DARMSTADT, Germany, Oct. 12, 2018 /PRNewswire/ —

Not intended for U.S media 

• Merck-sponsored survey developed in collaboration with IACO and Eurocarers reveals lifelong effects of caring for a loved one with MS 
• #MSInsideOut documentary film, executively produced by Shift.ms, provides artistic take on the experiences of those impacted by MS 

Merck, a leading science and technology company, today announced the publication of results from a global Merck-sponsored multiple sclerosis (MS) carer survey, as well as the premiere of the #MSInsideOut documentary film, Seeing MS from the Inside Out, executive produced by Shift.ms, a social network for people with multiple sclerosis, at the 34^th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS), in Berlin, Germany.

To view the Multimedia News Release, please click:
https://www.multivu.com/players/uk/8411851-merck-survey-and-film-multiple-sclerosis/

The ‘Living with Multiple Sclerosis: The Carer‘s Perspective report was developed in collaboration with The International Alliance of Carer Organizations (IACO) and Eurocarers to examine the experiences of 1,050 multiple sclerosis (MS) carers across seven countries (US, Canada, UK, France, Germany, Italy and Spain). The survey found that almost half (48%) of those surveyed became MS carers when they were below the age of 35, and nearly one in three had been caring for somebody for 11 years or more.

Additional key findings from the carer survey included:

• 43% and 28% of carers surveyed reported an impact on their emotional/mental health and physical health respectively
• 34% said being an MS carer impacted their financial situation, more than a third (36%) stated they had to take time off work, and as a result, 84% of those carers reported their work and career being impacted
• Only 15% of carers surveyed connected with other carers or patient organisations to help cope with the challenges of their role

“MS can be a devastating disease for both patients and carers, with the responsibilities assumed by carers over an extended length of time and intensifying as the disease progresses. Carers can experience a profound impact on their physical and emotional health, finances, and employment,” said Nadine Henningsen, Board Chair, IACO. “Not surprisingly, the survey results reinforced the large number of young people who are becoming carers – often in a formative time of their life.”

As part of the #MSInsideOut campaign, an initiative aimed at providing a deeper understanding of MS, the MS Inside Out documentary film, ‘Seeing MS from the Inside Out‘, will be premiered. Developed with Shift.ms as executive producers, it is the first global documentary film to pair artists and people from across the MS community, with a view to interpreting the experiences and perspectives of those impacted by MS through art.

“In line with our broader mission at Shift.ms, the aim of this documentary is to highlight the individual stories in a unique and innovative way across the MS community, digging deeper into the elements of MS that remain under-represented with a view of interpreting the unmet needs of those impacted by MS through art,” said George Pepper, Co-founder and CEO, Shift.ms. “By bringing these stories out into the open we will be able to address those challenges that remain, opening lines of communication and ultimately raising awareness of MS.”

The documentary follows three stories: Maria Florencia, a person living with MS from Argentina, Jon Strum, a caregiver from the US, and Dr. Luigi Lavorgna, a healthcare professional from Italy. Each was paired with a local visual artist to bring their stories to life through an emotional interpretation not bound by words but through art, reflecting the often difficult-to-explain nature of MS.

The premiere will take place at 18.00 – 19.30 CEST today on October 11, during ECTRIMS 2018 and can be accessed through a livestream link here: http://www.touch-stream.com/MSinsideout

“At Merck, we are extremely proud to highlight the unmet needs in the community through our work with Shift.ms, IACO and Eurocarers which expose the experiences of different members of the MS community, including the perspective of MS carers, whose voices have traditionally not been heard as strongly,” said Andrew Paterson, Senior Vice President, Global Head of Neurology and Immunology, at the biopharma business of Merck. “Forming part of our ongoing company-wide commitment to carers, and connecting with the broader Embracing Carers initiative, the outcomes from both the survey and documentary film highlight the need for additional support and awareness. We therefore encourage and call upon the MS community to take these findings and identify ways in which they can better assist both MS carers and patients.”

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Multiple Sclerosis 

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

Merck in Multiple Sclerosis  

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). Merck’s current portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet needs.

About Merck 

Merck is a leading science and technology company in healthcare, life science and performance materials. More than 53,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2017, Merck generated sales of € 15.3 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.  

