On September 9, 2015 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported new biomarker and updated clinical data for the company’s Phase 2 anti-Notch2/3 therapeutic candidate, tarextumab (OMP-59R5) (Press release, OncoMed, SEP 9, 2015, View Source [SID:1234507431]). These data show the potential of Notch3 overexpression as a prognostic factor in small cell lung cancer and update OncoMed’s Phase 1b results for tarextumab in combination with standard-of-care chemotherapy for the first-line treatment of patients with extensive-stage disease. Anne Chiang, M.D., Ph.D., of the Yale School of Medicine, will present these data in a mini-oral presentation this afternoon at the 16th World Lung Conference on Lung Cancer.

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"Notch is known to be a fundamental cancer stem cell pathway driving the initiation and spread of tumors. Notch3 in particular has been associated with poor prognosis in a variety of solid tumor types, including pancreatic, breast and ovarian cancers," said Dr. Chiang. "Our analyses of small cell lung cancer patient tumors demonstrate that Notch3 overexpression in extensive-stage small cell lung cancer tumors is common and may be associated with poor survival. This is the first time that Notch3 tumor expression has been tested in small cell lung cancer and associated with poor patient outcomes."

A retrospective tumor microarray analysis that looked at Notch3 overexpression in 31 small cell lung cancer samples with available follow-up survival data showed that high levels of Notch3 protein expression appears to correlate with worse survival outcomes in patients with extensive-stage small cell lung cancer, elucidating for the first time that Notch3 may be an important prognostic factor in this solid tumor indication. Based on this analysis, prevalence of Notch3 overexpression in small cell lung cancer was estimated at 64 percent. This prevalence data is consistent with previously reported OncoMed biomarker data in small cell lung cancer.

"These new prognostic and prevalence observations for Notch3 provide a biological rationale for utilizing OncoMed’s anti-Notch 2/3 targeting antibody, tarextumab, in the small cell lung cancer indication," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "In the clinic, we are seeing a consistent association between tarextumab dose and efficacy in our Phase 1b small cell lung cancer study. We’ve observed promising tumor response, biomarker and survival results among those small cell lung cancer patients who received doses of tarextumab above 10 mg/kg every three weeks. In a small number of patients, we are seeing that patients with Notch3 overexpressing tumors – where we might anticipate the worst outcomes – have the best survival rates, suggesting on-target activity. These data give us greater confidence that the 15 mg/kg every three week dose of tarextumab and the endpoints evaluating both all comer and tumor Notch3 high patient populations in our ongoing Phase 2 PINNACLE study are the right ones."

Overall survival data presented today from OncoMed’s Phase 1b study of tarextumab in combination with etoposide and platinum therapy for 23 patients with previously untreated extensive-stage small cell lung cancer show a correlation between dose and efficacy. Patients who received higher doses ( > 10 mg/kg) of tarextumab every three weeks plus chemotherapy demonstrated improved overall survival compared those who received lower doses. This durability of response was observed regardless of Notch3 gene expression status. Patients whose tumors tested biomarker positive for Notch3 expression and received higher doses of tarextumab with chemotherapy achieved the most benefit and a median overall survival for these patients has not yet been reached. These data expand on the findings of a dose-dependent relationship between tumor responses and survival among patients whose tumors were high in Notch3 expression that were reported at the 2015 ASCO (Free ASCO Whitepaper) Annual Meeting in June.

About the Phase 2 PINNACLE Trial

OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab (anti-Notch 2/3, OMP-59R5) for the treatment of small cell lung cancer. The randomized Phase 2 trial will compare progression-free survival (PFS) outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive chemotherapy alone. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.

About Small Cell Lung Cancer

According to the American Cancer Society, lung cancer (both small cell and non-small cell) is the second most common cancer in men and women and is by far the leading cause of cancer death. Small cell lung cancer is expected to make up about 10%-15% of the 221,200 newly diagnosed lung cancer cases and the 158,040 deaths estimated to occur in the U.S. in 20151. SCLC tends to grow and spread quickly, and is typically not discovered until it has metastasized to other parts of the body (extensive stage). The current standard of care in treating small cell lung cancer is the chemotherapeutic etoposide in combination with either cisplatin or caboplatin. In spite of a high sensitivity to chemotherapy and remission rates of up to 80% following initial treatment, the median overall survival is six-twelve months for patients with extensive stage disease2.

