Patients with persistent or recurrent neutropenic fevers at risk of invasive fungal disease (IFD) are treated empirically with antifungal therapy (AFT). Early treatment using a diagnostic-driven (DD) strategy may reduce clinical and economic burdens. We compared costs and outcomes of both strategies from a UK perspective.
An empirical strategy with conventional amphotericin B deoxycholate (C-AmB), liposomal amphotericin B (L-AmB), or caspofungin was compared with a DD strategy (initiated based on positive ELISA results for galactomannan antigen) and/or positive results for Aspergillus species on polymerase chain reaction assay) using C-AmB, voriconazole, or L-AmB in a decision-analytic model. Rates of IFD incidence, overall mortality, and IFD-related mortality in adults expected to be neutropenic for ≥10 days were obtained. The empirical strategy was assumed to identify 30% of IFD and targeted AFT to improve survival by a hazard ratio of 0.589. AFT-specific adverse events were obtained from a summary of product characteristics. Resource use was obtained, and costs were estimated by using standard UK costing sources. All costs are presented in 2012 British pounds sterling.
Total costs were 32% lower for the DD strategy (£1561.29) versus the empirical strategy (£2301.93) due to a reduced incidence of adverse events and decreased use of AFT. Administration of AFT was reduced by 41% (DD strategy, 74 of 1000; empirical strategy, 125 of 1000), with similar survival rates.
This study suggests that a DD strategy is likely to be cost-saving versus empirical treatment for immunocompromised patients with persistent or recurrent neutropenic fevers.
Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

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On April 4, 2016 XBiotech Inc. (NASDAQ: XBIT) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated review for Marketing Authorization of Xilonix, the Company’s first-in-class True Human monoclonal (IgG1k) antibody treatment for advanced colorectal cancer (Press release, XBiotech, APR 4, 2016, View Source [SID:1234510424]). The CHMP grants accelerated review for medicines deemed to be of public health importance and that represent therapeutic innovation. The accelerated review procedure allows the CHMP to grant an opinion two months earlier than the normal 210-day procedure. With this action, a decision on Xilonix’s approval could come as early as third quarter 2016.

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Xilonix is XBiotech’s lead True Human therapeutic antibody and a potential breakthrough for patients with advanced colorectal cancer. Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis (the growth and spread of tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., loss of weight and muscle mass), fatigue and anxiety associated with advanced cancer.

XBiotech recently received validation of its Marketing Authorization Application (MAA) for Xilonix based on results of a Phase III study, which showed a 76% relative improvement in response rate in patients treated with the antibody, as compared to placebo (p=0.0045). Patients treated in the Phase III study had colorectal tumors that were metastatic or inoperable, had failed all recommended forms of chemotherapy and most other forms of therapy, and suffered from symptoms including pain, fatigue, anorexia and wasting. The patients treated in the Phase III study were considered to represent a large patient population that is physically and emotionally exhausted from the disease and treatment-related toxicities.

"XBiotech is encouraged by CHMP’s action to grant accelerated review of Xilonix," said John Simard, Chairman, Chief Executive and founder of XBiotech. "There is an urgency to provide advanced colorectal cancer patients with access to new treatments that have been developed with their specific needs in mind."

In the U.S., Xilonix has received Fast Track designation by the Food and Drug Administration (FDA) for the treatment of advanced colorectal cancer.

About Colorectal Cancer

Colorectal cancer is the second leading cause of malignancy in the industrialized world. The incidence of colorectal cancer increases with economic development and aging, hence incidence is rising worldwide. In Europe, approximately 470,000 patients will be diagnosed with colorectal cancer in 2016, and half of this number will progress and ultimately succumb to the disease. Disease progression is associated with significant morbidity, functional impairment and failure of multiple therapies often with substantial toxicities. Patients with advanced disease are thus symptomatic and intolerant to further treatment-related morbidity. New anti-cancer options are needed for patients suffering from advanced colorectal cancer.

About XBiotech’s True Human Therapeutic Antibodies

Unlike antibodies found in other therapies, XBiotech’s True Human antibodies are 100 percent human and derived from healthy people with natural immunity to heal and protect others. By rethinking the approach to antibody therapy, XBiotech developed a proprietary technology to identify, isolate and manufacture human antibodies derived from the body that finally work in harmony with it.

On April 4, 2016 Israeli cancer metabolism company Metabomed LTD. reported that it has completed an extension of its Series A round from current and new investors, bringing the total of its raise to $ 18 million (Press release, Metabomed, APR 4, 2016, View Source [SID:1234510367]). Existing investors include MS Ventures, Boehringer Ingelheim Venture Fund (BIVF), Pontifax Fund, and the Technion Research and Development Foundation. New investors Pfizer Inc. (NYSE: PFE) and Arkin Holdings also joined the round. The final transaction is subject to the successful completion of the approval process by the Israel Antitrust Authority.