About Embracing Carers  

Embracing Carers is a global initiative led by Merck KGaA in collaboration with leading caregiver organizations around the world designed to increase awareness, discussion, and action about the often-overlooked needs of caregivers. Given that caregivers need support and often do not know where to turn for help, Embracing Carers was created to help fill that void.

About IACO 

The International Alliance of Carer Organizations (IACO) is a global coalition of 15 member nations committed to building a global understanding and respect for the vital role of family carers. Recognized as an official NGO by the United Nations, IACO works to improve the quality of life and support the needs of carers, through international partnerships and advocacy that strengthens and honors the voice of carers. To learn more, visit http://www.internationalcarers.org.

About Eurocarers 

Eurocarers is the European umbrella organisation representing informal carers and their organizations, irrespective of the particular age or health need of the person they are caring for. Eurocarers works to raise awareness of the significant contribution made by carers to care systems while ensuring that all relevant policies across Europe take account of their needs and preferences. To learn more, visit http://www.eurocarers.org.

About Shift.ms 

Shift.ms – http://www.Shift.ms – is the social network for people with multiple sclerosis. Founded by MSers, for MSers, the charity supports many thousands of recently diagnosed people across the world as they make sense of MS. It’s independent and it’s free.

About #MSInsideOut 

#MSInsideOut is a campaign supported by Merck which focuses on understanding the journeys people living with MS face and telling the inside story of the disease. For more than 20 years, Merck has been relentlessly focused on understanding the journey people living with MS face to create a meaningful, positive experience for them and the broader MS Community. With the #MSInsideOut campaign Merck aims to better understand MS and, importantly, enable others to do the same.

 

TOKYO, Oct. 12, 2018 /PRNewswire/ — Mundipharma has launched ISODINE^® Throat Candy in Japan. It comes in 3 flavors — Fresh Lemon, Honey Kumquat and Peppermint.

Mundipharma intends to launch to ISODINE^® Throat Candy in other markets. Outside of Japan, ISODINE^® is widely known as BETADINE^® — Mundipharma’s flagship consumer healthcare brand.

It is an original formula that contains zinc and hesperidin, which are considered good for the throat. It moisturizes a dry throat, which makes it less likely to pick up viruses and bacteria that cause infection.

Mundipharma CEO, Raman Singh said, “It’s very exciting to be launching a candy range that tastes great, because while it has healthcare benefits, it’s a slightly different type of product for us. It doesn’t replace the need for our existing BETADINE^® upper respiratory treatments and it’s an excellent complement to our portfolio.

“I’m excited to see this rolled out in other countries as we continue to build the BETADINE^® portfolio,” he added.

About Mundipharma           

Mundipharma is a network of independent associated companies which are privately owned entities covering pharmaceutical markets in Asia-Pacific, Latin America, Middle East and Africa. The headquarters for these territories is in Singapore. Mundipharma is a prime example of a company that consistently delivers high quality products while standing by the values that represent the company. Our mission is to alleviate the suffering of patients and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare.

About BETADINE^®   

The BETADINE^® range of products is trusted by hospitals around the world for over 55 years to prevent and treat infections. It is a trusted brand among consumers at home to treat small wounds and grazes, sore throats, feminine infections. This stops minor problems from escalating into big issues. In-vitro studies show that BETADINE^® medicines that contain povidone-iodine kill a broad range of bacteria, viruses and fungi that cause infections, including antibiotic-resistant strains. BETADINE^® has four main categories of products in Wound Care, Throat / Oral Care and Feminine Care. BETADINE™ Daily Gentle Protection range does not contain povidone-iodine.

®: BETADINE and ISODINE are Registered Trademarks of Mundipharma

Logo – http://photos.prnasia.com/prnh/20150302/8521501264LOGO

Source: Indonesian Ministry of Women Empowerment and Child Protection (Kemen PPPA)

BALI, Indonesia, Oct. 12, 2018 /PRNewswire/ — In Nusa Dua, the largest AIDS organization in the world, AIDS Healthcare Foundation (AHF) is highly concerned about the declining international funding for HIV/AIDS treatment in developing countries, including Indonesia.

As a matter of fact, the ability of the Indonesian government to deal with people with HIV/AIDS is inadequate. “Of the approximately 360 thousand people with HIV/AIDS, only 290 thousand people can be handled,” said AHF Indonesia Country Program Manager, Riki Febrian, at Santika Siligita Hotel, Nusa Dua, Bali, Thursday, October 11, 2018.

