On January 16, 2017 Cancer Research Technology (CRT), Cancer Research UK’s commercial arm, and Varleigh Dx (UK) Ltd, a clinical diagnostics development company, reported they have jointly launched a new test as an aid in the diagnosis of patients with pancreatic cancer (Press release, Cancer Research Technology, 16 16, 2017, View Source [SID1234523173]).

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This test is now CE marked, conforming to the European IVD Directive, and available for diagnostic use across the UK*.

The launch coincides with research published in the British Journal of Cancer ** showing that the test, which detects a protein called MCM5 involved in cell replication, can aid in the diagnosis of pancreatic cancer, supporting traditional cytological methods. The test is performed on samples which are routinely taken as part of the current pancreatic cancer management pathway.

Standard cytology tests, which look at cells collected from the tumour are sometimes not sufficiently sensitive to provide an accurate diagnosis. Often several repeat procedures are required to obtain a definitive diagnosis. The researchers showed that using the MCM5 test alongside standard cytology testing helped support the diagnosis of patients who had received unclear results from repeat cytological tests***.

The new laboratory test uses a simple colourimetric test to measure the concentration of antibodies bound to the MCM5 protein, which is present at higher levels in cells that are dividing rapidly, such as those found in malignant tumours.

Clive Richardson, Director of Varleigh Dx said: "This test for pancreatic cancer is the first of a number of new tests for MCM5 technology that we are developing to assist in the early detection of cancer."

The rights to commercialise the MCM5 assay – also known as the ELISA test – were licensed to Varleigh Dx by CRT after the protein biomarker was first identified as a cancer biomarker by Cancer Research UK-funded researchers at the University of Cambridge.

Professor Nick Coleman, who lead on this earlier work, added: "It’s great news that our research has led to new routes to translate these biological markers into ways to improve early diagnosis, for such an aggressive cancer."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "It’s always hugely satisfying to see discoveries originally made in the lab by Cancer Research UK scientists and licenced by CRT now reaching the stage where they can benefit patients and we’re delighted to have worked with Varleigh Dx to have made this possible.

"This should mean that more patients with this aggressive form of cancer can be diagnosed at the earliest possible stage, without having to undergo multiple invasive procedures."

On January 13, 2017 HOPE BIOSCIENCES reported that it has acquired the exclusive rights to develop and commercialize nuc-gemcitabine (APTA-12/HOPE-888) through a licensing agreement with AptaBio Therapeutics, a Korean pharmaceutical company (Press release, Hope Biosciences, JAN 13, 2017, View Source [SID1234609541]).

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nuc-Gemcitabine consists of Antisoma’s AS1411*, a clinically-tested DNA aptamer against surface nucleolin found on many cancer cells, and dFdCMP, an activated form of gemcitabine. Unlike ADCs (antibody drug conjugates) or SMDCs (small molecule drug conjugates), which require ‘linker’ conjugation of the cytotoxic payload to the drug, nuc-gemcitabine is created by incorporating a single activated gemcitabine molecule in lieu of a thymidine molecule during the one-step solid phase synthesis of the DNA aptamer.

Clinical trials in over 80 cancer patients showed AS1411 to have modest anti-cancer activity and a favorable safety profile. nuc-Gemcitabine is 100-1,000x more potent compared to AS1411 or conventional gemcitabine (Gemzar) in pre-clinical studies. Composition of matter patent has been granted in major countries, including the United States.

"Nucleolin is constantly and abundantly expressed on the cell surface of tumor cells where it serves as a binding protein for a variety of ligands implicated in cancer growth and angiogenesis," said Dr. SungHwan Moon, President and Chief Scientific Officer of AptaBio. "High nucleolin expression is correlated with decreased survival. nuc-Gemcitabine binds to surface nucleolin with high specificity and affinity, leading to internalization of the aptamer-drug into tumor cells, where it mediates cell death. We have demonstrated significantly greater anti-cancer activity at low doses of nuc-gemcitabine containing the equivalent of 3 mg/kg gemcitabine versus 80-100 mg/kg of Gemzar in gemcitabine-resistant pancreatic cancer xenograft mouse models."

