On March 29, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that a comparative summary of recently published research on the Company’s PHP Therapy was presented at the 2018 Society of Surgical Oncology Annual Cancer Symposium (SSO), held in Chicago, IL March 21-24, 2018 (Press release, Delcath Systems, MAR 29, 2018, View Source;p=RssLanding&cat=news&id=2340305 [SID1234525454]).

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!

In a presentation entitled Percutaneous Hepatic Perfusion (PHP) in Hepatic Liver Metastases, Jonathan Zager, MD, FACS, Chair of Graduate Medical Education at Moffitt Cancer Center and Professor of Surgery at the University of South Florida School of Medicine, compared the results from the Company’s prior Phase 3 study, published by Hughes, et al (Annals of Surgical Oncology, 2015) with more recent results published by Karydis, et al (Journal of Surgical Oncology, 2017) and Abbott, et al (American Journal of Clinical Oncology, 2017). The Hughes study was conducted from 2005 to 2010, and used an earlier generation of the Melphalan/HDS system, whereas the Karydis and Abbott studies evaluated patients primarily treated with the Generation Two version of the Melphalan/HDS system along with other refinements to the peri- and post-procedure management of patients.

Dr. Zager highlighted that in all three studies results with PHP provided evidence of improved efficacy, with Hughes showing a 5x increase in hPFS over the study control arm (PHP 245 days vs BAC 49 days), and Abbott showing significantly longer hPFS for PHP than treatment with chemoembolization (CE) and Yttrium-90 beads (Y90) (PHP 310 days, CE 80 days, Y-90 54 days). Karydis showed an overall response rate with PHP of 47%, a >84% disease control rate and hPFS of 9.1 months.

Regarding safety, Dr. Zager compared select safety data in the Hughes study conducted with the generation one system with data from the Karydis study conducted primarily in patients treated with the generation two system. The Hughes study was characterized by high percentages of hematologic side effects ranging from 60%-86% (anemia, thrombocytopenia, neutropenia). In the Karydis study, Grade 3 and 4 hematologic side effects (anemia, neutropenia, thrombocytopenia) were seen in approximately 30% of patients treated with PHP. Dr. Zager attributed this improvement in the safety profile to improvements in filtration with the generation two system, improved peri- and post-procedure management of patients, and greater experience in the treating centers. Dr. Zager concluded that PHP Therapy can be administered safely in high-volume cancer centers.

"Dr. Zager’s presentation at SSO provided a very useful overview of the efficacy consistently seen with PHP Therapy in appropriately selected patients, both in our original Phase 3 trial and in the more recent research," said Jennifer K. Simpson Ph.D., MSN, CRNP President and CEO of Delcath. "Importantly, the improvement in the safety profile noted by Dr. Zager provides confidence that our current Phase 3 FOCUS Trial in ocular melanoma liver metastases can address safety concerns expressed by the FDA after our original Phase 3 trial data was submitted, and can meet its objective of supporting an application for FDA approval for this important therapy."

On March 29, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2017 (Press release, IntelGenx, MAR 29, 2018, View Source [SID1234525061]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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!

2017 Fourth Quarter Financial Highlights:

Revenue was $1.5 million, compared to $1.9 million in the fourth quarter of 2016
Adjusted EBITDA was ($600,000), compared to $640,000 in Q4-2016
Cash and short-term investments totalled $4.9 million as at December 31, 2017
2017 Full-Year Financial Highlights:

Revenue was $5.2 million, unchanged from $5.2 million in 2016
Net comprehensive loss was $2.7 million, compared to net comprehensive loss of $1.5 million over the same period last year
Adjusted EBITDA was ($1.4 million), compared to ($280,000) in 2016
Recent Operating Highlights:

Regained exclusive worldwide rights to develop and commercialize RIZAPORT
Received a Notice of Allowance from the United States Patent and Trademark Office for a formulation specific orange book eligible patent for Montelukast VersaFilm
Site obtained GMP compliant rating from Health Canada for manufacturing and packaging activities
Initiated Phase 2a proof of concept Montelukast VersaFilm clinical trial in Alzheimer’s patients
"2017 was an important year, as we continued down the path to clinical and commercial success," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We have taken many important steps to support our efforts in pharmaceutical oral film development, manufacturing and commercialization, and remain on track for bringing our products to market. Moving forward, we believe that 2018 will represent a landmark period for IntelGenx, as we continue to advance our product pipeline, and begin clinical testing of our potentially groundbreaking Montelukast VersaFilm in Alzheimer’s patients."