Riki said that international funding for HIV/AIDS treatment in developing countries, including Indonesia, was recently reduced. This happened because the World Bank imposed a new classification on Middle Income Country (MIC). The World Bank sets a country where people earn US$ 2.73 per day, or about as much as the price of a cup of coffee in many countries, is not included in a group of poor countries.

“In fact, donor agencies or institutions, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, uses the World Bank income scales to determine the countries eligible for their funding,” said Riki.

Considering Indonesia belongs to the MIC category, Riki added, international aid for Indonesia has shrunk and this has worsened the handling of HIV/AIDS in this country. All this time, as much as 80% of funds for handling HIV/AIDS in Indonesia come from outside. “Because we are now considered to be rich, other countries and funding agencies stop their support,” said Riki.

Therefore, during the Annual Meeting of the World Bank and International Monetary Fund (IMF) in Nusa Dua, Bali, 8-14 October 2018, AHF calls on the World Bank to change its policy regarding the classification of middle income countries (MIC).

AHF, among others, pursues creative ways to campaign for the need to change the country classification by distributing “World Bank Coffee” for free around the arena of the annual meeting of the World Bank – IMF in Nusa Dua. In the cup is written “$ 2.73 per day is not middle income“.

“AHF is asking the World Bank’s attention through coffee, because 2.73 US dollars is equivalent to the price of a cup of coffee,” said AHF Asia Advocacy and Marketing Manager, Marie Ko.

The reduced funding for handling HIV/AIDS in Indonesia is indeed a big concern, considering the fund needed for HIV/AIDS treatment is quite large. According to an activist of the Indonesian Family Planning Association (PKBI), Muvitasari, this year Indonesia needs Rp 4.2 trillion to deal with HIV/AIDS. The funds come from the APBN, APBD, CSR, various aids and fundings   from international donor agencies.

“In 2023, the required funds will increase to Rp. 11.6 trillion,” said Muvitasari.

Therefore, AHF continues to urge the World Bank to rectify its classification method regarding MIC. “The World Bank must re-calculate about MIC,” said Riki.

AHF is a non-profit organization based in Los Angeles, United States. AHF currently provides care or medical services to more than 1 million people with HIV/AIDS in 41 countries, spread across the US, Africa, Latin America, the Caribbean, Asia Pacific, and Eastern Europe.

Photo – https://photos.prnasia.com/prnh/20181012/2266101-1

VIENNA, Oct. 11, 2018 /PRNewswire/ — YITU Technology was featured at the 3rd “Bridges for Cities – Belt and Road Initiative: Developing Green Economies for Cities” in Vienna to showcase its advanced smart city solutions as one of the leading companies representing a case city: Shanghai.

The “Bridges for Cities” event, jointly held by United Nations Industrial Development Organization (UNIDO) and Finance Center for South-South Cooperation (FCSSC), aims to deliver concrete outcomes to facilitate the implementation of sustainable urban-industrial development projects in cities across the Belt and Road and beyond. Over 188 cities from 88 countries attended the event.

In Vienna, YITU shared its insights and practice of AI technology on how the company is engaged in Shanghai’s urban intelligent development, as well as demonstrated a use case in the form of AI-enhanced healthcare as part of Shanghai’s smart city exhibition. YITU’s intelligent healthcare solutions are currently adopted seamlessly into clinical work flow by over 100 top-ranked hospitals in China, showing great potential for a future intelligent healthcare system.

“AI will play a crucial role in the progress of building smart cities by automating essential functions and aid city planning. To accomplish such a goal, AI companies shoulder great responsibilities to find a commercial use for the technology so that cities can be more intelligent and convenient for their inhabitants,” said Fan Jingyan, Vice President, Government Affairs of YITU Technology. “Over 30 countries and regions have been benefited from YITU’s state-of-the-art AI technologies to contribute to create a better, smarter and more convenient world.”

Bernardo Calzadilla-Sarmiento, UNIDO’s director of Department of Trade, Investment and Innovation commented, “it’s impressive to see how much AI is changing human society. We look forward to seeing YITU share its experience to more cities around the world.”

