On July 11, 2018, as part of its business strategy to build a meaningful and differentiating presence in Global Oncology Therapy market, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) reported the roll-out of Gemcitabine InfuSMART in Europe (Press release, Sun Pharma, JUL 11, 2016, View Source [SID1234525572]). InfuSMART is a technology in which oncology products are developed in a Ready-To-Administer (RTA) bag. Until now, compounding of oncology products was done at compounding centres or compounded in hospital pharmacies, an extra step before the medicine can be administered to patients. With the roll-out of Gemcitabine InfuSMART, Sun Pharma becomes world’s first pharmaceutical company to manufacture and launch a licensed RTA oncology product. This innovatively differentiated product will have a shelf life of two years. Over the next few months, Sun Pharma will launch Gemcitabine InfuSMART across Netherlands, UK, Spain, Germany, Italy & France.

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Sun Pharma received regulatory approval to produce Gemcitabine InfuSMART in eight key SKUs. The InfuSMART concept involves dose banding practice whereby, through agreement between prescribers and pharmacists, standardized doses of intravenous cytotoxic drugs are used for ranges (or ‘bands’) of doses calculated for individual patients. More InfuSMART oncology products are currently in Sun Pharma’s pipeline to be rolled out in the future.

Commenting on the roll-out of InfuSMART in Europe, Ms Hellen de Kloet, Business Head – Western Europe & ANZ, Sun Pharma said, "Sun Pharma’s Gemcitabine InfuSMART ready-to-administer infusion products provide the combined advantage of long stable compounded medicine along with safety. Its ready availability for treatment can make a difference to the healthcare worker and patients. Traditionally such medicines are compounded at hospitals (in-house) or outsourced to compounding pharmacies making it a time-consuming and potentially hazardous process. Launch of InfuSMART will help us remain a meaningful player in the global oncology therapy market by offering differentiating cancer treatment solutions. We believe there are opportunities for us to expand our portfolio of ready-to-administer products across multiple therapies where time and safety are an important element of treatment."

The NHS (UK) has been encouraging development of licensed RTA products. It has issued guidelines for hospitals for procuring such medicines. The launch of Gemcitabine InfuSMART offers Sun Pharma a definite first-mover advantage in Europe for cancer treatment. The Gemcitabine InfuSMART RTA infusion bag is developed at Sun Pharma’s R&D centre in India.

According to WHO, cancer figures amongst the leading causes of morbidity and mortality worldwide, with approximately 14 million new cases and 8.2 million cancer related deaths in 2012. The number of new cases is expected to rise by about 70% over the next two decades. Among men, the five most common cancers diagnosed in 2012 were lung, prostate, colorectum, stomach, and liver cancer. Among women the five most common cancers diagnosed were breast, colorectum, lung, cervix and stomach.

On July 11, 2016 Celsion Corporation (NASDAQ:CLSN) reported that its ongoing Phase III OPTIMA trial evaluating ThermoDox in primary liver cancer, also known as hepatocellular carcinoma or HCC, was featured during an oral presentation at the 7th Asia-Pacific Primary Liver Cancer Expert (APPLE) Meeting (Press release, Celsion, JUL 11, 2016, View Source [SID:1234513809]). ThermoDox is the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of HCC.

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Soo-Young Park, M.D., Associate Professor, Kyungpook National University, School of Medicine Division of Gastroenterology and Hepatology, delivered the presentation, titled, "Radiofrequency Ablation +/- Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) in Intermediate-Size Hepatocellular Carcinoma: The Ongoing Phase III OPTIMA Study." The OPTIMA Study is an ongoing global, pivotal, double-blind, placebo-controlled clinical trial evaluating ThermoDox in combination with Radio Frequency Ablation (RFA) standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The study was developed in consultation with leading primary liver cancer, statistical and regulatory experts, and is based on extensive analysis of prior clinical and preclinical studies of ThermoDox plus standardized RFA.

"The OPTIMA study represents an important study in the field of HCC, one of the most common and deadly cancers worldwide," said Dr. Park. "ThermoDox plus standardized RFA has the potential to significantly improve overall survival of newly diagnosed patients, and I look forward to working with my colleagues to further advance this trial."

"Data from the earlier HEAT Study suggest that not only does this approach potentially prolong survival, but may also serve as a curative treatment for HCC," stated Won Young Tak, M.D., Professor, Kyungpook National University, School of Medicine, Division of Gastroenterology and Hepatology. "If positive, this study could potentially establish ThermoDox plus standardized RFA as a first-line treatment for HCC."

In July 2015, Celsion reported the latest overall survival (OS) analysis of the HEAT Study post hoc subgroup. The OS analysis demonstrated that in a large, well bounded, subgroup of patients (n=285 patients, 41% of the previous 701 patient HEAT Study), treatment with a combination of ThermoDox and standardized RFA (defined as RFA standardized to a minimum of 45 minutes or sRFA > 45 min) provided an average 58% improvement in OS compared to standardized 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. In this large subgroup, median OS for the ThermoDox plus standardized RFA group translates into a 25.4 month (more than 2.1 year) survival benefit over the standardized RFA only group – totaling approximately 80 months (6-1/2 years, which is considered a curative treatment for HCC) for the ThermoDox plus standardized RFA group versus 53.6 months for the standardized RFA only group.

"The strength of the preclinical and clinical data to date reinforces our confidence in the potential of ThermoDox in HCC and for a successful trial outcome," stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We are extremely encouraged with the investigators’ interest and enthusiasm for our approach. With the trial enrolling patients in 13 countries, and in 9 of up to 20 sites in the Peoples Republic of China, we remain focused on the efficient execution of the only active Phase III study in newly diagnosed HCC patients."

