News Article | May 9, 2017
Q1 2017 marked by positive data from Phase 2 study of anabasum for the treatment of cystic fibrosis Company ended the quarter with $49 million of cash which is sufficient to fund operations through the end of 2018 NORWOOD, MA--(Marketwired - May 09, 2017) - Corbus Pharmaceuticals Holdings, Inc. ( : CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today its financial results for the first quarter ended March 31, 2017. The Company also provided an update to its corporate progress, clinical status and anticipated milestones for anabasum, its novel synthetic oral endocannabinoid-mimetic drug that is designed to resolve chronic inflammation and halt fibrosis. "We have made significant progress in both the corporate and clinical areas in the first quarter of 2017 and are in a strong financial position, which is expected to take us through key milestones for the Company over the next 20 months," stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company. Corbus reported positive topline data results from a Phase 2 study in diffuse cutaneous systemic sclerosis ("systemic sclerosis") in November 2016, showing a clear signal of clinical benefit with anabasum. The 12-month open-label extension of this Phase 2 study is ongoing and is designed to capture long-term safety and efficacy data in subjects dosed with anabasum 20 mg twice per day. To date, subjects have been safely dosed with anabasum for up to 10 months and Corbus intends to present data at the 2017 American College of Rheumatology ("ACR") Annual Meeting. Following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA"), Corbus submitted a protocol to the FDA for its Phase 3 study in systemic sclerosis on March 31, 2017, and is moving forward as planned. The Company expects to commence this study in the fourth quarter of 2017. Protocol assistance from the European Medicines Agency ("EMA") on the Phase 3 study design is expected in the second quarter of 2017. The planned Phase 3 study is a double-blind, randomized, placebo-controlled, parallel dose, multi-center study to be conducted in approximately 270 adults with diffuse cutaneous systemic sclerosis. Subjects will be randomized to receive anabasum 20 mg twice per day, anabasum 5 mg twice per day, or placebo twice per day for 52 weeks. The primary efficacy outcome of the planned Phase 3 study will be change from baseline at Week 52 in modified Rodnan Skin Score ("mRSS"), a measure of skin thickening and a validated clinical outcome measure in systemic sclerosis. Topline results of the Phase 2 study showed that the mean improvement from baseline in mRSS for anabasum-treated subjects was greater than for the placebo-treated subjects, and considered medically meaningful. The improvement in mRSS was accompanied by statistically significant improvement in the anabasum arm in patient-reported skin symptoms and reduced expression of genes associated with inflammation and fibrosis in skin biopsies. Corbus expects to complete enrollment of the 52-week study in 2018. The Company also expects results by the end of 2019 and a New Drug Application ("NDA") application to be filed in 2020. Anabasum was granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis from the FDA in 2015 and Orphan Designation from the European Medicines Agency ("EMA") in January 2017. The Company was not granted Breakthrough Designation for systemic sclerosis, however Corbus' existing Fast Track status already grants it similar eligibility for more frequent meetings with the FDA to discuss the development plan for anabasum, as well as Priority Review and Rolling Reviews of completed sections of the NDA. In March 2017, Corbus reported positive topline data from the double-blind, randomized, placebo-controlled Phase 2 study of anabasum for the treatment of cystic fibrosis ("CF") showing that anabasum had an acceptable safety and tolerability profile, reduced pulmonary exacerbations treated with antibiotics, and reduced multiple inflammatory biomarkers in sputum collected from subjects in the study. The 16-week study was an international, multi-center study supported by a $5 million Development Award from Cystic Fibrosis Foundation Therapeutics, Inc. Anabasum successfully achieved the primary objective of the study by demonstrating an acceptable safety and tolerability profile with no serious or severe adverse events related to the study drug. Anabasum cohorts showed a reduction in a number (event rate per subject) of pulmonary exacerbations treated with intravenous antibiotics compared