About Tarextumab (anti-Notch2/3, OMP-59R5)

Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is currently being studied in two randomized Phase 2 clinical trials. The "ALPINE" study (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) is assessing tarextumab with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients. The "PINNACLE" study (A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer) is testing tarextumab in combination with etoposide and cisplatin and etoposide and carboplatin in first-line extensive-stage small cell lung cancer patients. Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.

On September 9, 2015 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported recent advancements in the field of electroporation (EP) and the future of catheter-based devices to perform minimally invasive intratumoral immunotherapy treatment at the First World Congress on Electroporation and Pulsed Electric Fields in Biology, Medicine and Food & Environmental Technologies in Portoroz, Slovenia (Press release, OncoSec Medical, SEP 9, 2015, View Source [SID:1234507432]).

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In a keynote presentation entitled: "Advances in Clinical Electroporation: Tissue Sensing, Feedback Control, and Catheter Technology," Robert H. Pierce, MD, Chief Scientific Officer, discussed OncoSec’s advances in intratumoral gene electro-transfer, using ‘smart’ tissue-sensing technology and the development of catheter-based electrodes, enabling treatment of deep and visceral tumors.

"We are excited to be presenting our engineering advances at the First World Congress," said Dr. Pierce. "The development of minimally-invasive electroporation devices capable of high-efficiency delivery of immunotherapeutic genes into tumors located anywhere in the body is critical to establishing intratumoral EP-mediated gene therapy as a standard therapeutic modality in immuno-oncology."

OncoSec’s New Catheter Electrode Technology

OncoSec’s new catheter-based electrodes are designed to be compatible with standard medical instrumentation, allowing access to deep and visceral tumors, where they are capable of anchoring to and treating the tumor using OncoSec’s proprietary technology. These all-in-one devices have the ability to inject a DNA-based agent, while deploying electrodes to perform electroporation in a single procedure. Moreover, these devices have an adjustable needle and electrode penetration depth allowing clinicians to treat tumors of varying dimensions to perform minimally invasive intratumoral immunotherapy.

Development of Tissue Sensing and Feedback Control

OncoSec is developing ‘smart’ electroporation technology capable of tissue sensing and real-time feedback control of electroporation pulse trains in order to attain optimal gene transfer and minimal electroporation-mediated tissue damage. Dr. Pierce added: "Taken together, these engineering advances can enable access and high-efficiency gene delivery to tumors throughout the body. This is key as we move forward in developing OncoSec’s pipeline of novel intratumoral therapies."

"Our partnership with Rev.1 Engineering and internal bioengineering expertise have allowed OncoSec to enhance our ImmunoPulse platform and position the Company as a leader in gene electro-transfer technologies in cancer immunotherapy," said Punit Dhillon, President and CEO of OncoSec. "We are also strengthening our intellectual property portfolio in the area of gene and drug delivery via electroporation to reach visceral tumors and enhance the uptake of therapeutic agents."

Licensing of University of South Florida Catheter Electrode Patent

OncoSec secured an exclusive license for a specific patented technology from the University of South Florida Research Foundation (USFRF). The patent provides a device and related methods to deliver molecules to cells that comprise any tissue. The patent includes a catheter-based electrode and methods to deliver molecules to cardiac tissue, blood vessels, other tissues/organs that can be accessed through a luminal tissue and luminal tissues. The device also functions as a non-catheter based electrode for performing the same functions. Financial terms of this agreement were not disclosed.

For more information about OncoSec and its technologies, please visit: www.oncosec.com.

On September 9, 2015 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body’s immune system to fight cancer, reported financial results for the first quarter of fiscal year (FY) 2016 ended July 31, 2015, and provided an update on its advancing clinical pipeline and other corporate developments (Press release, Peregrine Pharmaceuticals, SEP 9, 2015, View Source [SID:1234507437]).