The OPTIMA Study

OPTIMA, a pivotal, double-blind, placebo-controlled Phase III clinical trial, is expected to enroll up to 550 patients at up to 75 sites in the North America, Europe, China and Asia Pacific. As of June 2016, the study has been successfully enrolling patients at more than 50 clinical sites in 13 different countries in North America, Europe and Asia Pacific. In December 2015, Celsion announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the OPTIMA Study at up to 20 additional clinical sites in China, the country where approximately 50% of the 850,000 new cases of primary liver cancer are diagnosed each year and where the Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.

The primary endpoint for the OPTIMA Study is overall survival (OS). The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC). The design of the OPTIMA Study is supported by the retrospective analysis of a large subgroup of 285 patients in the Company’s previous 701 patient HEAT Study in primary liver cancer. The study is also designed to establish a clear path to approval in major liver cancer markets worldwide, with results from the OPTIMA Study, if successful, providing the basis for a global registration filing and marketing approval.

About LTLD (ThermoDox)

Celsion’s most advanced program is a heat-mediated, tumor-targeting drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. In one of its most advanced applications, LTLD, when combined with radiofrequency thermal ablation (RFA), has the potential to address a range of cancers. For example, RFA in combination with ThermoDox has been shown to expand the "treatment zone" with a margin of highly concentrated chemotherapy when treating individual primary liver cancer lesions. The goal of this application is to significantly improve efficacy.

Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. The first: Rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, LTLD is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. The second: When an external heating device heats the tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that release the chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area related to tumor invasion, supporting precise drug targeting.

On July 11, 2016 Mylan N.V. (NASDAQ, TASE: MYL) reported the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is a generic version of Merck’s Temodar (Press release, Mylan, JUL 11, 2016, View Source [SID:1234513811]). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

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Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, had U.S. sales of approximately $176.5 million for the 12 months ending May 31, 2016, according to IMS Health.

Currently, Mylan has 246 ANDAs pending FDA approval representing $107.4 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

On July 11, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), in collaboration with researchers from the Institute of Cancer Research in London, reported positive results for EndoPredict, a second-generation prognostic gene expression test for breast cancer (Press release, Myriad Genetics, JUL 11, 2016, View Source [SID:1234513812]). The study achieved its primary endpoint by demonstrating that EndoPredict (EPclin) was superior to the first-generation Oncotype DX Breast Recurrence Score (RS) in predicting the long-term recurrence of ER+, HER2- primary breast cancer. The study was published in the Journal of the National Cancer Institute (JNCI).

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"This important study demonstrated that EndoPredict more accurately predicted the recurrence of breast cancer up to 10 years after diagnosis in patients with ER+, HER2- breast cancer than the other test studied," said Jack Cuzick, Ph.D., FRS, director of the Wolfson Institute of Preventive Medicine in London, and an investigator of the study. "These findings will help physicians identify patients who do not need adjuvant chemotherapy following surgery, resulting in a more personalized treatment for their patients."

The analysis included 928 women from the TransATAC study and compared the prognostic power of EndoPredict versus the first-generation test. The primary endpoint of the study was distant relapse-free survival. This analysis showed that EndoPredict markedly outperformed Oncotype DX across the 10-year follow-up period with prognostic power more than four times higher (EPclin: LRX2= 139.3; RS: LRX2=29.1). Using pre-defined cutoffs, EndoPredict and Oncotype DX identified 58.8 percent and 61.7 percent of patients as low risk with hazard ratios for low- versus non-low-risk of 5.9 and 2.7, respectively. Importantly, the authors noted that "EPclin’s superior ability to classify patients as low risk was further demonstrated by the similar number of patients classified as low risk by RS coupled with a substantially lower 10-year recurrence rate (5.8% for EPclin vs 10.1% for RS)."

"EndoPredict significantly outperformed the first-generation prognostic test in this head-to-head study, especially for late distant recurrences and in node-positive patients" said Ralf Kronenwett, M.D., chief scientific and medical officer, Sividon. "Additionally, EndoPredict did not classify any patients as intermediate risk, while Oncotype DX classified 28 percent of as intermediate risk which can be confusing for clinicians trying to make treatment decisions."

The JNCI publication can be accessed at: View Source

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About EndoPredict
EndoPredict is a next-generation, multigene prognostic test for patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in over 13,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety.

On July 11, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported that it has been granted a new European patent covering its investigational Phase 3 cancer immunotherapy drug Multikine* (Leucocyte Interleukin) (Press release, Cel-Sci, JUL 11, 2016, View Source [SID:1234513827]). The patent, EU Patent: EP 1 773 368 B1, titled "A Method Of Pre-Sensitizing Cancer Prior To Treatment With Radiation and/or Chemotherapy And A Novel Cytokine Mixture," is not limited to any one particular type of cancer and can include multiple types of cancer.

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This invention relates to a novel method for pre-sensitizing cancer cells prior to a therapeutic treatment such as chemotherapy or radiation therapy. This effect is created by CEL-SCI’s immunotherapy drug Multikine which, as part of its mode of action, induces cancerous cells to enter a proliferative cell cycle phase therapy, thereby potentially increasing their vulnerability to chemotherapy and radiation therapy.

Geert Kersten, Chief Executive Officer of CEL-SCI, said, "This European patent should protect one of the largest applications for Multikine, namely its use in combination with radiation and chemotherapy. Our ongoing Phase 3 clinical trial in head and neck cancer patients is administering Multikine therapy as part of a first-line treatment, before any other treatments and prior to surgery, followed by radiation or concurrent chemoradiotherapy."

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. The study is being conducted in 24 countries and has enrolled over 850 patients so far.

About Multikine

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.