On December 2, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that physicians in Europe have completed over 250 treatments with Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) since the second generation of CHEMOSAT was launched (Press release, Delcath Systems, DEC 2, 2015, View Source;p=RssLanding&cat=news&id=2119515 [SID:1234508381]). Physicians in Europe have used CHEMOSAT in both commercial and clinical settings to treat patients for a wide variety of cancers in the liver, including ocular melanoma liver metastases, hepatocellular carcinoma and intrahepatic cholangiocarcinoma, and liver metastases from colorectal cancer, breast cancer and others.

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Concurrently, Delcath announces the activation of the prestigious Harley Street Clinic (HSC) in London, United Kingdom as a CHEMOSAT treatment site. HSC is a specialist private hospital that provides complex cardiac, cancer and neurosciences care. HSC is supported by HCA International and owned by HCA Inc., the largest provider of private healthcare in the world. Julian Hague, M.D., an interventional radiologist with HSC, performed the clinic’s first CHEMOSAT treatment on a patient with breast cancer liver metastases in November.

"I believe the future of interventional oncology lies in tailoring the treatment to the individual patient," said Dr. Hague. "I believe having CHEMOSAT in our treatment armamentarium represents major progress in our ability to provide liver directed therapies to patients."

"The completion of our 250th CHEMOSAT treatment and the activation of the Harley Street Clinic highlight the steady progress our team has made in expanding the clinical adoption of this therapy," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "Over the past two years our team has built a strong commercial and clinical footprint for CHEMOSAT in Europe. We look forward to continuing to build on this momentum in the New Year in order to increase revenue and, importantly, to enhance the lives of patients suffering with these life-limiting conditions."

On December 02, 2015 Oncothyreon Inc. (Nasdaq:ONTY), a clinical-stage biopharmaceutical company dedicated to the development of therapeutic products that can improve the lives and outcomes of patients with cancer, reported that it will conduct a conference call on Tuesday, December 8, 2015 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific) to discuss new clinical data from ongoing clinical trials of ONT-380, an orally active, reversible and selective small-molecule HER2 inhibitor being developed for the treatment of metastatic breast cancer (Press release, Oncothyreon, DEC 2, 2015, View Source [SID:1234508382]). The data, which include additional and updated clinical trial data on ONT-380 for the treatment of patients with HER2-positive metastatic breast cancer, as well as an analysis of patients who suffer from central nervous system (CNS) metastases, are slated for presentation during the San Antonio Breast Cancer Symposium (SABCS) being held December 8-12, 2015 in San Antonio, TX.

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To participate in the call by telephone, please dial (877) 280-7291 (United States) or (707) 287-9361 (International). In addition, the call will be webcast live and can be accessed on the "Events" page of the "News & Events" section of Oncothyreon’s website at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on the Oncothyreon website.

On December 2, 2015 LifeMap Sciences, Inc. ("LifeMap"), a life sciences technology company and a subsidiary of BioTime, Inc., and MedGenome, Inc. ("MedGenome"), a genomics-based diagnostics and research company, reported a global collaboration agreement (Press release, BioTime, DEC 2, 2015, View Source;p=RssLanding&cat=news&id=2119546 [SID:1234508385]). The agreement will strengthen LifeMap’s next generation sequencing (NGS) analysis solutions in the oncology field by incorporating data from MedGenome’s OncoMD database for use by LifeMap clients. The Oncology NGS market is a significant growth driver within the multi-billion dollar global NGS market.

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LifeMap‘s NGS products facilitate and enhance biomedical research and healthcare outcomes. Powered by its comprehensive, proprietary GeneCards knowledgebase, LifeMap’s NGS analytics software can rapidly and cost-effectively identify genetic variants that impact disease management and health outcomes. The GeneCards knowledgebase is used by more than 3000 institutions in over 200 countries worldwide.

OncoMD is a comprehensive knowledge base of cancer specific somatic and germ line variations collected from peer-reviewed scientific publications. It enables users to easily identify mutation prevalence in multiple cancer types as well as sensitivity to approved therapies via linkage of mutations to approved drugs and open clinical trials.

"Integrating OncoMD into our NGS analysis products is another important milestone in our ongoing NGS solutions development initiatives," said David Warshawsky, Ph.D., President and Chief Executive Officer of LifeMap Sciences. "MedGenome’s OncoMD provides the latest scientific evidence and drug information to enable identification of driver mutations and the impact of targeted, personalized drugs in the oncology area; elements of significant interest to our current and future clients in the oncology arena."