Shanghai is one of the four case cities to demonstrate their urban industrial solutions at the event, chosen specially by UNIDO for their potential to adopt new technologies for positive change. These pioneer cities introduced the projects they have currently implemented and discussed the trends and challenges for future smart urban cities. Shanghai’s planners are banking on smart city development and intelligent manufacturing to further enhance the city’s global reputation. As one of the companies representing Shanghai and an avid participant in Shanghai’s intelligent city development, YITU has been sharing its experience and expanding its cooperation with cities across the Belt and Road region and beyond.

In September, YITU and UNIDO ITPO Shanghai (Investment and Technology Promotion Office of the United Nations Industrial Development Organization) signed a strategic cooperation agreement for promoting the growth of developing countries assisted with AI technology. YITU has always been committed to helping more cities around the globe with its leading technologies, and strategic partnerships with international organizations including UNIDO will accelerate this vision.

Along with working closer together with UNIDO, YITU is widely acknowledged for its AI capabilities and efficiencies that contribute to higher and bigger international platforms. It not only shows technology innovation has become mainstream in sustainable development, but also that Chinese companies are becoming a significant and leading force in global sustainable development.

About YITU Technology

YITU Technology (YITU) is a pioneer in practical artificial intelligence (AI) research and innovation that provides advanced AI-based business solutions to build a safer, better and healthier world. YITU owns a world-class R&D team that drives industrial development to find comprehensive solutions in the areas of machine vision, speech and language understanding.

View original content to download multimedia:http://www.prnewswire.com/news-releases/yitu-showcases-smart-city-solutions-at-unido-event-to-enhance-global-urban-livability-300729236.html

Source: Menarini I.F.R.

SYDNEY, Oct. 10, 2018 /PRNewswire/ — Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce the successful completion of Part A, the dose escalation component, of its phase I study of Cantrixil in ovarian cancer. 

After discussion by the Data Monitoring Committee, the study has determined a maximum tolerated dose (MTD) of 5 mg/kg, and it is expected that this dose will be used for subsequent clinical investigation. Preclinical data suggests that this dose should be sufficient to detect potential therapeutic effects of Cantrixil.

The study will now move into Part B, a dose expansion cohort, which is designed to seek preliminary evidence of efficacy. Part B will recruit a further 12 patients, all of whom are expected to be dosed at the MTD of 5mg/kg. The company expects to be able to conclude Part B in calendar 2019.

Kazia CEO, Dr James Garner, commented, “We are delighted with progress in the Cantrixil study. The first hurdle for any drug in development is safety, and so it is highly encouraging that we have achieved in Part A of the trial a dose for Cantrixil towards the upper end of the range that we set out to explore. The study will now immediately transition into Part B, which will provide important insights into the potential efficacy of Cantrixil, building on the preliminary data that was announced in June 2018. We are grateful to the clinicians and patients who have driven the study forward so far, and we look forward to seeing further progress in due course.”

To date, 14 patients have been enrolled in the Cantrixil phase I study, all with ovarian cancer that has failed at least two prior lines of treatment and, of these, 11 have been well enough to receive treatment with Cantrixil. The most common side effects seen with Cantrixil administration have been abdominal pain, fatigue, and vomiting. Several patients continue to receive study drug at this time and as a result no further interim efficacy data is available at this point. The company is planning opportunities for publication of emerging safety and efficacy data with participating clinicians, and looks forward to sharing a comprehensive analysis in the near future, within the context of a suitable academic forum or publication.

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes two clinical-stage drug development candidates, and we are working to develop therapies across a range of oncology indications.

Our lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, GDC-0084 entered a phase II clinical trial in March 2018. Initial data is expected in early calendar 2019. GDC-0084 was granted orphan designation for glioblastoma by the US FDA in February 2018.

TRX-E-002-1 (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells, and is being developed to treat ovarian cancer. TRX-E-002-1 is currently undergoing a phase I clinical trial in Australia and the United States. Initial data was presented in June 2018 and the study remains ongoing. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015.

Logo – https://photos.prnasia.com/prnh/20171120/1996749-1LOGO

BUDAPEST, Hungary, Oct. 10, 2018 /PRNewswire/ —

AnyScan (SPECT/CT/PET) triple modality system

Breakthrough scientific collaboration between National Physical Laboratory (NPL) and Mediso Medical Imaging Systems Ltd. has begun in the United Kingdom after installation of a newly procured triple modality AnyScan (SPECT/CT/PET) system.