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Highlights Since April 30, 2015:
"Over the years, Peregrine’s foundational science and positive clinical results have consistently pointed to bavituximab’s potential as a high-value, next-generation anti-cancer agent," said Steven W. King, president and chief executive officer of Peregrine. "In the last three months, these achievements have compelled others to align with us as we continue to develop bavituximab. In May, Peregrine announced an exciting collaboration with Memorial Sloan Kettering Cancer Center to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. Only three months later, we announced a collaboration with AstraZeneca to clinically evaluate bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736) in multiple solid tumors. These collaborations with world leaders in immuno-oncology speak to the promise of bavituximab and validate our ever-growing enthusiasm for the investigational product. We look forward to advancing both of these programs and completing enrollment of our SUNRISE trial in the next few months."

Clinical Development Highlights
Peregrine and AstraZeneca entered into a cancer immunotherapy clinical trial collaboration to evaluate bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid tumors. Peregrine is working closely with AstraZeneca to finalize the trial design.

Phase III SUNRISE clinical trial in non-small cell lung cancer (NSCLC) continues to enroll patients and remains on track to complete patient enrollment by end of calendar year 2015.

Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II trial to evaluate the combination of bavituximab and Opdivo (nivolumab), an anti-PD-1 antibody, in previously treated, metastatic NSCLC. This trial is expected to be initiated by the end of calendar year 2015.

Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is expected to be initiated by the end of calendar year 2015.

Supportive Research Highlights
Peregrine and Memorial Sloan Kettering Cancer Center entered into a research agreement to explore the potential of Peregrine’s proprietary PS-targeting antibody platform. The goal of the research is to identify effective treatments combining bavituximab with other checkpoint inhibitors or immune stimulating agents.

New data presented at the International Association for the Study of Lung Cancer’s (IASLC’s) World Conference on Lung Cancer (WCLC) from a translational study of bavituximab demonstrated the ability of bavituximab, alone or in combination with docetaxel, to induce signs of immune activation in non-small cell lung cancer (NSCLC) patient-derived tumor samples, particularly when there was negative PD-L1 expression in the tumor sample. These data further support the potential mechanistic synergies for bavituximab with chemotherapy and checkpoint inhibitors targeting the PD-1/PD-L1 pathway.

Summary data presented at the Combination Immunotherapy Strategies session at the 10th Annual Immunotherapy and Vaccine Summit (ImVacS), highlighted key findings from several recent bavituximab-focused studies including: the potential of bavituximab to shift the tumor microenvironment from immuno-suppressive in which tumors evade immune detection to a state of immune activation in which the immune system recognizes and fights the tumor; bavituximab’s potential to increase the number of activated CD8+ cells in the tumor, which stimulates PD-1 expression, potentially increasing the number of patients able to respond to PD-1 and PD-L1 targeting immunotherapies; and, results from several clinical and preclinical studies in a range of tumor types showing that bavituximab and bavituximab-like antibodies, in combination with conventional therapy, have consistently demonstrated estimated survival curves that plateau.

Data from preclinical studies presented at the 2015 ASCO (Free ASCO Whitepaper) annual meeting demonstrated the ability of the company’s PS-targeting antibodies to significantly increase the prevalence of tumor infiltrating CD8+ T-cells and immune-activating cytokines, while decreasing tumor-promoting macrophages and myeloid cells. These findings highlight the ability of the antibodies to enhance the anti-tumor effects of both chemotherapy and immune checkpoint inhibitors.

Avid Bioservices Highlights
Avid’s new manufacturing suite is fully constructed and the first internal pilot run is currently underway to verify all systems and equipment are properly functioning. Company plans to announce the launch of the new facility in the near term, allowing us to meet our internal manufacturing timelines as well as those of our third-party clients.

Contract manufacturing committed backlog reached $42 million from existing customers covering services to be completed in FY 2016 and into FY 2017.

Corporate Highlights
The European Patent Office (EPO) granted Patent Number 2,269,656, licensed to Peregrine titled "Selected Antibodies Binding to Aminophospholipids and their Use in Treatment, Such as Cancer." The patent covers bavituximab as a composition of matter and for use in therapy, such as for treating cancer including in combination with radiotherapy or chemotherapy, e.g., with docetaxel. This important patent expands upon the company’s intellectual property portfolio, which now numbers more than 140 worldwide issued patents and pending applications for the bavituximab oncology program.