"HOPE-888 has demonstrated impressive anti-cancer activity in preclinical models. It could truly be a game changing treatment strategy for pancreatic cancer and other difficult-to-treat malignancies," said George Uy, CEO and Founder of HOPE. "Our goal is to file IND application in the next 12-18 months and bring it into the clinic soon thereafter. We intend to truly personalize nuc-gemcitabine therapy by screening patients for nucleolin-expression with a biomarker kit."

On January 13, 2017 Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, reported that it has received a $20 million cash payment from Emergent BioSolutions pursuant to a promissory note granted as a result of the spin-off of Aptevo from Emergent, effective August 1, 2016 (Press release, Aptevo Therapeutics, JAN 13, 2017, View Source;p=irol-newsArticle&ID=2237367 [SID1234517410]).

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With the additional $20 million cash payment announced today, Emergent has provided a total of $65 million in cash contributions to fund Aptevo’s operations as a newly-launched oncology and hematology-focused company with a broad pipeline of commercial, clinical and preclinical assets and a proprietary bispecific technology platform, ADAPTIR, focused on the development of immuno-oncology therapeutics.

"The achievement of this final payment from Emergent marks another important milestone in Aptevo’s progress," said Marvin L. White, President and Chief Executive Officer. "With the generous funding provided by Emergent, and a strong portfolio of revenue-generating commercial assets, Aptevo is solidly positioned to achieve our near-term goals. Specifically, these include: capturing increased market share for our newly-launched Hemophilia B therapeutic, IXINITY; generating additional data from our two clinical-stage programs, otlertuzumab and MOR209/ES414; and rapidly advancing new ADAPTIR immuno-oncology candidates into clinical development."

About Aptevo Therapeutics Inc.

Aptevo Therapeutics Inc. is a biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Our core technology is the ADAPTIR (modular protein technology) platform. Aptevo has four commercial products in the areas of hematology and infectious diseases, as well as various investigational stage product candidates in immuno-oncology.

On January 12, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported update on key programs, potential milestones and estimated timelines (Press release, RedHill Biopharma, JAN 12, 2017, View Source [SID1234517389]).

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Micha Ben Chorin, RedHill’s CFO, said: "We are heading into 2017 with important potential catalysts in the coming months and with several ongoing Phase III and Phase II programs for gastrointestinal indications. Following the recently announced U.S. co-promotion agreement for Donnatal1, RedHill is advancing its strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with commercial presence in the U.S. This transition is planned to support potential future commercialization of RedHill’s Phase III-stage gastrointestinal drugs, if approved by the FDA. We are backed by strong institutional investors and maintain a debt-free balance sheet with approximately $70 million in cash, allowing us to continue to diligently execute our plans."

RHB-105 – H. pylori bacterial infection (confirmatory Phase III)

The confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to enroll 440 patients in up to 55 U.S. sites, is planned to be initiated by April 2017 following completion of an ongoing supportive pharmacokinetic (PK) program.
RHB-104 – Crohn’s disease (Phase III)

254 of the planned total of 410 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled first Phase III study in the U.S. and additional countries with RHB-104 for Crohn’s disease (the MAP US study).
A second independent data and safety monitoring board (DSMB) meeting of the MAP US study is expected in the second quarter of 2017, with an interim efficacy analysis and an option for early stop for success for overwhelming efficacy.
BEKINDA (RHB-102) – acute gastroenteritis (Phase III) and IBS-D (Phase II)

291 of the planned total of 320 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study). Top-line results are expected by mid-2017.
83 of the planned total of 120 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase II clinical study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line results are expected in mid-2017.
YELIVA – Phase I/II studies for multiple oncology and inflammatory indications

