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Thursday, August 28, 2014

GenSpera (OTCQB:GNSZ) Media Advisory; "Targeting thapsigargin towards tumors" Published in Steroids

GenSpera (OTCQB:GNSZ) Media Advisory; "Targeting thapsigargin towards tumors" Published in Steroids

SAN ANTONIO - August 28, 2014 (Investorideas.com Biotech Newswire) GenSpera, Inc. (OTCQB:GNSZ), a leader in developing prodrug therapeutics for the treatment of cancer, announces the recent publication of the article "Targeting thapsigargin towards tumors" in the journal Steroids.

The recent article co-authored by Doan, et al. (see full reference below), reviews the evolution and development of GenSpera's prodrug technology platform that is designed to deliver the potent, cytotoxic activity of thapsigargin (from the plant Thapsia garganica) directly to tumors. These efforts led to the development of mipsagargin (G-202), which is now in Phase II clinical trials in liver cancer and brain cancer.

The article details the discovery and isolation of thapsigargin, the elucidation of its molecular structure, and determination of its biochemical and pharmacological activities.
These efforts revealed the potential utility of thapsigargin as a potent, but non-selective anti-cancer agent. It was recognized that in order to harness the profound cytotoxic activity of thapsigargin, one would need to develop a way of delivering it specifically to tumors in order to avoid side effects.

The paper also goes on to describe the medicinal chemistry efforts to develop derivatives of thapsigargin in order to create protease-activated prodrugs that could be activated only within the tumors. The in vitro and in vivo experiments led to a number of potentially useful prodrugs directed to the tumor-selective enzymes PSMA, PSA and hK-2. Mipsagargin is the most developmentally advanced drug candidate and is activated by the enzyme PSMA, which is found in the blood vessels of almost all solid tumors.

The review highlights the drug development success that can be achieved through a multidisciplinary and multinational collaboration between academic laboratories and an industrial partner.

Targeting thapsigargin towards tumors
Steroids, available online 24 July 2014, Nhu Thi Quynh Doan, Eleonora Sandholdt Paulsen, Pankaj Sehgal, Jesper Vuust Møller, Poul Nissen, Samuel R. Denmeade, John T. Isaacs, Craig A. Dionne, Søren Brøgger Christensen

See the manuscript/article in full at:  http://www.genspera.com/publications/2014_Steroids.pdf

And (In press: Doan NTQ et al. Targeting thapsigargin towards tumors. Steroids (2014) http://dx.doi.org/10.1016/j.steroids.2014.07.009)


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.

Company presentations are available at: http://www.genspera.com/.

Watch the Corporate Video: http://youtu.be/jULjEul-mBk

Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements. Investors are cautioned that statements in this press release regarding potential applications of GenSpera’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties will be detailed from time to time in GenSpera’s periodic reports filed with the Securities and Exchange Commission.

CONTACT:
Company:
Craig Dionne, PhD, CEO
GenSpera, Inc.  (210) 479-8112                                     

Investors: 
Steve Gersten
Capital Markets Group
Steve@CapMarketsGroup.com
+1-813-926-8920

Media:
Dawn Van Zant
(800) 665 0411

Visit this company: www.genspera.com

More info on GNSZ at Investorideas.com Visit: http://www.investorideas.com/CO/GNSZ/

Disclaimer/Disclosure: Investorideas.com newswire is a third party publisher of news and research as well as creates original content as a news source. Original content created by investorideas is protected by copyright laws other than syndication rights. Investorideas is a news source on Google news and Linkedintoday plus hundreds of syndication partners. Our site does not make recommendations for purchases or sale of stocks or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated by featured companies, news submissions, content marketing and online advertising. Contact each company directly for press release questions. Disclosure is posted on each release if required but otherwise the news was not compensated for and is published for the sole interest of our readers. More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp. Disclosure: Genspera (GNSZ) has engaged Investor Ideas for PR and news publication effective June 18, 2014 (compensation of five thousand per month and average of eleven thousand five hundred 144 shares per month)
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894. Global investors must adhere to regulations of each country.