to placebo, which was a prespecified event of special interest in the protocol, as well as the number (event rate per subject) of pulmonary exacerbations treated with any new antibiotic. Patients in the highest dose cohort of anabasum (20 mg orally, twice per day) had a 75% reduction in the annualized rate of pulmonary exacerbations requiring IV antibiotics compared to placebo cohort. Forced expiratory volume in 1 second (FEV1) remained stable throughout the study in all treatment cohorts. Additionally, patients receiving anabasum showed a reduction in multiple inflammatory cell types in sputum, including total leukocytes, neutrophils, eosinophils, and macrophages. Also, a dose-dependent reduction in sputum inflammatory mediators, including interleukin-8, neutrophil elastase, and immunoglobulin G was observed. These data provide evidence of pharmacologic activity of anabasum at resolving ongoing innate immune responses in lungs of CF patients and support the potential of anabasum to reduce in pulmonary exacerbations in CF. Anabasum was granted Orphan Drug Designation and Fast Track status for the treatment of CF by the FDA in 2015 and Orphan Designation from the EMA in 2016. Corbus is currently evaluating anabasum in an on-going Phase 2 study for the treatment of skin-predominant dermatomyositis. In November 2016, the Company commenced a one-year, open-label extension to provide all enrolled subjects in the Phase 2 study with the option of receiving anabasum for one year after they complete the four-month, double-blind placebo controlled portion of the study. The Phase 2 study in skin-predominant dermatomyositis is being funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health to the University of Pennsylvania School of Medicine. For more information on the Phase 2 study with anabasum for the treatment of skin-predominant dermatomyositis, please visit ClinicalTrials.gov and reference Identifier NCT02466243. Corbus expects the National Institutes of Health ("NIH")-funded and operationally-executed Phase 2 clinical study evaluating anabasum for the treatment of systemic lupus erythematosus ("SLE") to begin in the second half of 2017. The Phase 2 SLE study will evaluate anabasum at doses of 5 mg, 20 mg, and 20 mg twice daily, administered orally for 12 weeks, with 1 month follow-up, at approximately 12 U.S. sites. "We are very pleased with our progress in the clinical development of anabasum over the past two years, advancing this experimental drug into multiple first-in-patient studies in serious chronic indications with high unmet medical needs, two of which have delivered positive clinical data and are moving ahead to their next stages of clinical development by year end," concluded Dr. Cohen. Summary of Financial Results for First Quarter 2017 For the quarter ended March 31, 2017, the Company reported a net loss of approximately $7,465,000, or a net loss per diluted share of $0.16, compared to a net loss of approximately $2,892,000, or a net loss per diluted share of $0.08 for the quarter ended March 31, 2016. Collaboration revenue for the quarter increased by approximately $0.9 million to $1.3 million due to revenue recognized from the $5 million development award received from the Cystic Fibrosis Foundation Therapeutics, Inc. Operating expenses increased by approximately $5.4 million to $8.7 million due to increased spending for clinical studies, manufacturing costs to produce anabasum for clinical studies and staffing costs. The Company ended the first quarter with $48.9 million of cash and cash equivalents, an increase of $33.9 million from the start of the quarter. The Company raised $41 million of capital during the first quarter including the following: The Company expects the cash on hand to fund operations through the fourth quarter of 2018, based on current planned expenditures. Anabasum is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Preclinical and human clinical studies have shown anabasum to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in preclinical models of inflammation and fibrosis. Anabasum is designed to trigger the production of "Specialized Pro-resolving Lipid Mediators" that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of multiple inflammatory mediators. Anabasum also is designed to have direct effects on fibroblasts to halt tissue scarring. In effect, anabasum triggers endogenous pathways to turn "off" chronic inflammation and fibrotic processes, without causing immunosuppression. Corbus Pharmaceuticals Holdings, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. Our lead product candidate, anabasum, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation, and fibrotic processes. Anabasum is currently in development for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis, skin-predominant dermatomyositis, and systemic lupus erythematosus. For more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, Google+ and Facebook. This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