The new triple modality system provides the benefit of much higher sensitivity and resolution compared to conventional SPECT imaging. The excellent SPECT image quality is a direct result of the novel three-headed SPECT detector technology and the applied multi-pinhole collimation. Enabling image quality levels that are comparable with those normally seen in PET. This unique multimodality imaging system enables SPECT, CT and PET studies to be performed in one room. A feature that will benefit a number of customers and their patients.

“The AnyScan system will deliver major new capabilities at NPL as part of our new Metrology for Medical Physics Centre (MEMPHYS), supporting rapid acceleration for the development and implementation of innovative early diagnostic and therapeutic technologies, for conditions such as cancer, dementia and heart disease into clinical practice,” said Dr. Andrew Robinson, Head of Nuclear Medicine Metrology, National Physical Laboratory, Teddington, Middlesex UK.

“It had great significance to equip NPL with our state-of-the-art appliance,” said István Bagaméry, Managing Director of Mediso Ltd. “AnyScan is our flagship equipment which brings nuclear and molecular imaging expectations to the limits. During our collaboration we will incorporate the findings to our imaging products. It is crucial for us to utilise the results from the NPL project and make them accessible for other users as well.”

The AnyScan camera will allow NPL to develop unique measurement capabilities and deliver the first SPECT/CT/PET scanner in the world directly calibrated against primary standards of radioactivity, providing clinicians and pharmaceutical developers with confidence in their medical image decision-making and progress of clinical drug trials.

Mediso introduction  

Mediso Ltd. works in the field of nuclear and molecular imaging focusing on development, manufacturing, sales and servicing of multi-modality in-vivo imaging systems. The AnyScan® family is the first triple modality choice for clinical imaging. The system was sold, installed and supported by Bartec Technologies Ltd. Mediso’s exclusive representative in UK and Ireland.

NPL introduction

The National Physical Laboratory (NPL) is the UK’s National Measurement Institute, and is a world-leading centre of excellence in developing and applying the most accurate measurement standards, science and technology available.

Contact: Mr. Zsombor Nagy, zsombor.nagy@mediso.com , +36-30-242-5308

DARMSTADT, Germany, Oct. 9, 2018 /PRNewswire/ —

Not intended for distribution in the USA, Canada or UK 

ESMO Abstract #

Avelumab: LBA6_PR, 659P, 1290P, 1291P, 1282P, 877P; M7824 (TGF β-trap/anti-PD-L1):1048O, 1463P, 1931P, 757P, 643P, 642P, 661P; tepotinib (MET kinase inhibitor): 1377O, 621PD, 698P; M6620: 1437P; M3814: 1845P; M7583: 1014PD; abituzumab: 487P; Erbitux®(cetuximab): 124P, 484P, 509P, 493P, 521P, 510P, 481P, 486P, 1057P, 1108P, 1068P, 1064P, 1293P

• First presentation of Phase III data for avelumab (plus axitinib) in previously untreated, advanced kidney cancer
• New and updated data for bifunctional immunotherapy M7824  
• Results from Phase II trials for tepotinib, including in EGFR TKI-resistant NSCLC  
• Additional pipeline data feature abstracts for a further four innovative agents across multiple tumor types with a significant patient need 

Merck, a leading science and technology company, today announced that new data from a variety of high-priority clinical development programs will be presented at the ESMO 2018 Congress (European Society for Medical Oncology Annual Meeting), October 19-23, 2018, Munich, Germany.

In the year that Merck celebrates its 350-year anniversary, abstracts at the congress represent a company record with eight therapeutic agents across 14 tumor types, reinforcing Merck’s position at the forefront of clinical development in oncology.

“Our data at this year’s European Society for Medical Oncology Congress expand our understanding of avelumab in renal cell carcinoma and other tumors, and demonstrate the headway we are making with our pipeline, including bifunctional immunotherapy M7824 and tepotinib,” said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck. “We look forward to many more years of real and significant progress towards our vision of transforming the management and treatment of cancer.”