Financial Results:

Total revenues for the three-month period ended December 31, 2017 amounted to $1.5 million, representing a decrease of $400,000 compared to $1.9 million for the three-month period ended December 31, 2016. The decrease is mainly attributable to upfront payments received in Q4-2016, partially offset by an increase in R&D revenues. Operating costs and expenses were $2.3 million for the fourth quarter of 2017, versus $1.5 million for the corresponding three-month period of 2016. For Q4-2017, the Company had an operating loss of $850,000, compared to operating income of $430,000 for the comparable period of 2016. Net comprehensive loss was $1.1 million, or $0.02 on a basic and diluted per share basis, for the fourth quarter of 2017, compared to net comprehensive loss of $22,000 or $0.00 on a basic and diluted per share basis, for the comparable period of 2016.

Total revenues for the twelve-month period ended December 31, 2017 amounted to $5.2 million, compared to $5.2 million for the twelve-month period ended December 31, 2016. Operating costs and expenses were $7.7 million for the full year 2017, versus $6.2 million for the corresponding 12-month period of 2016. For the twelve-month period of 2017, the Company had an operating loss of $2.5 million, compared to an operating loss of $980,000 for the comparable period of 2016. Net comprehensive loss was $2.7 million, or $0.04 on a basic and diluted per share basis, for the twelve-month period of 2017, compared to net comprehensive loss of $1.5 million, or $0.02 on a basic and diluted per share basis, for the comparable period of 2016.

As at December 31, 2017, the Company’s cash and short-term investments totalled $4.9 million, compared with $4.5 million as at December 31, 2016.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2017 as well as the 2018 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities March 29, 2018 at 4:00 p.m. EDT.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2017 fourth quarter and full year financial results March 29, 2018, at 4:30 p.m. EDT. The dial-in number for the conference call is (833) 211-3233 (Canada and United States) or (647) 689-3955 (International), conference ID 6786519. The call will be also be webcast live and archived for twelve months at www.intelgenx.com.

On March 29, 2018 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology drug development company, reported that commencement of an international phase II clinical trial of its lead program, GDC-0084 (Press release, Kazia Therapeutics, MAR 29, 2018, View Source [SID1234526004]).

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!

Key Points
• First site, Stephenson Cancer Center at the University of Oklahoma, has been initiated and will begin screening patients after the Easter holidays
• Study commencement follows a successful meeting with US Food & Drug Administration (FDA) in September 2017, and approval by Western Institutional Review Board in November 2017
• Initial focus will be on dose optimization in the treatment of newly-diagnosed patients with glioblastoma multiforme; adaptive study design will then seek to provide definitive evidence of clinical efficacy

GDC-0084 is being developed for glioblastoma multiforme (GBM), the most common and most aggressive form of primary brain cancer. The mainstay of current pharmacological treatment, temozolomide, is effective only in about one third of patients, and median survival is approximately 12 to 15 months from diagnosis.

Kazia licensed GDC-0084 in late 2016 from Genentech, a member of the Roche Group, where it had previously completed a phase I clinical study in 47 patients with advanced glioma.

Genentech’s phase I study demonstrated a favourable safety profile and provided signals of efficacy. Genentech also conducted an extensive preclinical program which showed encouraging results for GDC-0084 in animal models of glioblastoma.

Kazia CEO, Dr James Garner, commented, "the entire team has been working hard to design and implement the GDC-0084 clinical study. We are very pleased to now have the trial underway, and look forward to working with the participating clinicians. The need for new therapies in this disease remains immense, and we believe that GDC-0084 may have a valuable role to play in improving outcomes for patients with glioblastoma."

This phase II study will initially be conducted predominantly at leading US-based centres, in collaboration with specialist clinicians in the neuro-oncology field, and under an Investigational New Drug (IND) filing with the US Food and Drug Administration. The study is awaiting registration with clinicaltrials.gov, and will commence screening patients after the Easter holidays. Not all patients will qualify, and some may withdraw during the initial phase
of the study. It is anticipated that the study will provide an initial data read-out in early calendar 2019.

A video interview of Dr James Garner discussing the clinical study can be accessed via the
Kazia corporate website at View Source

The Company has also prepared an animation to explain the activity of GDC-0084, and this can be accessed via the
Kazia corporate website at View Source

Commencement of the trial follows the decision of the US FDA to grant orphan drug designation to GDC-0084 in glioblastoma in February 2018. Since in-licensing the program, Kazia has been working closely with clinicians and advisors to build a comprehensive development program which aims to move GDC-0084 towards a product registration in the swiftest and most effective way. To date, this has included extensive regulatory consultation,
manufacture of drug product for use in the phase II clinical trial, optimization of the intellectual property portfolio, and implementation of additional animal studies to support the further development of the drug.