News Article | May 9, 2017
CrowdReviews.com Partnered with Madridge Conferences to Announce International Conference on Immunology and Immunotechnology Immunology-2017 features highly enlightening and interactive sessions to encourage the exchange of ideas across a wide range of disciplines in the field of immunology. Immunology-2017 mainly showcases comprehensive approaches in immunology study and research. The field of Immunology is growing rapidly and its development is making tremendous impacts in medical sciences. Immunology-2017 invites the contributions related to immunology research. You can submit your work in these broad themes. Conference mainly focuses on: Clinical and cellular immunology Tumour and cancer immunology Neuro immunology Parasitology Autoimmunity and Therapathies Mucosal immunology Reproductive Immunology Immunobiology Infection & Inflammatory Disease Rheumatology Haematopoiesis Transplantation Immunology Virology Immunodermatology Molecular and Structural Immunology Veterinary Immunology and Immunopathology Allergology and Immunology All the abstracts should be submitted through Immunology-2017 Speakers: · Nadir Kadri, Karolinska Institute, Sweden · Pawel Gajdanowicz, Wroclaw Medical University, Poland · Joel Babdor, Stanford University School of Medicine, USA · Kwan Chow, Washington University, USA · Abdallah Badou, Cadi Ayyad University, Morocco Immunology-2017 Organizing Committee: · Carmen Fernández , Stockholm University, Sweden · Carl Borrebaeck, Lund University, Sweden · SY Seong, Seoul National University College of Medicine, South Korea · Shi, Guo-Ping, Brigham and Women's Hospital, USA · Gideon Berke, Weizmann Institute of Science, Isreal · Eyad Elkord, United Arab Emirates University, United ArabEmirates · Noah Isakov, Ben Gurion University of the Negev, Isreal · Joel Pomerantz, The Johns Hopkins University School of Medicine, USA · NanShan Chang, Institute of Molecular Medicine, Taiwan · Hisaya Akiba, Juntendo University School of Medicine, Japan · Ricardo Luiz Dantas Machado, Evandro Chagas Institute, Brazil Immunology-2017 is organizing an outstanding Scientific Exhibition/Program and anticipates the world’s leading specialists involved in Immunology Research. They welcome Sponsorship and Exhibitions from the Companies and Organizations who wish to showcase their products at this exciting event. Register for the conference and book your slots at: Contact person: Sumanjani firstname.lastname@example.org email@example.com Naples, FL, May 09, 2017 --( PR.com )-- International Conference Immunology and Immunotechnology is going to be held during November 1-3, 2017 in Barcelona, Spain.Immunology-2017 features highly enlightening and interactive sessions to encourage the exchange of ideas across a wide range of disciplines in the field of immunology. Immunology-2017 mainly showcases comprehensive approaches in immunology study and research. The field of Immunology is growing rapidly and its development is making tremendous impacts in medical sciences.Immunology-2017 invites the contributions related to immunology research. You can submit your work in these broad themes.Conference mainly focuses on:Clinical and cellular immunologyTumour and cancer immunologyNeuro immunologyParasitologyAutoimmunity and TherapathiesMucosal immunologyReproductive ImmunologyImmunobiologyInfection & Inflammatory DiseaseRheumatologyHaematopoiesisTransplantation ImmunologyVirologyImmunodermatologyMolecular and Structural ImmunologyVeterinary Immunology and ImmunopathologyAllergology and ImmunologyAll the abstracts should be submitted through online abstract submission or can be mailed at firstname.lastname@example.org Immunology-2017 Speakers:· Nadir Kadri, Karolinska Institute, Sweden· Pawel Gajdanowicz, Wroclaw Medical University, Poland· Joel Babdor, Stanford University School of Medicine, USA· Kwan Chow, Washington University, USA· Abdallah Badou, Cadi Ayyad University, MoroccoImmunology-2017 Organizing Committee:· Carmen Fernández , Stockholm University, Sweden· Carl Borrebaeck, Lund University, Sweden· SY