Data from the Phase III study JAVELIN Renal 101, evaluating avelumab* in combination with axitinib, compared with sunitinib as initial therapy for patients with advanced renal cell carcinoma (RCC), will be presented for the first time during the Presidential Symposium at ESMO on Sunday, October 21, 2018 at 5:20 PM – 5:35 PM CEST. Avelumab is being jointly developed and commercialized with Pfizer. The results represent the first positive Phase III immunotherapy trial in combination with a tyrosine kinase inhibitor (TKI) in any tumor type, supporting Merck’s interest in the potential use of avelumab in combination with currently approved therapies and novel agents. These results will be submitted for publication in a peer-reviewed journal. Other updates include new avelumab data in Merkel cell carcinoma (MCC) and advanced gastric or gastroesophageal junction (GEJ) cancer.

New data for M7824 will be presented from expansion cohorts of two ongoing Phase I clinical trials, including the first tumor-specific data for squamous cell carcinoma of the head and neck (SCCHN), biliary tract cancer, esophageal squamous cell carcinoma and esophageal adenocarcinoma. In addition, updated data for M7824 in patients with gastric cancer and non-small cell lung cancer (NSCLC) will be shared. M7824, discovered in-house at Merck, is an investigational bifunctional immunotherapy designed to combine a transforming growth factor β (TGF-β) trap by ‘fusing’ it with the anti-programmed death ligand-1 (PD-L1) mechanism. To date more than 650 patients with various types of solid tumors have been treated across the program with M7824 and the safety profile is consistent with that observed with other PD-1/PD-L1 inhibitors and previously described skin lesions (keratoacanthomas, SCC, hyperkeratosis) associated with TGF-β-inhibiting therapies.

Data for tepotinib** include results from three Phase II trials in epidermal growth factor receptor (EGFR) TKI-resistant NSCLC and advanced hepatocellular carcinoma, providing further evidence of this precision medicine’s potential clinical activity in a range of tumors. Tepotinib, discovered in-house at Merck, is an investigational, oral MET inhibitor that is designed to selectively inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations or MET protein overexpression.

Additional pipeline abstracts feature updated data from Merck’s comprehensive DNA damage response (DDR) portfolio. These include results from a Phase I trial investigating M6620 (formerly VX-970) in combination with gemcitabine in patients with advanced NSCLC, and combined data from two Phase I trials of DNA-dependent protein kinase inhibitor, M3814. Results will also be shared from a Phase I/II trial of M7583, a Bruton’s TKI, in patients with B-cell malignancies, as well as a retrospective analysis of the Phase I/II Poseidon study investigating abituzumab in patients with metastatic colorectal cancer (mCRC).

Data to be presented at the congress for Erbitux^® will add to the growing body of real-world evidence supporting the therapy’s role as a standard of care in RAS wild-type mCRC and first-line recurrent or metastatic SCCHN (R/M SCCHN), and for patients with locally advanced SCCHN (LA SCCHN) who may not be able to tolerate cisplatin-based regimens in full.  

*Avelumab is under clinical investigation for the treatment of RCC, MCC, CRC, gastric and GEJ cancer, and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for RCC, CRC, gastric or GEJ cancer by any health authority worldwide.

**Tepotinib is the recommended International Nonproprietary Name (INN) for the MET kinase inhibitor MSC2156119J. Tepotinib is currently under clinical investigation and not approved for any use anywhere in the world.

Tepotinib, M7824, M3814, M7583, M6620 and abituzumab are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

Notes to Editors 

Key Merck-supported abstracts slated for presentation are listed below. In addition, a number of investigator-sponsored studies have been accepted (not listed).

About Avelumab 

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.^[1]–[3] Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.^[3]–[5] In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including seven Phase III trials, and more than 8,600 patients across more than 15 different tumor types. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.

Approved Indications in the US 

The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO^®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the US FDA Approved Label 

The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or mUC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

About M7824 

M7824 is an investigational bifunctional immunotherapy that is designed to bring together a TGF-β trap and ‘fuse’ it with the anti-PD-L1 mechanism. M7824 is designed to simultaneously block the two immunosuppressive pathways – targeting both pathways aims to control tumor growth by potentially restoring and enhancing anti-tumor responses. M7824 is currently in Phase I studies for solid tumors.

About Tepotinib 

Tepotinib (MSC2156119J) is an investigational, oral MET inhibitor that is thought to inhibit oncogenic MET receptor signaling caused by MET (gene) alterations, including both MET exon 14 skipping mutations and MET amplifications, or MET protein overexpression. It is a precision medicine and is designed to have a highly selective mechanism of action.