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Thursday, August 14, 2014

GenSpera (OTCQB:GNSZ) to Present at Rodman & Renshaw 16th Annual Global Investment Conference



Biotech News Alert: GenSpera (OTCQB:GNSZ) to Present at Rodman & Renshaw 16th Annual Global Investment Conference

CEO to Present Significance of Announced Clinical Trial Results for Lead Drug G-202 Treating Hepatocellular Carcinoma (HCC) Patients to Wall Street Audience

SAN ANTONIO, Texas, August 14, 2014 –  (Investorideas.com Biotech Newswire) GenSpera, Inc. (OTCQB:GNSZ), a leader in developing prodrug therapeutics for the treatment of cancer, announces it will be presenting at the Rodman & Renshaw 16th Annual Global Investment Conference. The conference will be held September 8-10, 2014 at the New York Palace Hotel in New York.

The conference is attended by public companies, institutional investors, sophisticated private investors and industry executives.

GenSpera will be presenting at 12:05 pm Tuesday, September 9th. The Company will discuss the significance of the recently announced HCC clinical trial update for G-202, its lead drug candidate, as well as provide a corporate overview. The company has released interim results from the Phase Ib and ongoing Phase II study in hepatocellular carcinoma (HCC) patients who had previously progressed on, or who were intolerant of sorafenib (Nexavar®, a drug co-developed and co-marketed by Bayer and Onyx Pharmaceuticals, an Amgen subsidiary).  Impressively, 80% of patients treated with G-202 had stable disease (no tumor growth) at two months and 50% of patients exhibited stable disease at 4 months on study. In addition, imaging analysis demonstrated impressive blockade of tumor blood flow in the single patient evaluated by this method to date.
 
Hepatocellular carcinoma (HCC) is currently the sixth most common malignancy in the world and the third leading cause of cancer-related mortality worldwide.

Craig Dionne, PhD, GenSpera's CEO said of the pending conference,” I am excited to share the recent data and results for G-202 and its efficacy and safety analyses on patients to date. G-202 has potential to treat multiple cancers including prostate cancer and glioblastoma but our primary focus is currently hepatocellular carcinoma (HCC). The liver cancer data we recently presented at APPLE and other scientific conferences was overwhelmingly embraced by our peers; now this conference creates an opportunity to explain the significance and the promise it holds to the investment community.”

About the conference: http://www.rodm.com/  


About GenSpera
GenSpera’s technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a prodrug 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 both hepatocellular carcinoma and glioblastoma patients.

For more information, please visit the company’s website: www.genspera.com or follow us on Twitter @GenSperaNews.

Company presentations are available at: http://www.genspera.com/

Watch the Corporate Video:

Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements. Investors are cautioned that statements in this press release regarding potential applications of GenSpera’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties will be detailed from time to time in GenSpera’s periodic reports filed with the Securities and Exchange Commission.

CONTACT:
Company:
Craig Dionne, PhD, CEO
GenSpera, Inc.  (210) 479-8112                                     

Investors: 
Steve Gersten
Capital Markets Group
Steve@CapMarketsGroup.com
+1-813-926-8920

Media:
Dawn Van Zant
(800) 665 0411

Visit this company: www.genspera.com

More info on GNSZ at Investorideas.com Visit: http://www.investorideas.com/CO/GNSZ/

Disclaimer/Disclosure: Investorideas.com newswire is a third party publisher of news and research as well as creates original content as a news source. Original content created by investorideas is protected by copyright laws other than syndication rights. Investorideas is a news source on Google news and Linkedintoday plus hundreds of syndication partners. Our site does not make recommendations for purchases or sale of stocks or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated by featured companies, news submissions, content marketing and online advertising. Contact each company directly for press release questions. Disclosure is posted on each release if required but otherwise the news was not compensated for and is published for the sole interest of our readers. More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp. Disclosure: Genspera (GNSZ) has engaged Investor Ideas for PR and news publication effective June 18, 2014 (compensation of five thousand per month and average of eleven thousand five hundred 144 shares per month)
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894. Global investors must adhere to regulations of each country.



