Biotech News Alert: GenSpera's (OTCQB:GNSZ) CEO Shares
Insight on Unique Properties and Targeting of Lead Drug G-202, Based on the
Thapsigargin Toxin
POINT ROBERTS, Wash. and NEW YORK - August 5, 2014
(Investorideas.com Biotech Newswire) Investorideas.com, 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.
Q: Investorideas.com
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.
Q: Investorideas.com
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.
Q: Investorideas.com
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.
Q: Investorideas.com
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.
Q: Investorideas.com
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.
Q: Investorideas.com
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.
Q: Investorideas.com
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.
Read this release
in full at http://www.investorideas.com/CO/GNSZ/news/2014/08051.asp
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: http://www.genspera.com
or follow on Twitter @GenSperaNews.
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