Seong, Seoul National University College of Medicine, South Korea· Shi, Guo-Ping, Brigham and Women's Hospital, USA· Gideon Berke, Weizmann Institute of Science, Isreal· Eyad Elkord, United Arab Emirates University, United ArabEmirates· Noah Isakov, Ben Gurion University of the Negev, Isreal· Joel Pomerantz, The Johns Hopkins University School of Medicine, USA· NanShan Chang, Institute of Molecular Medicine, Taiwan· Hisaya Akiba, Juntendo University School of Medicine, Japan· Ricardo Luiz Dantas Machado, Evandro Chagas Institute, BrazilImmunology-2017 is organizing an outstanding Scientific Exhibition/Program and anticipates the world’s leading specialists involved in Immunology Research. They welcome Sponsorship and Exhibitions from the Companies and Organizations who wish to showcase their products at this exciting event.Register for the conference and book your slots at: http://immunology.madridge.com/register.php Contact person:Sumanjani
News Article | May 13, 2017
Role Tea, a new line of bottled wellness iced teas that blends anti-inflammatory ingredients like turmeric, cinnamon and ginger with brewed teas and juices has officially launched in the Mid-Atlantic Whole Foods region. Just five months since launching, Role Tea has already began selling in select Whole Foods in DC, Northern Virginia and Maryland this week. They expect to be up and running in 15 to 25 Whole Foods locations in the region by Mid-June. To understand the appeal of Role Tea, look no further than the brand’s focal ingredient, turmeric. The ancient spice popular in Asian cuisine has grown in popularity in the United States in recent years. This is due to its anti-inflammatory properties and wellness benefits. “Consumers are looking for better for you alternatives to beverages they drink regularly without compromising taste. Few ingredients cover the 'better for you' part of that equation like turmeric.” Mike Johnson, the company’s CEO/Co-Founder stated. Role Tea will be Whole Food’s only turmeric-based beverage to retail under $3 per bottle. This helps uniquely position the brand to make a strong run in the highly competitive, ready-to-drink tea category valued at $5.8 billion in the United States*. "Whole Foods continues to be a great partner for young brands like Role Tea. We're excited for the opportunity to work with them," Johnson added. Role Tea started when Johnson tried to find an on-the-go beverage that may help fight inflammation. What he found were mostly juices high in sugar and priced above $5 per bottle. When Johnson considered launching a beverage of his own, he reached out to partner with Koray Benson, the company’s COO/Co-Founder. Johnson and Benson met as members of an Executive Leadership Development program in 2012 prior to pairing up to develop Role Tea in early 2016. It took the pair over 60 iterations to land on the brand's three flavors (they call "blends"). The three distinct blends span from a 10 calorie, no sugar or sweetener added option to two options sweetened with cane sugar or honey. Every blend contains 400mg of either water-soluble turmeric or cinnamon extract to help support a better inflammation response in the body. Role Tea is sold in 12 oz. recyclable plastic bottles and consist only of 100% natural ingredients. The products are also vegan, gluten-free and non-GMO. “We’ve come to learn a lot about the benefits of incorporating more anti-inflammatory foods into our diets. Inflammation related ailments are a real issue that we hope to build awareness of through our products and community involvement.” Johnson stated. Role Tea recently served as one of the first ever non-pharmaceutical product sponsors at Howard University’s 12th Annual Rheumatology Symposium. Role Tea also been product sponsors for the DC/NOVA chapter of the Crohn’s and Colitis Foundation and contributor to the National Ovarian Cancer Coalition. Role Tea focused on testing the product in select independent grocery, fast-casual restaurants and gas/convenience locations to better understand their core customer before approaching Whole Foods. “Our customers are more moderation minded. They want to make healthier choices but they don't want to compromise taste to get it. They love how Role Tea gives them meaningful amounts of purposeful ingredients like turmeric or cinnamon with just the right level of flavor. It's something we're confident Whole Foods consumers will appreciate as well.” Benson stated. To learn more about Role Tea and how to purchase, please visit their website at https://www.drinkroletea.com.
