1stOncology™: Cancer Intelligence Service – Page 15115 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Polaris Group’s ADI‑PEG 20 Shows Promising Clinical Activity in NSCLC When Combined with Standard First Line Chemotherapy Regimen

On January 10, 2018 Polaris Group reported that the combination of its lead therapeutic ADI‑PEG 20 (pegylated arginine deiminase) with the standard first-line chemotherapy cisplatin + pemetrexed doublet (PemCis) has shown promising clinical activity in an ongoing phase 1 study cohort of non-squamous non-small cell lung carcinoma (NSCLC) patients (Press release, Polaris Pharmaceuticals, JAN 10, 2018, View Source [SID1234526281]). The results will be presented by Dr. Peter Szlosarek from Barts Cancer Institute, London, at the fifth AACR (Free AACR Whitepaper)-IASLC International Joint Conference in San Diego.

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!

Twenty-one chemo-naïve NSCLC patients were enrolled in the single-arm, open label study to assess the safety and preliminary activity of ADI+PemCis. The treatment was well tolerated, and demonstrated robust tumor responses. Ten patients (47.6%) had a partial response, and 8 patients (38.1%) had stable disease for a disease control rate of 85.7%.

"We are excited to see that ADI+ PemCis demonstrated robust anti-tumor activity in the chemo-naïve NSCLC patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "There have been many exciting developments for NSCLC treatment in the past few years, especially in the area of immunooncology. We are planning new clinical studies that would combine ADI‑PEG 20 with standard chemotherapy as well as immunooncology therapy to maximize treatment effect for cancer patients."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

RADIOMEDIX AND AREVA MED ANNOUNCE INITIATION OF PHASE 1 CLINICAL TRIAL OF ALPHAMEDIX(TM), A TARGETED ALPHA THERAPY FOR PATIENTS WITH NEUROENDOCRINE TUMORS

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).

"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.

Genoscience Pharma to present data at ASCO-GI_18th-20th January, San Francisco, CA-USA

Abstract #202913

Clinical significance of high expression of a specific solute carrier transporter in HCC (Abstracts, GenoScience, JAN 10, 2018, View Source [SID1234523060]).

Patricia Gifu, Sonia Brun, Guanxiong Wang, Firas Bassissi, Claude Caron de Fromentel, Philippe Merle, Philippe Halfon; Cancer Research Center of Lyon, Lyon, France; Genoscience Pharma, Marseille, France; Service d’Hepatogastroentérologie, Hôpital de la Croix Rousse, Lyon, France

Background: Hepatocellular carcinoma (HCC) is the third cause of cancer-related death. GNS561 (Genoscience Pharma, France) is a small molecule inducing apoptosis by lysosome inhibition and caspase activation. GNS561 has high hepatotropism and anti-tumorigenic capacity on tumor bulk and cancer stem cells. Its main target is a specific solute carrier transporter (SLCt). We describe here the clinical relevance of the overexpression of SLCt in HCC patients.

Methods: The expression of SLCt was investigated by iQRT-PCR in surgically resected HCC tumors (T) and the matched non-tumor (NT) liver tissues (n = 180) as well as healthy livers (HL) devoid of chronic or acute disease (n = 10). Pearson’s chi-squared test was employed for significant correlation tests while univariate and multivariate survival analysis were performed by Cox proportional hazard ratio (HR) method.

Results: SLCt was overexpressed in 40.5% of T and 30.3% of NT as compared to HL. High SLCt in T was associated with microvascular emboli (p = 0.034) and expression of the cancer stem cell markers Sox2 (p = 0.025) and CD133 (p = 0.034). High SLCt in NT correlated with cirrhosis (p = 0.009) and presence of satellite nodules (p < 0.001). Univariate analysis showed association between high SLCt in T and shortened overall survival (OS) (HR = 1.08, p = 0.020), lower progression-free survival (PFS) (HR = 1.76, p = 0.006) as well as early recurrence-free survival (ERFS) (within 2 years post-surgery) (HR = 1.88, p = 0.008). In multivariate analysis, high SLCt tended to be an independent factor for OS, and this was strongly significant for PFS and ERFS. High SLCt in NT, is quite a poor outcome factor on late recurrence-free survival (HR = 2.33, p = 0.056) together with cirrhosis in univariate analysis, but remained dependent of cirrhosis in multivariate analysis. Late recurrence is linked to the intrinsic tumorigenic status of the liver.

Conclusions: Overexpression of the SLCt in HCC tumors is associated to stemness features and appears as a poor outcome factor impacting on early recurrence. Further, SLCt in NT is associated with development of de-novo HCC. Validation cohorts and prospective assessments are needed to define high SLCt as a potential biomarker of HCC stemness and patient outcome.

Delcath Announces Special Protocol Agreement Modification With FDA

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.

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.

AbbVie to Present at the 36th Annual J.P. Morgan Healthcare Conference

On January 10, 2018 Abbvie presented JP Morgan Conference presentation (Presentation, AbbVie, JAN 10, 2018, View Source;t=1 [SID1234523053]).