"We are happy to partner with LifeMap Sciences and to offer its users our unique annotations on cancer variants," said Dr Kartik Kumaramangalam, Chief of Global Products & Services at MedGenome. "This is in line with our commitment to develop products and solutions that enable oncologists and researchers to gather insights into the genetics of cancers."

On December 2, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that a first patient has been dosed in the Phase I clinical trial of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (Press release, Innate Pharma, DEC 2, 2015, View Source [SID:1234508386]). IPH4102 is a first-in-class cytotoxic antibody against KIR3DL2, a tumor marker specifically expressed in most subtypes of CTCL. It has an orphan drug designation in the European Union for the treatment of CTCL.

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Pierre Dodion, Chief Medical Officer of Innate Pharma, said: "We are proud of and enthused by this major milestone for IPH4102, a program that was fully developed in house. The program has benefited from constant collaboration with Saint-Louis Hospital (Paris, France), and especially with Pr. Martine Bagot, Head of the Dermatology Department and co-discoverer with Pr. Armand Bensussan of the target KIR3DL2. Now, with the involvement of additional international expert centers in Europe and the USA, we believe that we are in optimal conditions to bring this exciting drug to patients with a high unmet medical need".

Hervé Brailly, CEO and co-founder of Innate Pharma, added: "From a strategic point of view, IPH4102 is an important addition to and diversification of our pipeline: it is our first cytotoxic antibody, aiming at depleting KIR3DL2 expressing cells. Developing it in a targeted patient population with an associated biomarker points to a very straightforward path to potentially reach regulatory approval. This prompts our interest in keeping the full rights to develop this drug and eventually market it on our own".

This Phase I trial comprises a dose escalation and a cohort expansion, which are expected to deliver data at the end of 2017 and 2018 respectively. The program was presented in New York during a Key Opinion Leader event chaired by Pr. Youn H. Kim, MD, Professor of Dermatology, Director of the Multidisciplinary Cutaneous Lymphoma Program and Medical Director of the Photopheresis Service at the Stanford Medical Center, as well as in Paris during a Key Opinion Leader event chaired by Pr. Martine Bagot. The presentations are available on Innate Pharma’s website.

About IPH4102 Phase I trial:

The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas which is performed in Europe (France, Netherlands, United Kingdom) and in the US. Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the MD Anderson Cancer Center (Houston, Texas), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the Leiden University Medical Center (Netherlands), and the Guy’s and St Thomas’ Hospital (United Kingdom). Approximately 60 patients with KIR3DL2-positive CTCL having received at least two prior lines of systemic therapy are expected to be enrolled in two sequential study parts:

A dose-escalation part including approximately 40 CTCL patients in 10 dose cohorts. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D);

A cohort expansion part with 2 cohorts of 10 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) receiving IPH4102 at the RP2D until progression. The CTCL subtypes may be adjusted based on the findings in the dose escalation part of the study.

The primary objective of this trial is to evaluate the safety and tolerability of IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity and identification of biomarkers of this activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.

On December 1, 2015 Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) reported that data for VYXEOS (formerly CPX-351), its lead product candidate, will be presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, December 5-8, 2015 (Press release, Celator Pharmaceuticals, DEC 1, 2015, View Source [SID:1234508370]).

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Abstracts selected for poster presentation are:

Date: Sunday, December 6, 2015, 6:00 p.m. – 8:00 p.m.
Presentation Title: CPX-351 ((Cytarabine:Daunorubicin) Liposome Injection, (Vyxeos)) Does Not Prolong QTcF Intervals, Requires No Dose Adjustment for Impaired Renal Function and Induces High Rates of Complete Remission in Acute Myeloid Leukemia
Presenter: Dr. Tara Lin
Abstract Number: 2510
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II
Location: Hall A (Orange County Convention Center)

Date: Monday, December 7, 2015, 6:00 p.m. – 8:00 p.m.
Presentation Title: CPX-351 Enables Administration of Consolidation Treatment in the Outpatient Setting and Increases the Time Spent out of the Hospital after Completion of AML Treatment Compared with 7+3
Presenter: Dr. Jeffrey Lancet
Abstract Number: 4507
Session: 902. Health Services and Outcomes Research – Malignant Diseases: Poster III
Location: Hall A (Orange County Convention Center)