Financial Results
Total revenues for the first quarter of FY 2016 were $9,671,000, compared to $5,496,000 for the same quarter of the prior fiscal year. The increase was primarily attributed to an increase in contract manufacturing revenue generated from Avid Bioservices.
Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services provided to its third-party clients for the first quarter FY 2016 were $9,379,000, compared to $5,496,000 for the same quarter of the prior fiscal year. Peregrine expects third-party contract manufacturing revenue for FY 2016 to be between $30 and $35 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical and potential commercialization of bavituximab.

Total costs and expenses in the first quarter of FY 2016 were $23,425,000, compared to $18,667,000 in the first quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the SUNRISE Phase III trial and increases in the cost of contract manufacturing associated with higher reported revenue. For the first quarter of FY 2016, research and development expenses were $13,918,000, compared to $10,201,000 for the first quarter of FY 2015. For the first quarter of FY 2016, cost of contract manufacturing was $4,608,000, compared to $3,583,000 for the first quarter of FY 2015.

Peregrine’s consolidated net loss attributable to common stockholders was $15,101,000, or $0.08 per share, for the first quarter of FY 2016, compared to a net loss attributable to common stockholders of $14,157,000, or $0.08 per share, for the same prior year quarter.

Peregrine reported $59,016,000 in cash and cash equivalents as of July 31, 2015 compared to $68,001,000 at fiscal year ended April 30, 2015.

More detailed financial information and analysis may be found in Peregrine’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

On September 08, 2015 ArQule, Inc. (Nasdaq:ARQL) reported that additional analyses of plasma biomarkers support the prognostic and predictive role of MET status in this previously reported phase 2 trial in hepatocellular carcinoma (HCC) (Press release, ArQule, SEP 8, 2015, View Source [SID:1234507413]). The data was presented at the International Liver Cancer Association (ILCA) 9th Annual Conference on September 6th, 2015.

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The phase 2 study, completed in the third quarter of 2011 and published in The Lancet Oncology medical journal in November 2012, enrolled 107 HCC patients who progressed or were intolerant to one prior systemic therapy. Multiple biomarkers were evaluated as part of the study, and MET status as determined by immunohistochemistry emerged as the strongest predictor of tivantinib benefit. In addition, the presentation noted that biopsies were more likely to be categorized as MET-high when taken after sorafenib therapy than before therapy. The presentation can be accessed in the "Investor and Media" section of our website, www.arqule.com, under "Recent Data Presentations."

"The biomarker data from this trial demonstrates that patients with MET-high tumors are more likely to benefit from tivantinib therapy," said Dr. Brian Schwartz, head of research and development at ArQule. "On the basis of the results from the phase 2 trial and in partnership with Daiichi Sankyo, we are conducting the pivotal phase 3 METIV-HCC trial that is enrolling MET-high HCC patients as determined by a required companion diagnostic test."

By the end of 2015 the pivotal phase 3 trial, METIV-HCC, is expected to complete enrollment of approximately 300 patients, randomized 2:1 treatment to best supportive care, with the primary end-point of overall survival.

About hepatocellular carcinoma (HCC)

Globally, liver cancer is the sixth most common cancer according to the World Cancer Research Fund International (782,000 new cases in 2012) and is the second cause of cancer related death (746,000 deaths in 2012). HCC accounts for about 90 percent of primary liver cancers. Cirrhosis, chronic hepatitis B and C and smoking are recognized worldwide as factors increasing the risk of HCC.

About MET and tivantinib (ARQ 197)

Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase, which is currently in Phase 2 and Phase 3 clinical trials. In healthy adult cells, MET can be present in normal levels to support natural cellular function, but in cancer cells, MET can be inappropriately and continuously activated. When abnormally activated, MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The activation of certain cell signaling pathways, including MET, has also been associated with the development of resistance to anti-EGFR (epidermal growth factor receptor) antibodies such as cetuximab and panitumumab.

Pre-clinical data have demonstrated that tivantinib inhibits MET activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in the tumors studied. Tivantinib has not yet been approved for any indication in any country.

In December 2008, ArQule and Daiichi Sankyo signed a license, co-development and co-commercialization agreement for tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.