RedHill is currently pursuing several Phase I/II clinical studies with YELIVA in the U.S., targeting oncology indications, with support from National Cancer Institute (NCI) grants awarded to Apogee Biotechnology and U.S. universities, including ongoing studies for advanced hepatocellular carcinoma (Medical University of South Carolina), refractory or relapsed multiple myeloma (Duke University Medical Center ) and refractory/relapsed diffuse large B-cell lymphoma and Kaposi sarcoma (Louisiana State University Health Sciences Center).
Additional Phase I/II studies with YELIVA are in various stages of preparation, including a Phase Ib study to evaluate YELIVA as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy, planned to be initiated in the first half of 2017.
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)

As part of RedHill’s strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with a commercial presence in the U.S., the Company entered earlier this month into an exclusive co-promotion agreement with a subsidiary2 of Concordia International Corp. (NASDAQ:CXRX) (TSX:CXR), granting RedHill certain U.S. promotion rights for Donnatal, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel)3. RedHill expects to initiate promotion of Donnatal in the coming months.
RIZAPORT (RHB-103) – acute migraines (approved for marketing in Germany)

Re-submission of the RIZAPORT NDA to the FDA is expected in the first half of 2017. RIZAPORT was approved for marketing in Germany under the European Decentralized Procedure (DCP) in October 2015 and a first commercialization agreement was signed with Grupo JUSTE S.A.Q.F for Spain and a second commercialization agreement was signed with Pharmatronic Co. for South Korea. RedHill continues discussions with additional potential commercialization partners for RIZAPORT in the U.S., Europe and other territories.
About Donnatal:

Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal comes in two formulations: immediate release Donnatal Tablets and immediate release Donnatal Elixir, a fast acting liquid.

Donnatal is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.

Further information, including prescribing information, can be found on www.donnatal.com.

Please see the following website for important safety information about Donnatal: View Source

On January 12, 2017 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that patient treatment and data collection for the intrahepatic cholangiocarcinoma (ICC) cohort of its European Phase 2 HCC/ICC study is ongoing, and that the Company will announce interim results for the cohort once the data are fully mature (Press release, Delcath Systems, JAN 12, 2017, View Source;p=RssLanding&cat=news&id=2237085 [SID1234517366]). Additionally, the Company believes that the original goal to obtain an efficacy signal for the Phase 2 ICC cohort has been satisfied by the result of multicenter patient outcomes identified in the retrospective data collection of our commercial ICC cases conducted by our European investigators. These promising outcomes and observations were discussed with Key Opinion Leaders (KOL) at a Delcath-organized medical advisory panel meeting and led to the agreement that PHP therapy does, indeed, "demonstrate an efficacy signal in ICC and is worthy of full clinical investigation."

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The Company also announces that it has accepted an invitation from The Cholangiocarcinoma Foundation (CCF) to present its initial research plans for use of PHP therapy in the treatment ICC. The CCF is the largest patient advocacy organization devoted to finding a cure and improving the quality of life for patients with cholangiocarcinoma, or bile duct cancers. Company representatives will present a summary of European investigator findings and its clinical development plans for ICC to the Foundation’s medical advisory board at the CCF’s 2017 Annual Meeting, to be held in Salt Lake City, UT from February 1-3, 2017. Delcath will also provide a sponsorship grant to support the work of the CCF as part of its participation in the CCF Annual Meeting.

"Though the interim data we expected for ICC cohort in our Phase 2 trial in HCC/ICC are not yet available, the objectives for this study have largely been satisfied by the independent retrospective analysis conducted by our European investigators" said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "The promising outcomes and observations identified at our global KOL forum last year provide us with considerable confidence in the potential of our therapy in the ICC tumor type and helped form our initial research plan. The future research in ICC is designed to be cost effective and pursued in a financially prudent manner."

Dr. Simpson continued, "the CCF is one of the most important organizations for patients diagnosed with bile duct cancers, and the organization has attracted the participation of some of the leading researchers working on this difficult to treat disease. We are delighted with the opportunity to present to KOLs in this space the potential that the European investigators have identified for our therapy in the treatment of ICC."

About ICC
ICC is the second most common primary liver tumor and represents approximately 15% of new hepatocellular carcinoma (primary liver cancer or HCC) cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.