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Wednesday, August 6, 2014

Aethlon Medical (OTCQB: AEMD) CEO Note: A Novel Strategy To Address Ebola

Medical Technology Breaking News: Aethlon Medical (OTCQB: AEMD) CEO Note: A Novel Strategy To Address Ebola

SAN DIEGO - August 6, 2014 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB:AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.



The current ebola outbreak in West Africa demonstrates the urgent need for therapeutic strategies to defend against emerging pandemic threats. It also highlights why the Department of Health and Human Services (HHS) has shifted the focus of government biodefense and pandemic threat initiatives toward broad-spectrum therapies able to target multiple pathogens. At present, a majority of all infectious viruses are not addressed by drug therapies, which are designed to inhibit or block replication of a single viral species.

At Aethlon Medical, we are intersecting advanced biology with modern plasma membrane technology to rethink the treatment of viral pathogens. The result is the Aethlon Hemopurifier®, a therapeutic device that has been validated to capture a broad-spectrum of viral pathogens and immunosuppressive proteins through affinity binding to a unique high-mannose structure that is co-opted from the host (the infected individual) as a means for viruses to evade detection of the host immune system. We have also discovered that this signature exists on tumor-secreted exosomes that promote cancer progression.

We believe our Hemopurifier® is the most advanced and perhaps only true broad-spectrum countermeasure against emerging pandemic threats such as ebola, and viral threats that could be weaponized to purposely infect civilian and military populations. Our belief is supported by human clinical outcomes and supporting in vitro studies conducted at leading government and non- government labs.

Last week, a story published on CNN.com (http://ireport.cnn.com/docs/DOC-1157208?ref=feeds%2Flatest), suggested that our Hemopurifier® might be an ebola treatment cure. In this regard, I want to clarify that we created the Hemopurifier® to provide a post-exposure treatment strategy to mitigate illness, suffering, and death resulting from exposure to viral pathogens. However, we do not represent that our Hemopurifier® is a cure for ebola. It is designed to augment the ability of the immune system to overcome infection and to increase the benefit of drug therapy in disease conditions where an antiviral agent might be indicated.

I also want to provide clarity on what Hemopurifier® studies have been conducted specific to the ebola virus. On October 17th, 2007, Dr. Laura Barrientos at the United States (US) Centers for Disease Control and Prevention (CDC), published a report entitled: "The Aethlon Hemopurifier®, A Novel Strategy to Address ebola and Marburg Haemorrhagic Fevers."

The report discussed the potential of the Aethlon Hemopurifier® as a treatment countermeasure against ebola and other filoviruses. An excerpt from the report follows:

"The Hemopurifier® is an extracorporeal device which converges hollow-fiber filtration technology with immobilized affinity agents to allow for the rapid physical removal of virus and soluble viral glycoproteins from the blood. The device basically mimics the natural immune response for clearance of circulating virus and viral toxins. Initial collaborative efforts between the CDC and Aethlon Medical have demonstrated rapid clearance of viral particles from cell culture supernatants (t1/2 20-120 min). The Hemopurifier® was also effective in removing soluble viral glycoproteins (t1/2 30 min). This knowledge represents the basis to further investigate in vivo the potential of the Hemopurifier® as a fast-acting post-exposure intervention to delay disease progression and, possibly, to improve survival. The data resulting from the CDC-Aethlon collaboration has led to further studies through a collaborative research and development agreement with the United States Army Medical Research Institute for Infectious Diseases (USAMRIID)." The full report can be accessed online at: http://www.aethlonmedical.com/assets/001/5017.pdf

