On January 10, 2018 PTC Therapeutics presented at the 36th Annual J.P. Morgan Healthcare Conference (Presentation, PTC Therapeutics, JAN 10, 2018, View Source [SID1234523051]).

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On January 10, 2018 Intrexon Corporation presented Presentation, dated January 10, 2018 (Presentation, Intrexon, JAN 10, 2018, View Source [SID1234523050]).

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On January 10, 2018 RadioMedix Inc. and AREVA Med reported the initiation in the United States of Phase I trial for AlphaMedixTM in patients with somatostatin receptor positive neuroendocrine tumors (Press release, RadioMedix, JAN 10, 2018, View Source [SID1234525019]). AlphaMedixTM is composed of a somatostatin (SST) analogue radiolabeled with 212Pb, an isotope used for Targeted Alpha-emitter Therapy (TAT).

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"Targeted Alpha-emitter Therapy (TAT) is the wave of the future in nuclear oncology and has a tremendous potential to treat patients with NET and overcome some of the limitations of current Peptide Receptor Radionuclide Therapy (PRRT)" said Dr. Ebrahim S. Delpassand, Chairman and CEO of RadioMedix, sponsor of the trial.

"Building on compelling preclinical results, I trust that this study with the combination of our excellent research and clinical teams and AREVA Med’s expertise in 212Pb-labeled radiotherapeutics development, will mark an important milestone in TAT" added Dr. Izabela Tworowska, CSO of RadioMedix.

This open-label, dose escalation study’s objective is to determine safety, bio-distribution, and preliminary effectiveness of 212Pb-AR-RMX in adult patients with differentiated NETs. Patients will be enrolled at Excel Diagnostic and Nuclear Oncology Center (Houston, TX).

"Excel Diagnostics and Nuclear Oncology Center (EDNOC) was the first institution in the United States to conduct a clinical trial using Lu-177 DOTATATE PRRT, making this therapy available to NET patients. EDNOC in continuation of its tradition, will be the first center to pioneer TAT in the U.S." added Dr. Delpassand, Medical Director of EDNOC.

"AREVA Med has for many years been focused on setting up a reliable production of 212Pb and developing therapeutics using this promising isotope. Our collaboration with RadioMedix and this Phase 1 trial is an important accomplishment as we believe that 212Pb-based therapies will have a significant impact on difficult to treat tumors. In this context, AlphaMedixTM could prove to be particularly appropriate for patients suffering from NETs and go beyond limitations of existing treatments" said Julien Dodet, AREVA Med’s CEO.

On January 10, 2018 LIDDS reported that it has successfully completed another preclinical study in mice assessing the feasibility of using the NanoZolid drug delivery technology for intratumoral immunotherapy (Press release, Lidds, JAN 10, 2018, https://www.globenewswire.com/news-release/2018/01/10/1286736/0/en/LIDDS-NanoZolid-with-immune-stimulating-agent-confirms-efficacy-in-an-additional-cancer-model.html [SID1234555920]). Clear anti-tumor effects have been observed in another cancer model in mice where significant decreases in tumor growth was demonstrated.

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LIDDS has several projects ongoing that focus on assessing the feasibility of using the NanoZolid-technology for local or intratumoral immunotherapy. These studies aim at a local intratumoral delivery of an immune-stimulatory agent.

The confirmed anti-tumor effect of an immune-stimulating agent formulated using the NanoZolid-technology in two independent cancer models in mice, will trigger the initiation of follow-on studies. The possibility that local immune-stimulation using the NanoZolid-technology will increase the effects of systemic immunotherapy will be investigated. Results are expected during the next four months.

A locally delivered immunotherapy has the potential to act either as a monotherapy or in combination with systemic immunotherapies e.g. checkpoint inhibitors. Successful combination treatments could significantly increase the response rates and efficacy rates of current immunotherapies. As immuno-oncology is the fastest growing area in oncology, reaching a market size over 100 billion USD by 2022, these results should be of great interest to pharmaceutical companies seeking new combination modalities to increase the response rate and efficacy of their immunotherapy drugs.

A recent review article in the highly ranked journal Annals of Oncology highlights the unique opportunity of intratumoral treatments to increase the efficacy of immunotherapy while reducing the potential side-effects, View Source

Immunotherapy for the treatment of cancer aims to activate and utilize the body’s own immune system to recognize and attack tumors and cancer cells and is today the most promising area of cancer research.

On January 10, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that it has concluded a modification agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (The FOCUS Trial). The modification agreement revises the FOCUS trial’s eligibility criteria to permit a greater extent of extra-hepatic disease by removing the size restriction, number and location of extra-hepatic lesions, in conjunction with a treatment plan for the extra-hepatic metastases.

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Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, "We requested this protocol modification to improve patient access to this important clinical trial for appropriately selected and managed patients. In an ultra-orphan indication like ocular melanoma, striking the appropriate balance between eligibility criteria and patient access can be a challenge. We are pleased that the FDA agreed to this modification, and hope that once approved by the institutional review boards of our participating clinical trial sites, that this modification will help accelerate enrollment in this registrational trial."

PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.