On October 17, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that a review of research conducted with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) has been accepted for publication by the prestigious medical journal, Advances in Therapy (Press release, Delcath Systems, OCT 17, 2016, View Source;p=RssLanding&cat=news&id=2212191 [SID1234515872]). The retrospective study, "Chemosaturation Percutaneous Hepatic Perfusion: A Systemic Review," was conducted by a team led by Dr. Arndt Vogel of the University of Hanover in Germany, and resulted from a CHEMOSAT Experts Forum convened by Delcath in February 2015.

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"This retrospective study originated as a white paper produced by our Experts Panel in 2015 as a means of sharing information, recent research results, and clinical experiences using CHEMOSAT to treat primary and metastatic liver cancers," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We are pleased that Dr. Vogel and his teams’ work has been accepted for publication in such a prestigious journal as Advances in Therapy, and that the potential for CHEMOSAT to treat primary and metastatic liver cancers as identified by our experts will reach a wider audience."

On October 31, 2016 RadioMedix Inc. and AREVA Med (now Orano Med) reported that they have been awarded a collaborative Small Business Innovation Research Contract by the National Institutes of Health, National Cancer Institute to evaluate targeted alpha-emitter therapy of neuroendocrine tumors (NETs) (Press release, RadioMedix, OCT 16, 2016, View Source [SID1234525018]). This is the fourth NIH funding awarded to RadioMedix during the last three years.

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Targeted Peptide Receptor Radionuclide Therapy (PRRT) of NETs is one of the main clinical focuses of RadioMedix, which has long been involved in several clinical studies as a co-sponsor or a collaborator. AREVA Med is focused on the production of lead-212 (212Pb), a rare metal used in TAT, and the development of therapeutics using this metal.

"We have established a very good collaboration with AREVA Med and we are very pleased that this work resulted in the SBIR Contract," said Izabela Tworowska PhD, Principal Investigator and RadioMedix Chief Science Officer." We have got promising preliminary results and we are confident that this contract will accelerate the development of Targeted Alpha Therapy (TAT) agents. I am grateful to NIH NCI agency for selecting this project for contract funding"

"AREVA Med is very excited about its collaboration with RadioMedix that will further support the growth of our pipeline of 212Pb-labeled agents, especially in NETs where we believe we can bring substantial additional efficacy compared to current treatment options" said Julien Torgue, PhD, AREVA Med Scientific Director.

"We are confident that we have secured all resources needed to accelerate translation of targeted alpha therapy agents to clinic," said Dr. Ebrahim Delpassand, CEO and Chairman of RadioMedix. "Our patients are anxiously waiting for this treatment, and we expect to launch a first in human clinical trial by the end of 2017."

Burzynski Research Institute has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On October 14, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto (venetoclax) for the treatment of people with chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor (Press release, Hoffmann-La Roche , OCT 14, 2016, View Source [SID:SID1234515807]). Venclyxto is also recommended for the treatment of people with CLL without 17p deletion or TP53 mutation who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor. Based on this positive CHMP recommendation, a final decision regarding the conditional marketing authorisation of Venclyxto is expected from the European Commission in the coming months. Venclyxto is being co-developed by AbbVie and Roche.

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"We are pleased that this positive CHMP opinion brings us closer to providing a much needed new treatment option to people in Europe with this difficult-to-treat disease," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "We look forward to continuing the development of this promising medicine in other blood cancers with our partner AbbVie."

Venclyxto is marketed as Venclexta in the United States. Venclexta received accelerated approval from the US Food and Drug Administration (FDA) in April of this year for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. Venclexta/Venclyxto is the first approved medicine designed to trigger a natural process that helps cells self-destruct, providing a new way to help people who received previous treatment for their CLL or who have a high-risk form of CLL.

About Chronic Lymphocytic Leukaemia (CLL)
CLL is the most common type of leukaemia in the Western world. CLL mainly affects men and the median age at diagnosis is about 70 years. Worldwide, the incidence of all leukaemias is estimated to be over 350,000 and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.
In certain cases of CLL, a part of chromosome 17 is lost and along with it an important gene that controls apoptosis (programmed cell death) called p53. The 17p deletion is found in 3 to 10 percent of previously untreated cases and up to 30 to 50 percent of relapsed or refractory cases.

About Venclexta/Venclyxto
Venclexta/Venclyxto is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in chronic lymphocytic leukaemia (CLL) has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct. Venclexta/Venclyxto is being co-developed by AbbVie and Roche. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being evaluated in Phase III clinical trials for the treatment of relapsed, refractory and previously untreated CLL, along with studies in several other cancers. Venclexta/Venclyxto is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

On October 13, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH), reported that preliminary safety and clinical activity results for the Phase I study testing IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas ("CTCL") will be presented by Professor Martine Bagot, Head of the Dermatology Department at the Saint-Louis Hospital, Paris, at the Third World Congress of Cutaneous Lymphomas "3WCCL" (October 26-28, 2016, in New-York, USA) (Press release, Innate Pharma, OCT 13, 2016, View Source [SID:SID1234515792]).

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The presentation will be made available on the Company’s website, in the Product Pipeline – IPH4102 section after the session.

About the presentation:

Title: "First-in-Human, open label, multicenter phase I study of IPH4102, first-in-class humanized anti-KIR3DL2 mAb, in relapsed/refractory CTCL: preliminary safety and clinical activity results"
Scientific Session O. Therapeutics 3a: Endpoints & Clinical Trials
Date: October 28, 2016
Presentaton Time: 13:30 – 14:45 EST
Presenter: Pr. Martine Bagot, Head of the Dermatology Department, Saint-Louis Hospital, Paris
Location: Roone Arledge Auditorium – Alfred Lerner Hall at Columbia University – New York
About IPH4102 Phase I trial:

The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands, and United Kingdom) and in the US (NCT02593045). Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), 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 levels. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D); the dose-escalation follows an accelerated 3+3 design;
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. Cohort design (CTCL subtype, number of patients…) may be revisited 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 repeated administrations of single agent IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity. A large set of exploratory analyses aims at identifying biomarkers of clinical activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.

About IPH4102 Phase I trial:

The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands, and United Kingdom) and in the US (NCT02593045). Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), 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 levels. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D); the dose-escalation follows an accelerated 3+3 design;
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. Cohort design (CTCL subtype, number of patients…) may be revisited 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 repeated administrations of single agent IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity. A large set of exploratory analyses aims at identifying biomarkers of clinical activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.