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New Drug Slows HCC Progression in Phase 2 Study
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"The Phase II study results (n=25) demonstrate that the prodrug effectively stabilizes progression of HCC by reducing blood flow within tumors while not affecting blood flow within normal tissues.....we intend to move forward with a large, global Phase III trial.....Study participants experienced a median time to progression of 4.2 months, nearly twice the time demonstrated in prior studies with placebo or ineffective agents. Thirty-five percent of patients received 5 or more cycles of treatment with an average time on study of 7.1 months. Additionally, mipsagargin demonstrated decreased blood flow in liver tumors as measured by DCE-MRI.......Of the 20 evaluable patients, there were 13 responders (65 percent) showing stable disease (SD) after at least one treatment cycle (28 days), and 7 patients (35 percent) maintained SD for at least 5 treatment cycles. Furthermore, the reported median time- to-progression (TTP) of 4.2 months represents an improvement of approximately two months when compared to the previously published median TTP range of 1.4 to 2.7 months for patients who have failed Nexavar first-line therapy. Other reported efficacy results include a median progression-free survival (PFS) of 3.7 months, and a median overall survival (OS) of 6.6 months, with 8 patients still continuing in the study. "
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GenSpera Announces Positive Phase II Data for Investigational Agent Mipsagargin First-in-Class L
Agent is Well Tolerated in Liver Cancer Patients
http://www.prnewswire.com/news-releases/genspera-announces-positive-phase-ii-data-for-investigational-agent-mipsagargin-300021471.html
SAN ANTONIO, Jan. 16, 2015 /PRNewswire/ -- GenSpera Inc. (OTCQB: GNSZ) today announced the encouraging results of a Phase II study of mipsagargin (G-202), an investigational agent for the treatment of hepatocellular carcinoma (HCC). The results will be presented today (12:00 to 2:00 p.m. PST, Abstract #301) in a poster presentation at the 2015 Gastrointestinal Cancers Symposium in San Francisco, California.
The Phase II results demonstrated that mipsagargin appears to be effective and is well-tolerated by HCC patients. Mipsagargin targets the enzyme prostate-specific membrane antigen (PSMA), which is highly expressed in tumor vasculature and prostate cancer cells. The Phase II study results (n=25) demonstrate that the prodrug effectively stabilizes progression of HCC by reducing blood flow within tumors while not affecting blood flow within normal tissues.
"We are very encouraged with the positive results from this Phase II trial that demonstrate the tolerability and show indications of effectiveness of mipsagargin in advanced liver cancer patients," said Craig Dionne, PhD, chief executive officer at GenSpera. "Mipsagargin is a first-in-class agent with a novel mechanism of action that is unlike any other drug being tested in patients with advanced liver cancer. Based on the results of this study, we intend to move forward with a large, global Phase III trial."
Mipsagargin's targeted approach differs from other vascular targeting agents by destroying established tumor vasculature rather than slowing the growth of new tumor blood vessels. The PSMA-targeting agent is designed to minimize side effects commonly observed with other therapies, while maximizing activity against tumors.
"These results demonstrate the potential that mipsagargin has to treat one of the world's deadliest cancers," said Devalingam Mahalingam, MD, PhD, an oncologist at the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio and principal investigator of the study. "In addition to observing prolonged disease stabilization in some patients, we noted anecdotal evidence that patients had improved performance status with much less fatigue and side effects associated with other anti-cancer therapeutics."
With Phase II complete, GenSpera is designing a large, international Phase III study which will further define the anti-tumor potential of mipsagargin in liver cancer patients. More information on mipsagargin (G-202) can be found at www.genspera.com.
Hepatocellular carcinoma is the most common form of cancer that originates in the liver. In the United States, more than 33,000 new cases will be diagnosed in 2015. Globally, liver cancer is a primary public health issue with more than 700,000 people diagnosed and more than 600,000 deaths annually. It is the most common type of cancer in Southeast Asia and sub-Saharan Africa. A liver cancer diagnosis is often subsequent to other liver disease, making treatment of a highly compromised patient population particularly challenging.