In a follow-on disclosure, we reported that the USAMRIID studies documented that the Hemopurifier® captured approximately 50% of both wild type and mutant strains of ZEBOV (Zaire strain of ebola) from fluids during one hour in vitro studies. ZEBOV has the highest virus case-fatality rate, up to 90% in some epidemics, with an average case fatality rate of approximately 83% over the previous 27 years. USAMRIID, serves as the lead laboratory for the U.S. Medical Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. USAMRIID operates the only laboratory in the Department of Defense (DOD) equipped to study ebola and other highly hazardous infectious agents requiring maximum containment at bio-safety level four (BSL-4).

At present, we are preparing to launch the first FDA approved feasibility studies of Hemopurifier® therapy in the United States. Under the feasibility study protocol, we will enroll end stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy in an infectious disease model.

Successful completion of the feasibility study will set the stage for us to conduct pivotal studies required for market clearance to treat HCV and other viral pathogens.

The study will also contribute data toward the human safety challenge requirement to advance Hemopurifier® therapy as a broad-spectrum countermeasure against viral bioterror and pandemic threats (including ebola), whose lethality do not allow for the administration of clinical efficacy studies. We are actively investigating Emergency Use Authorization (EUA) approvals based on our previous human treatment experiences and broad-spectrum validation studies against viral pathogens. We are also exploring Humanitarian Use Device (HUD) pathways for orphan conditions that affect fewer than 4,000 individuals in the U.S. each year.

Should the outbreak of deadly viral pathogen provide us with opportunities to treat, we would first request clarity from the FDA that our response would not threaten our long-term clinical objectives in the United States. Additionally, we would request FDA interaction to provide feedback on data-points that could be collected to support future EUA and HUD approvals. In this regard, I want to share that we have initiated our dialog with FDA. The results of these discussions will determine whether we request an opportunity to treat those infected with ebola virus.


About Aethlon Medical
Aethlon Medical creates innovative medical devices to address life-threatening diseases. The Aethlon ADAPT™ (Adaptive Dialysis-like Affinity Platform Technology) establishes the basis for a new class of therapeutics that target the rapid elimination of disease enabling particles from the circulatory system of treated patients. The lead Aethlon ADAPT™ product is the Hemopurifier®, a device that addresses a broad-spectrum of viral pathogens as well as tumor-secreted exosomes that suppress the immune system of cancer patients. Aethlon is also operating under two government contracts with the Defense Advanced Research Projects Agency (DARPA) related the development of a medical device to reduce the incidence of sepsis. Exosome Sciences, Inc. is a majority owned Aethlon subsidiary that is advancing exosome-based strategies to diagnose and monitor cancer and infectious disease progression. Additional information can be found atwww.AethlonMedical.com

Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy or as a treatment for ebola, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in the DARPA contract, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:
James A. Joyce 
Chairman and CEO
 
858.459.7800 x301
 
jj@aethlonmedical.com

Jim Frakes 
Chief Financial Officer
 
858.459.7800 x300
 
jfrakes@aethlonmedical.com

Visit this company: www.aethlonmedical.com

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Disclaimer/Disclosure: The Investorideas.com newswire is a third party publisher of news and research as well as creates original content as a news source. Original content created by investorideas is protected by copyright laws other than syndication rights. Investorideas is a news source on Google news and Linkedintoday plus hundreds of syndication partners. Our site does not make recommendations for purchases or sale of stocks or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated by featured companies, news submissions, content marketing and online advertising. Contact each company directly for press release questions. Disclosure is posted on each release if required but otherwise the news was not compensated for and is published for the sole interest of our readers. More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp  
Disclosure: AEMD subscribes to the Investorideas newswire content publishing annual program (9700 per Year, paid quarterly) for news publishing.
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894. Global investors must adhere to regulations of each country.

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Tuesday, August 5, 2014

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

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.

Watch the Corporate Video: http://youtu.be/jULjEul-mBk


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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