who fail sorafenib and subsequently enter clinical trials for other experimental drugs usually have documented tumor regrowth at only two months. In our G-202 study we found that 80% of patients exhibited disease stabilization (no tumor regrowth) at 2 months. We also demonstrated that a significant proportion of patients, approximately 30%, have tumors stop growing for at least six months with one patient still receiving drug two years after coming into the trial. We then used a sophisticated imaging technique that visualizes blood flow through the tumor in a patient before starting our drug and again after two cycles of treatment to show that G-202 dramatically diminishes blood flow to the tumor, presumably by destroying the tumor blood vessels. The consensus among our industry peers is that G-202 is an active drug that does exactly what it is designed to do and at doses that are very well-tolerated by the patients.

Can you talk about the multiple cancers that G-202 can potentially treat and the kind of market opportunity each represents?

A: Dr. Craig Dionne, PhD, GenSpera CEO
We expect G-202 to be useful in a wide range of malignant tumor types, which covers a multi-billion dollar industry opportunity for GenSpera. There are approximately 240,000 new cases of prostate cancer diagnosed in the US each year. The market for prostate cancer drugs is expected to reach $6.7 billion by 2020. Hepatocellular carcinoma is the third largest cancer killer worldwide with an expected market size of $1.5 billion by 2019. Glioblastoma is a smaller market but sales of the approved drug Avastin in those patients is expected to reach $460 million by 2017. However we view glioblastoma as a proof of concept for treating brain tumors; if successful, we expect that G-202 could be used to treat lung and breast cancers that metastasize to the brain, which is a 10-fold larger market than glioblastoma alone.

How would you describe the G-202 proof of concept to-date in terms that an average reader could understand, outside of the scientific community?

A: Dr. Craig Dionne, PhD, GenSpera CEO
G-202 is designed to be activated only within the blood vessels of tumors and to kill those blood vessels directly, thus starving the tumors to death. We used a very sophisticated imaging technique to demonstrate that G-202 treatment nearly obliterated tumor blood flow in a liver cancer patient after only two cycles of treatment. These results bode well for our prostate cancer and glioblastoma (brain cancer) clinical trials, which use exactly the same dosing regimen.

Craig with your recent data on hepatocellular carcinoma (HCC or liver cancer) can you tell our readers how that compares with the current drug in the market?

A: Dr. Craig Dionne, PhD, GenSpera CEO
Sorafenib is the only approved drug for HCC and is used as the first line chemotherapy option. G-202 has only been tested in patients who have had tumor progression while on sorafenib and who are obviously patients of a later cancer stage. The fact that we are seeing positive signs of drug activity in this later stage patient population implies that we should see good activity when we test the drug in earlier stage patients. Certainly the G-202 side effect profile is much better than sorafenib, which causes nausea, neutropenia and hand-foot syndrome (blistering and peeling of palms of hands and soles of feet) in a significant proportion of patients.

In closing can you summarize the next steps and estimated time-line forbringing G-202 to market?

A: Dr. Craig Dionne, PhD, GenSpera CEO
We continue to evaluate G-202 in the ongoing HCC, glioblastoma and prostate cancer trials, which are all considered early-stage single-arm studies. Our next trial with G-202 will likely be a small randomized Phase IIB study in combination with sorafenib or in combination with trans-arterial chemoembolization, both of which would be in much earlier stage cancer patients than those we have treated to date. Either study should be complete within two years at which time we could begin a Phase III registration study so we are likely to be six years away from commercialization in HCC. However, if our data is really positive in the glioblastoma trial, we likely could be approved a year or two earlier in that indication.  In both cases as we report strong progress to the market, a strategic partnership with a major industry player is a possibility prior to receiving FDA approval.

Watch the Corporate Video:

Dr. Craig A. Dionne, PhD, President and CEO
Craig A. Dionne, PhD, is one of Genspera's founders and has served on the board since November 2003. He has over 25 years of experience in the pharmaceutical industry, including direct experience in identifying promising oncology treatments and bringing them through the clinic. He served for several years as VP Discovery Research at Cephalon, Inc. (now Teva Pharmaceuticals), a biopharmaceutical company, where he was responsible for its oncology and neurobiology drug discovery and development programs. Dr. Dionne also served as Executive Vice President at the Prostate Cancer Research Foundation. In addition to extensive executive experience, Dr. Dionne's productive scientific career has led to six issued patents and co-authorship of many scientific papers. Dr. Dionne received his PhD from the University of Texas at Austin in 1984.

About GenSpera (GNSZ):
GenSpera's technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a pro-drug delivery system that provides for the targeted release of drug candidates within a tumor. Unlike typical chemotherapeutic agents, thapsigargin results in cell death irrespective of the rate of cell division, which may provide an effective approach to kill both fast- and slow-growing cancers. GenSpera's lead drug candidate, G-202, is activated by the enzyme PSMA, which is found at high levels in the vasculature of liver and glioblastoma cancers and in the vasculature of almost all other solid tumors. G-202 is therefore expected to have potential efficacy in a wide variety of tumor types.

G-202 Phase II clinical trials are underway in hepatocellular carcinoma, glioblastoma and prostate cancer patients.

For more information, please visit the company's website:
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