Data Establishes Foundation for Continued Investigation
The Phase II study (Abstract #301) of mipsagargin was a multi-site, single arm study designed to assess time to progression and response rate to treatment. The study measured disease progression in 25 patients with advanced-stage liver disease and poor liver reserves who had failed first line treatment with sorafenib. Patients were administered episodic dosing of mipsagargin on the first three days of each treatment cycle. Study participants experienced a median time to progression of 4.2 months, nearly twice the time demonstrated in prior studies with placebo or ineffective agents. Thirty-five percent of patients received 5 or more cycles of treatment with an average time on study of 7.1 months. Additionally, mipsagargin demonstrated decreased blood flow in liver tumors as measured by DCE-MRI.
About GenSpera
GenSpera Inc. is a San Antonio-based biotech company that unlocks conventional thinking to conceive, design, and develop cancer therapies. GenSpera's technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a patented prodrug delivery system that provides for the targeted release of drug candidates within tumors. GenSpera's lead drug candidate, mipsagargin, was granted Orphan Drug designation by the US Food and Drug Administration (FDA) in 2013 for evaluation in patients with hepatocellular carcinoma (liver cancer).
For additional information on GenSpera, visit www.genspera.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.
Cautionary Statement Regarding Forward Looking Information
This communication may contain forward-looking statements. Investors are cautioned that statements in this document regarding potential applications of GenSpera's technologies or the future prospects of the company 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 and the acceptance of GenSpera's proposed therapies by the health community. 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.
SOURCE GenSpera
RELATED LINKS
http://www.genspera.com
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Encouraging phase 2 data supports GenSpera's development of cancer drug: H.C. Wainwright
http://www.investingnewsalerts.com/blog/encouraging-phase-2-data-supports-gensperas-development-of-cancer-drug-h-c-wainwright/
GenSpera (OTCMKTS:GNSZ), a development-stage pharmaceutical company, had its "buy" recommendation and $2.00 price target maintained at H.C. Wainwright (HCW), which pointed to encouraging phase 2 data for the use of mipsagargin, and its market potential.
Last week, GenSpera released the latest results from the Phase 2 clinical study for the use of mipsagargin as a second-line therapy in advanced hepatocellular carcinoma (HCC) at the 2015 ASCO Gastrointestestinal Cancers Symposium.
Of the 20 evaluable patients, there were 13 responders (65 percent) showing stable disease (SD) after at least one treatment cycle (28 days), and 7 patients (35 percent) maintained SD for at least 5 treatment cycles.
Furthermore, the reported median time- to-progression (TTP) of 4.2 months represents an improvement of approximately two months when compared to the previously published median TTP range of 1.4 to 2.7 months for patients who have failed Nexavar first-line therapy.
Other reported efficacy results include a median progression-free survival (PFS) of 3.7 months, and a median overall survival (OS) of 6.6 months, with 8 patients still continuing in the study.
The San Antonio, Texas-based company also released safety data that were in-line with previous reports.
"We see the safety and efficacy observations as strong validation of GenSpera's novel thapsigargin (TG) drug platform," analyst Swayampakula Ramakanth wrote in a research note to investors today.
As the first-in-class drug based on the TG platform, mipsagargin's reported disease control rate (DCR) of 65 percent and median TTP of 4.2 months both compare favourably to reported data from other HCC clinical studies. The reported median PFS and OS are also in-line with other studies, HCW said.
"We believe these encouraging results merit moving mipsagargin into Phase 3 clinical studies. Nexavar remains the only FDA approved treatment for advanced HCC, and patients who fail Nexavar therapy are left with no other options," Ramakanth said.
"The latest results have demonstrated mipsagargin's potential in filling this unmet medical need. We expect management to finalize the trial protocol and initiate a Phase 3 study in the US in 4Q15."
HCW also noted that GenSpera's management has also indicated that they are looking to secure partners to conduct clinical programs with mipsagargin in Asia, where HCC is highly prevalent.
GenSpera is expected to release the interim data from the mipsagargin Phase 2 study for the treatment of advanced glioblastoma multiforme in the third quarter. HCW said positive results from this study could serve as an additional validation of the TG drug platform as an effective treatment for advanced solid tumours.
Shares of GenSpera were up 7.8 percent at $0.825 at 2:56 p.m. in New York.
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