About M6620 

M6620 (previously known as VX-970) is an investigational small-molecule thought to inhibit ataxia telangiectasia and Rad3-related protein (ATR). ATR is believed to be a key sensor for DNA damage, activating the DNA damage checkpoint and leading to cell cycle arrest. Inhibition of ATR could potentially enhance the efficacy of DNA-damaging agents, but is also being investigated as a monotherapy against tumors with high levels of replication stress induced by overexpression of oncogenes.

About M3814 

M3814 is an investigational small-molecule which is thought to inhibit DNA-dependent protein kinase (DNA-PK). DNA-PK is a key enzyme for non-homologous end-joining (NHEJ), an important DNA double-strand break (DSB) repair pathway. Clinical studies investigating combinations of M3814 with other commonly used DNA-damaging agents such as radiotherapy and chemotherapy are underway.

About M7583 

M7583 is an investigational therapy that is thought to be a highly selective covalent inhibitor of Bruton’s tyrosine kinase (BTKi) designed to minimize off-target effects.

About Abituzumab  

Abituzumab is an investigational pan-αν integrin inhibiting monoclonal antibody thought to show activity against αvβ1, 3, 5, 6 and 8 integrin heterodimers. Merck entered into a development agreement with the SFJ Pharmaceuticals Group for abituzumab in metastatic colorectal cancer (mCRC). This collaboration will allow Merck and SFJ to develop the potential of abituzumab in a targeted way, focusing on a patient population that may benefit from the treatment the most.

About Erbitux^® (cetuximab)  

Erbitux^® is a IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, Erbitux also targets cytotoxic immune effector cells towards EGFR expressing tumor cells (antibody dependent cell-mediated cytotoxicity, ADCC).

The most commonly reported side effect with Erbitux is an acne-like skin rash. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in over 100 countries world-wide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right to market Erbitux, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998.

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About Merck 

Merck is a leading science and technology company in healthcare, life science and performance materials. Almost 53,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2017, Merck generated sales of € 15.3 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

References 

1. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of cancer immunotherapy. Cancer Control 2014;21:231-7.
2. Dahan R et al. FcγRs modulate the anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis. Cancer Cell 2015;28:285-95.
3. Boyerinas B et al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res 2015;3:1148-57.
4. Kohrt HE et al. Combination strategies to enhance antitumor ADCC. Immunotherapy 2012;4:511-27.
5. Hamilton G, Rath B. Avelumab: combining immune checkpoint inhibition and antibody-dependent cytotoxicity. Expert Opin Biol Ther 2017;17:515-23.

JAKARTA, Indonesia, Oct. 9, 2018 /PRNewswire/ — According to the report of BNPB (National Disaster Management Agency), the number of death toll because of recent earthquakes and tsunami in Central Sulawesi has reached 1,424 people. That number consists of 1,203 death tolls in Palu, 144 death tolls in Donggala, 64 death tolls in Sigi, 12 death tolls in Parigi Moutong, and 1 death toll in Pasangkayu. The death toll reached 3 times more than that in recent Lombok’s earthquakes. BNPB report on October 5th showed the death toll has reached 1,558 people and will rise sharply due to high number of victims who have not been evacuated from the ruins of building or who were trapped in the mud.

The areas affected by the earthquake and tsunami disaster in Palu were more than 350 ha, of which those officially released by BNPB and Lapan were 180 ha in Petobo, 202 ha in Jono Oge, and 47.8 ha in Balaroa. The current situation of the three regions concerns the world since those residential areas considered ‘lost’ due to the earthquake and tsunami mud sweep. The breadth of the area damaged by the disaster caused the affected victims escaping to other areas, such as Mamuju Regency. Recorded up until October 5th 2018, Mamuju Regency received 4,257 refugees.

The damaged facilities and infrastructures due to the disaster’s devastation in Central Sulawesi made it hard to access electricity, clean water, sanitation, food, and other basic life needs, as well as the proper refugee camps. Those conditions might lead to the spreading of infectious diseases. Various studies about diseases caused by natural disasters indicate that the diseases’ clinical phase, which number of diseases are spreading high in a disaster, is at the disaster’s post-impact phase and recovery phase.

