On July 12, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that the European Society for Medical Oncology’s Scientific Committee has accepted an abstract for a poster presentation detailing the use of PV-10 as a treatment for stage III and IV melanoma as part of ESMO (Free ESMO Whitepaper)’s 2016 Congress (Press release, Provectus Pharmaceuticals, JUL 12, 2016, View Source [SID:1234513829]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The exact date and time of the presentation, titled "Intralesional Rose Bengal for Stage III and IV Melanoma," has yet to be decided. When the schedule is set, the details for this abstract, #3438, will be available at View Source

In addition, the abstract will also be published in the ESMO (Free ESMO Whitepaper) 2016 Congress Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology. ESMO (Free ESMO Whitepaper) has not yet announced the final publication number. The ESMO (Free ESMO Whitepaper) 2016 Congress will be held in Copenhagen, Denmark, from October 7-11, 2016.

On July 12, 2016 Amgen (NASDAQ:AMGN) reported that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee (Press release, Amgen, JUL 12, 2016, View Source;p=RssLanding&cat=news&id=2184704 [SID:1234513830]). ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During the meeting, Amgen will present a comprehensive data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical comparability to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.

"As a developer of innovative medicines and biosimilars, Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Today, we’re looking forward to discussing the efficacy, safety and immunogenicity profile of ABP 501, Amgen’s first prospective biosimilar, with the FDA advisory committee. If approved, ABP 501 has the potential to provide an additional treatment option for patients with chronic inflammatory diseases, as well as play a key role in long-term disease management."

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.

About ABP 501

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

On July 12, 2016 ONCODESIGN (ALONC – FR0011766229), a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, reported the official launch of a clinical study focusing on the evaluation of its first radiotracer in humans, as part of the IMAkinib project conducted jointly with Cyclopharma and the study sponsor, the Cancer Centre Georges-François Leclerc (CGFL) in Dijon (Press release, Oncodesign, JUL 12, 2016, View Source [SID:1234513845]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The objective of this radiotracer (ODS2004436) is to measure increased EGFR1 kinase activity during the development of a tumour, to select the treatment best suited to individual patients and to detect the emergence of any resistance early on. The radiotracer will be visualised by PET (Positron Emission Tomography), a standard nuclear imaging technique used for clinical diagnosis.

Mutations activating EGFR kinase are responsible for non-small cell lung adenocarcinoma, which accounts for 10 to 15% of lung cancers and affects 6,000 patients each year in France alone.

The clinical study, authorised by the French National Agency for Medicines and Health Products ANSM, is now ready to begin at the CGFL Cancer Centre, which has been granted the CLIP designation2 to conduct early-stage clinical trials. The first patient with lung cancer will be recruited within the next few weeks in the medical oncology department of the CGFL Cancer Centre in Dijon (Dr. Isambert, Head of the early-stage unit).

The objective of this phase 0/1 is to demonstrate the sensitivity and specificity of the radiotracer in human lung tumours. The clinical study will include 3 successive stages, designed to verify the specific labelling of tumours expressing the mutated EGFR receptor, verify the absence of significant marking on non-mutated tumours, and finally confirm the findings in a larger number of patients.

"With the advent of targeted therapies and precision medicine, the development of new molecular imaging biomarkers has become essential to provide the best treatment for patients," comments Prof. Fumoleau, Director of the CGFL Centre. "As a founding member of the Pharmimage platform with Oncodesign, it was only natural that we should conduct this phase 0/1 clinical study on the first radiotracer generated by the IMAkinib programme."

"This radiotracer was generated using our Nanocyclix technology, a chemical platform of next generation kinase inhibitors. The specificity of our molecules is a key advantage for the development of therapeutic molecules as well as for associated biomarkers, in a context of precision medicine and personalised treatments," adds Jan Hoflack, PhD, CSO of Oncodesign. "Our approach, which combines research on new therapies and identification of high-precision imaging tracers as of the first stage of our discovery programmes, is unique."

"Reaching the clinical stage in the development of an internal program for the first time is crucial for Oncodesign and its teams. It marks the culmination of 20 years of work and commitment to Oncodesign’s mission, i.e. provide patients with new cancer treatments," concludes Philippe Genne, PhD, founder and CEO of Oncodesign. "The IMAkinib project launched in 2009 includes several radiotracer programmes, the most advanced being the development of the radiotracer targeting the activated EGFR receptor. Our role in this programme is that of a pioneer in pharmaco-imaging focusing on new molecular markers. As this approach may lead to more effective treatments of tumours expressing EGFR-activating mutations using specific kinase inhibitors, it is important to identify such mutations."

About IMAkinib

IMAkinib is an Oncodesign research programme, conducted jointly with Cyclopharma and Ariana Pharmaceuticals. This programme received a grant from Bpifrance of €10.3m as part of the Industrial Strategic Innovation Programme, with an overall funding of €25m. The objective of IMAkinib is to develop biomarkers used in nuclear medicine to provide diagnostic solutions in oncology and help select the treatment best suited to individual patients, then monitor its efficacy and any potential resistance. The radiotracers developed are small molecules generated by Oncodesign’s Nanocyclix technology, labelled with radioactive 18F-fluorine [18F]. The IMAkinib programme includes several independent projects, the most advanced entering its phase 0/1 clinical study in lung cancer. Oncodesign has also worked jointly with Guerbet, and the teams of Prof. Denis Guilloteau of University François Rabelais in Tours and Dr Louisa Barré of CEA-Cycéron in Caen, on the development of radiochemical synthesis and on the preclinical studies on the radiotracer targeting the EGFR receptor.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.