Kazia Chairman, Iain Ross, commented, "this is an important achievement for the organisation. Two years ago, Kazia was an early-stage preclinical company. We now have two high-quality assets in clinical trials: Cantrixil in phase I for ovarian cancer and GDC-0084 in phase II for glioblastoma. The Board and Management have completed a significant
transformation of the organization so as to optimally support this clinical-stage portfolio, and we are now a lean, cost-effective, and highly-focused biotech."

He added, "we continue to be pleased with progress on the phase I study of Cantrixil, and look forward to reporting initial data from this study, which we expect will occur in the second calendar quarter of 2018."

On March 29, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) a clinical-stage biopharmaceutical company focused on the development of CART-cell therapies, reported that the company will present updates on its ongoing Phase I clinical trials at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14–18, 2018, in Chicago (Press release, Celyad, MAR 29, 2018, View Source [SID1234532518]). Poster presentations will feature updated data from Celyad’s THINK[1] trial, the new SHRINK[2] and LINK[3] trials in metastatic colorectal cancer, as well as data from a preclinical study showing that the addition of either the CD28 or 4-1BB co-stimulatory domains to CYAD-01 construct brings no benefit in terms of in vitro activity of the receptor.

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!

Poster Presentation Details:

Poster Title: The THINK clinical trial: Preliminary evidence of clinical activity of NKG2D chimeric antigen receptor T cell therapy (CYAD-01) in acute myeloid leukemia.

Poster Number: CT129

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 12

Download the poster

Poster Title: The SHRINK clinical trial: A phase I study assessing the safety and clinical activity of multiple doses of an NKG2D-based CAR-T therapy, CYAD-01, administered concurrently with the neoadjuvant FOLFOX treatment in patients with potentially resectable liver metastases from colorectal cancer.

Poster Number: CT123

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 6

Download the poster

Poster Title: The LINK clinical trial: A phase I study assessing the safety and clinical activity of multiple hepatic transarterial administrations of an NKG2D-based CAR-T therapy, CYAD-01, in patients with unresectable liver metastases from colorectal cancer.

Poster Number: CT134

Session Title: Phase I Trials in Progress

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 42, Poster Board 17

Download the poster

Poster Title: NKG2D as a chimeric antigen receptor – DAP 10 provides optimal co-stimulation for NKG2D based CARs.

Session Title: Adoptive Cell Therapy 3

Poster Number: 3583

Session Date & Time: Tuesday, April 17, 2018, 8:00 AM – 12:00 PM CDT

Location: Mc Cormick place south, Exhibit Hall A, Poster Section 24, Poster Board 21

On March 29, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, in particular against rare or resistant cancers, reported its consolidated full-year financials, as of December 31, 2017 and provided a business update (Press release, Onxeo, MAR 29, 2018, View Source [SID1234525063]).

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!

"2017 was a pivotal year for Onxeo that demonstrated the depth of our development pipeline and the strength of our translational expertise. Shortly following our decision to conclude the development of Livatag in liver cancer, we quickly and successfully shifted our focus towards innovative and high-value mechanisms of action in oncology, DNA-targeting and epigenetics. This strategic shift is supported by two key development assets, AsiDNA and belinostat, as well as our unique proprietary chemistry platform of decoy oligonucleotides, platON. AsiDNA, our first-in-class DNA repair inhibitor generated from this platform, is currently the subject of an extensive development program aimed at demonstrating the breadth of its potential applications in oncology. Importantly, our robust AsiDNA preclinical program has already generated compelling outcomes as a single therapy, as well as significant synergy in combination with other treatments, including belinostat or PARP inhibitors. AsiDNA will shortly enter its second phase I clinical trial, DRIIV, as a systemic monotherapy in solid tumors, with initial results expected before the end of 2018. These results will be crucial to confirming the potency of AsiDNA via systemic administration. Furthermore, we intend to expand our development pipeline in the near-term with new innovative molecules screened from the platON platform. Specifically, a new compound generated from platON is expected to enter pre-clinical development by the end of 2018. Finally, based on the divestment of multiple non-core products, our cost-reduction plan and a successful international private placement, the Company’s cash position of €14.3 million at the end of 2017 is expected to support the continued planned advancement of our development programs well beyond the key value-creating milestones anticipated this year," said Judith Greciet, CEO of Onx