On September 8, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported highlights from presentations by three leading experts in the treatment of intermediate primary liver cancer, also known as hepatocellular carcinoma (HCC) and Celsion’s pivotal Phase III OPTIMA Study of ThermoDox, the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with optimized radiofrequency ablation (RFA) (Press release, Celsion, SEP 8, 2015, View Source [SID:1234507414]). The symposium, entitled "Intermediate HCC: Cure vs. Palliation," was held on September 5, 2015 at the International Liver Cancer Association (ILCA) 9th Annual Conference in Paris, France and was moderated by Professor Riccardo Lencioni, MD, FSIR, EBIR, Executive Committee member of the ILCA Governing Board.

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The three presentations included:

"Current Management of Intermediate HCC: Unmet Medical Needs," by Ronnie T.P. Poon, MD, MBBS, MS, PhD, FRCS (Edin), FACS, Medical Director at the Hong Kong Integrated Oncology Center, Honorary Professor of Surgery at the University of Hong Kong Queen Mary Hospital, and member of the ILCA Governing Board. Dr. Poon discussed strategies for treating different stages of HCC including intermediate stage HCC which has been previously thought to be incurable. New treatment strategies, most notably an optimized RFA procedure with the investigational drug, ThermoDox, show clear promise as a potential cure for intermediate HCC in the years ahead.

"Intermediate HCC Treatment Paradigms and Lessons Learned," by Ghassan K. Abou-Alfa, MD, Professor at Memorial Sloan Kettering Cancer Center. Dr. Abou-Alfa reviewed results from recent clinical studies in intermediate stage primary liver cancer patients, including recent data from Celsion’s latest HEAT Study post-hoc analysis which suggests an overall survival benefit of more than two years in the large subgroup of patients treated with ThermoDox plus optimized RFA (RFA ≥ 45 minutes).

"OPTIMA Phase III Clinical Trial: Study Design and Protocols," by Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Pisa, Italy, Lead European Principal Investigator for Celsion’s HEAT Study and member of the ILCA Governing Board. Dr. Lencioni reviewed the latest findings from the HEAT Study post-hoc analysis, which strongly supports the rationale for a minimum 45 minute ablation time when using ThermoDox and suggests that there could be an important curative role for optimized RFA and ThermoDox in intermediate HCC. Celsion is currently evaluating ThermoDox plus optimized RFA in its ongoing Phase III OPTIMA Study, currently enrolling patients in over 75 clinical sites globally.

"Results from the HEAT Study, one of the largest clinical trials ever conducted in primary liver cancer, reinforce the potential for ThermoDox in combination with an optimized RFA regimen as a curative treatment for this deadly cancer," said Professor Lencioni. "With median overall survival of more than 6.5 years, or 79 months, data from the HEAT Study post-hoc analysis suggest a greater than two year median survival advantage for treatment with ThermoDox plus optimized RFA, a meaningful finding given that few treatments are effective in prolonging survival in HCC."

As of July 15, 2015, data from the latest HEAT Study post-hoc overall survival analysis demonstrated that in a large, well bounded subgroup of patients (n=285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox and optimized RFA provided an average 58% improvement in overall survival compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis was 0.63 (95% CI 0.43 – 0.93) with a p-value of 0.0198. Median overall survival for the ThermoDox group has been reached, which translates into a 2.1 year survival benefit over the optimized RFA group (79 months for the ThermoDox plus optimized RFA group versus 53.6 months for the optimized RFA only group).

The presentations are available on Celsion’s website at View Source

About The International Liver Cancer Association

The International Liver Cancer Association (ILCA) is the only international organization devoted exclusively to liver cancer research for experts from all related disciplines – medical, interventional and surgical oncology as well as hepatology. ILCA aspires to advance research in the pathogenesis, prevention and treatment of liver cancer.

About Celsion’s Phase III OPTIMA Study

Celsion’s Phase III OPTIMA Study is a global pivotal, double-blind, placebo-controlled study evaluating ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with optimized radiofrequency ablation (RFA) in HCC. The study is expected to enroll up to 550 patients in over 75 clinical sites in the North America, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for the trial is overall survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan for the OPTIMA Study calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).