Category: Investment, Biotech, Pharma
Biotech News Alert: Kareg Corporation Initiates Coverage on GenSpera (OTCQB:GNSZ) with a Speculative Buy Recommendation
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SAN ANTONIO - July 14, 2014 (Investorideas.com Biotech Newswire) GenSpera, Inc. (OTCQB:GNSZ), a leader in developing prodrug therapeutics for the treatment of cancer, announces that Kareg Corporation's Director of Research, Sheldon S. Traube, has issued the following research report on the company.
Sheldon S. Traube, Director of Research, Kareg Corporation, Initiating Coverage with a Speculative Buy Recommendation
Read the full report: http://www.genspera.com/press/140711_Genspera_research_report_July2014.pdf
GNSZ is attractive for speculative accounts seeking above-average appreciation potential based upon the following considerations:
Summary and Conclusion:
- GenSpera is focused on the development of prodrug cancer therapeutics based on a novel breakthrough proprietary technology platform which supports the development of a suite of drug compounds targeted at different cancer indications, as well as imaging applications. GenSpera's approach is supported by over $35M of funding ($15 million via various grants to Johns Hopkins and more than $20 million by the Company) and 15 years of research at Johns Hopkins Medical Center and other renowned research centers.
- Its unique cytotoxin kills cancer cells independent of cell division and is expected to eradicate cancer stem cells as well as slow and fast growing cancers.
- Its tumor-specific activation of drug minimizes side-effects normally experienced with other cancer drug compounds. Traditional and emerging treatments for many late stage cancers struggle with potency issues and/or side effects. Traditional therapies typically have serious side effects, face resistance, and have minimal effectiveness on slowly dividing cancer cells. Antibody drugs target high antigen expressing cells and generally have a lower probability of tumor kill. Anti-Angiogenesis compounds typically offer limited survival benefits and cause serious side effects.
- GenSpera's drug candidates are based on chemical derivatives of a plant cytotoxin, called Thapsigargin, which is a potent inhibitor of the intracellular sarcoplasmic/endoplasmic reticulum calcium ATPase (SERCA) pump. The inhibition of the transport protein causes intracellular Ca2+ (calcium) to rise significantly and trigger apoptosis (cell death). GenSpera masks Thapsigargin's toxicity in the blood stream and delivers and activates it only at the tumor site.
- GNSZ's lead candidate, G-202, should be useful against most tumor types. Its first targeted indication is liver cancer, the third largest cancer killer worldwide. G-202 is a prodrug where the active cytotoxin, 12ADT, is masked by a peptide complex until it binds to and cleaved by the targeted Prostate-Specific Membrane Antigen (PSMA), thus triggering apoptosis. Nexavar®, currently the only approved drug for this indication, has more than $700 million in annual sales.
- G-202 is showing excellent clinical results with Phase IB and early Phase II data in liver cancer, highly suggestive of clinical activity. Only a few easily managed and predictable side effects in Phase 1 were observed. Early Phase II data look promising with a benign side-effect profile and impressive clinical results in advanced liver cancer patients. Phase II clinical trial in liver cancer is ongoing. GNSZ is now using DCE-MRI imaging on newly-enrolled patients (in addition to X-ray), both at baseline and after treatment intervals that the company thinks could demonstrate the decreased blood flow to the tumor, and, thus, the successful killing of the cancerous cells. Typically in this very advanced liver cancer population, the shrinkage of the tumors are not visible on the X-rays due to intense scarring of the tissues.
- GenSpera's second targeted indication is glioblastoma, a form of brain cancer with high unmet need. GNSZ's drug does not need to cross the brain barrier.
- Both indications require smaller clinical studies and offer fast track to FDA approval.
- Phase II clinical trial in glioblastoma was initiated in Q1 2014.
- GNSZ's patented technology platform has additional applications in other large cancer indications as well as imaging applications.
- GenSpera's corporate strategy is to "de-risk" its products and thus harvest significant value via the development of drug compounds through Phase II clinical trials. GenSpera's strategy is to then monetize its efforts after conducting Phase II trials, through exit strategies, i.e., licensing or sale to "Big Pharma" without incurring the time, cost and risk of building a pharmaceutical marketing and sales organization. GNSZ has signed a number of NDA's with mid-size and "Big Pharmas". Drug development is increasingly being relegated to "junior companies" with "Big Pharma" willing to acquire the technology or drug after it has been de-risked. For example, in 2010, companies with Phase II assets were acquired at a mean price of $85 million with milestone payments of $55.2 million, and the potential of a double digit royalty percentage. Cougar Biotech, a former Bulletin-Board listed company was acquired by Johnson & Johnson in 2009 for $970M in cash for their prostate cancer drug (ZYTIGA™) which received FDA approval in April 2011.
- GenSpera has a robust global IP position, with a portfolio of filed and granted patents covering 12ADT and other derivatives of Thapsigargin, peptide "masking/targeting" sequences and their prodrug conjugates. The patents are owned by GenSpera with no royalties or milestone payments payable to any third party.
- GenSpera has an experienced and well-seasoned management and scientific team. Craig Dionne, PhD, CEO, has extensive experience in successfully identifying and bringing oncology treatments to the clinic while Senior Vice President of Research at Cephalon, Inc. (acquired by TEVA Pharmaceuticals). Its Board of Directors includes senior executives in the pharmaceutical industry, with deep mergers and acquisitions (M&A) experience.
- The company is expected to have steady news flow. Interim Phase II data are expected to be announced at the Apple Congress on Saturday, July 12, 2014. Positive interim data should positively impact the GNSZ stock price. Additionally, in the third quarter the company should initiate Phase II clinical trial in renal cell carcinoma, and in the first quarter of 2015 GenSpera expects to present interim data for ongoing glioblastoma trial.
- Based on the company's attractive growth prospects with a pipeline of products based upon its unique platform targeting large tumor applications; and strong development and experienced management team that has taken drugs successfully through clinical trials, we recommend the purchase of GNSZ stock for speculative accounts seeking long-term capital appreciation. Our target: more than a double within the next 12-24 months.
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.
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.
Craig Dionne, PhD, CEO
BPC Financial Marketing
Media: (800) 665 0411
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