Basically, a disaster has 3 phases, namely the impact phase (1-4 days), the post-impact phase (4 days to 1 month), and the recovery phase (more than 1 month). In the post-impact phase, infectious diseases that are easy to spread are diseases caused by air, water and food. Those spreading supported by the bad condition of refugees’ camp. Meanwhile, during the disaster recovery phase, infections with a long incubation period begin to appear its clinical symptoms. In this phase, diseases which become endemic in an area could become epidemics due to displacement of refugees from one region to another.

According to various studies, diarrheal diseases account for as much as 40% of deaths at disaster sites and evacuation sites. The spread of diarrhea is related to contaminated water sources, water contamination during transportation and storage, use of shared cooking utensils, lack of soap, and contaminated food. In the 2004 Aceh tsunami, 85% of refugees in Calang City experienced diarrhea after drinking water from contaminated wells (Brennan & Kimba, 2006).

The study of Isidore et al (2014), a literature study from various post-disaster disease case report studies, shows that other infectious diseases which also infect refugees are leptospirosis, cholera, hepatitis A and E, acute respiratory infections, measles, meningitis, TB, malaria, dengue fever, tetanus, and Cutaneous mucormycosis fungal infection. The spread of influenza diseases such as H1N1 or commonly known as swine flu was also noted to develop very quickly with high mortality just after the devastating earthquake that shook East Japan in 2011.

Acute respiratory infection was the most common diseases causing deaths among refugees in Banda Aceh due to the 2004 tsunami. The risk of acute respiratory infections would increase in consequences of overcrowded conditions, poor ventilation, poor nutrition and cold weather. In addition, measles and meningitis were also reported to infect many refugees in Banda Aceh. Overcrowding refugees camp, poor hygiene, and difficult access to health care facilities and staying close to infected people are the main risk factors associated with the spread of these two diseases. The spread of tetanus was also reported to occur during the post-impact and recovery phases in Aceh tsunami. The spread was caused by open wound infections and populations who are not well-vaccinated.

Beyond the high number of death toll and the destruction of more than 65,000 buildings, the earthquake and tsunami that occurred in Central Sulawesi also affected fisheries, agriculture and livestock. Animals that die from disasters would increase the risk of zoonotic diseases exposure in human, such as anthrax, rabies, leptospirosis and others. In the same study, Isidore et al also noted that there were leptospirosis outbreaks in several disasters which occurred around the world, such as storms in Taiwan and China, and floods in Thailand and India.

General Directorate of Infection Prevention and Control, Ministry of Health Republic of Indonesia dr. Anung Sugiantono stated that Palu, Donggala and regions around them are malaria endemic areas. Environmental changes after the earthquake and tsunami will facilitate the spread of diseases carried by the Anopheles mosquito. For this reason, One Health approach is needed to prevent the expansion of malaria endemic in Palu and its surroundings.

One Health is a collaborative effort of multi-professions and health institutions which work locally, nationally and globally in achieving optimal health through the prevention and mitigation of adverse impacts due to animal, human and environmental interactions. This means that doctors, veterinarians, nurses, pharmacists, dentists, epidemiologists, and health institutions and other related institutions collaborate in addressing health issues. The One Health approach considers the role of changing environment with regard to the risk of infectious and chronic diseases affecting humans and animals.

Based on the situation, Prof. Wiku Adisasmito as INDOHUN (Indonesia One Health University Network) coordinator conveyed the importance of implementing One Health concept as an effective effort which could be applied in preventing the spread of post-disaster infectious diseases. “One Health concept developed by multi-disciplinary science and integrated cross-sector could prevent outbreaks of post-disaster diseases, especially the transmission of diseases between humans, animals and the environment.”

The step which should be taken by the government is establishing coordination between local city/regency offices and provincial agencies, also with the national level agencies to produce a comprehensive handling strategy. One example of a program which could be accomplished with multi-sectoral cooperation is a refugee shelter program that meets the standards.

Refugee shelter such as tents or barracks should be in proper condition, thus it would not increase the number of deaths caused by infectious diseases. The proper conditions for refugees’ camp are indicated by the availability of clean water and adequate sanitation facilities, as well as sufficient food. Health workers or volunteers are also expected to fulfill the qualifications in order to provide the best care supported by adequate amounts and types of drugs. Minimum standards of health services in refugees camp according to the Ministry of Health are public health services, reproductive health services, and mental health services. Prevention and eradication of infectious diseases also need to be done by conducting surveillance, vaccination, and case management of disease.

Photo – https://photos.prnasia.com/prnh/20181009/2262032-1