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Metabomed was co-founded by MS Ventures and three leading researchers in the field of cancer metabolism and computational biology — Prof. Eyal Gottlieb from the Beatson Institute for Cancer Research in Glasgow, UK, Prof. Eytan Ruppin from Tel Aviv University and the University of Maryland, and Prof. Tomer Shlomi from the Technion Israel Institute of Technology.

Metabomed is focusing on the discovery and development of potential small molecule drugs directed against novel targets in the field of cancer metabolism. Based on its proprietary interdisciplinary target identification platform, Metabomed utilizes a unique approach to discovery, which allows the company to potentially identify new targets that form a synthetic lethal gene pair with metabolic genes inactivated in cancer cells. By inhibiting these targets, Metabomed intends to develop more selective anti-cancer drugs that may potentially be highly targeted, and therefore sparing of normal cells.

Metabomed operates out of the state-of-the-art facilities at the MS Ventures Israel BioIncubator, which has supported the development of the new start-up with its infrastructure and a wide range of incubation services. Following the completion of this round, Simone Botti, current Head of the MS Ventures Israel BioIncubator, will leave his position in order to join Metabomed as its full-time CEO.

Simone Botti commented: "This Series A extension is a major success for Metabomed.. We believe that the vote of confidence from the existing syndicate and the addition of new top tier investors such as Pfizer and Arkin Holdings confirm the excitement around Metabomed and its technology, and I am very honored to have been chosen to lead the company as its CEO."

"We are proud to work with companies such as Metabomed that are exploring exciting and innovative technologies that may help lead to potential new treatment options in the field of oncology," said Robert Abraham, Ph.D., Senior Vice President and Head of Pfizer’s Oncology-Rinat Research & Development Group, who will also become a member of Metabomed’s scientific advisory board. "Metabomed shares in our mission to deliver safer and more effective medicines to our patients."

On April 4, 2016 CRT reported that it has signed an agreement with CiMass, under which CiMass will test a proprietary monoclonal antibody in combination with natural killer cells for the treatment of cancer (Press release, Cancer Research Technology, APR 4, 2016, View Source [SID1234523501]).

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CiMaas is developing cellular immunotherapy for various cancer patients, including natural killer cells for adoptive transfer to patients with breast cancer and multiple myeloma. Natural killer cells are able to efficiently kill cancer cells, but this killing can still be enhanced by addition of monoclonal antibodies. The current agreement allows CiMaas to further develop a monoclonal antibody directed against an undisclosed target to enhance the immune response mediated by natural killer cells to tumour tissue.

CiMaas will use additional technology to improve the antibody and test its efficacy in proof of concept experiments. Under the agreement CiMaas receives one year exclusivity to explore the antibody’s functionality in natural killer cell-related therapies and CRT receives a signature fee in return.

Results from studies assessing the association between anticholinergic use and falls are mixed, and prior studies are limited in their ability to control for important potential confounders. Thus, we sought to examine the association between anticholinergic medication use, including over-the-counter medications, and recurrent falls in community-dwelling older women.
We analyzed data from a prospective cohort study of women aged 65 to 79 years from the Women’s Health Initiative Observational Study and Clinical Trials. Women were recruited between 1993 and 1998, and analyses included 61,451 women with complete information. Medications with moderate or strong anticholinergic effects were ascertained directly from drug containers during face-to-face interviews. The main outcome measure was recurrent falls (≥2 falls in previous year), which was determined from self-report within 1.5 years subsequent to the medication assessment.
At baseline, 11.3 % were using an anticholinergic medication, of which antihistamines (commonly available over-the-counter) were the most common medication class (received by 45.2 % of individuals on anticholinergic medication). Using multivariable GEE models and controlling for potential confounders, the adjusted odds ratio for anticholinergic medication use was 1.51 (95 % CI, 1.43-1.60) for recurrent falls. Participants using multiple anticholinergic medications had a 100 % increase in likelihood of recurrent falls (adjusted odds ratio 2.00, 95 % CI 1.73-2.32). Results were robust to sensitivity analysis.
Anticholinergic medication use was associated with increased risk for recurrent falls. Our findings reinforce judicious use of anticholinergic medications in older women. Public health efforts should emphasize educating older women regarding the risk of using over-the-counter anticholinergics, such as first-generation antihistamines.

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