News Article | May 11, 2017
WATERTOWN, Mass., May 11, 2017 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses, today reported financial results for the first quarter ended March 31, 2017 and provided a corporate update. “Selecta continues to make great strides in 2017,” said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. “Enrollment in the Phase 2 trial of our lead product candidate, SEL-212, continues to be faster than anticipated, and we remain on track to complete the trial in 2017. In addition, we recently added a clinical-stage oncology product candidate, LMB-100, to our proprietary pipeline and plan to combine it with SVP-Rapamycin in a clinical program for mesothelioma and pancreatic cancer with our collaborators at NCI. We also obtained a key license for our MMA gene therapy program, and we began dosing patients in a Phase 1 trial of our nicotine vaccine candidate for smoking cessation and relapse prevention. These programs highlight the far-reaching potential of our Synthetic Vaccine Particles (SVP™) technology platform and the strong execution of the Selecta team.” In the fourth quarter of 2016, Selecta began enrolling patients with symptomatic gout and elevated serum uric acid levels (above 6.0 mg/dL) in an open-label, multiple ascending dose Phase 2 clinical trial of SEL-212 (SVP-Rapamycin in combination with pegsiticase). The primary and secondary endpoints for this trial include safety, tolerability, pharmacokinetics, reduction of serum uric acid levels and reduction of ADA levels. Data also are being collected regarding flares and additional laboratory and clinical assessments. Patients are being enrolled in multiple ascending dose cohorts to enable the identification of the optimal dose ratio of SVP-Rapamycin and pegsiticase, the minimal effective dose level of SEL-212 for repeat monthly administration, and the dose regimen to take forward into Phase 3. As of May 10, 2017, a total of 58 patients had been dosed in the Phase 2 trial in eight cohorts. During the week of June 12, 2017, Selecta is presenting at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid, Spain and at the Federation of Clinical Immunology Societies Annual Meeting (FOCIS 2017) in Chicago and plans to report additional data from the ongoing Phase 2 trial at that time. The company expects that it will complete the trial in 2017 and initiate its Phase 3 program in 2018. Selecta management will host a conference call at 5:00 p.m. ET today to provide a corporate update and review the company’s first quarter financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, http://selectabio.com. Individuals may also participate in the call via telephone by dialing (877) 270-2148 (domestic) or (412) 902-6510 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10106207. Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP™) to a range of biologics for rare and serious diseases that require new treatment options. The company’s current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company’s lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter. Forward-Looking Statements Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, statements regarding the progress of the Phase 1/2 clinical program of SEL-212 including the pace of enrollment, the potential of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, whether the Phase 2 of SEL-212 will be completed in 2017 and whether the Phase 3 trial will be initiated in 2018,the company’s ability to unlock the full potential of biologic therapies, the potential applications for products utilizing the SVP platform in areas such as enzyme therapy, gene therapy, oncology therapy, vaccines and treatments for allergies and autoimmune diseases, whether the combination of LMB-100 and SVP-Rapamycin may allow patients to avoid antibody responses and benefit from a full treatment of LMB-100, whether Selecta and NCI initiate a Phase 1b clinical trial of the LMB-100 and SVP-Rapamycin combination, the potential of the company’s two gene therapy product candidates to enable repeat administration, the progress of the company’s Phase I clinical trial in SELA-070, statements regarding the ability of SELA-070 to achieve smoking cessation and relapse prevention, statements regarding SELA-070’s ability to produce a high level of anti-nicotine antibodies and ultimately prevent nicotine from crossing the blood-brain barrier, the sufficiency of the company’s cash, cash equivalents, investments, and restricted cash and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the unproven approach of the company’s SVP technology, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, substantial fluctuation in the price of its common stock, a significant portion of the company’s total outstanding shares have recently become eligible to be sold into the market, and other important factors discussed in the “Risk Factors” section of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 28, 2017, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.
News Article | May 12, 2017
INCHEON, South Korea--(BUSINESS WIRE)--Detailed results from NOR-SWITCH, a randomized, double-blind, switching study of biosimilar infliximab, CT-P13 (Remsima®/ Inflectra™) were published in the prestigious journal The Lancet. Sponsored by the Norwegian government, the study explored the impact of switching adult patients who were stable on reference infliximab to Celltrion Healthcare’s biosimilar CT-P13. The results demonstrate that CT-P13 is not inferior to continued treatment with the reference product and that patients can be safely switched. 1 Dr Kwon, Medical Director at Celltrion Healthcare said: “ The publication of the NOR-SWITCH data in The Lancet marks another important milestone on the path to increasing physician confidence in using biosimilar infliximab when looking to switch their patients.” Following presentations at both the 2016 United European Gastroenterology (UEG) Week and the American College of Rheumatology (ACR) Annual Meeting, the findings from the study revealed that out of the 50% of patients switched to CT-P13, the proportion of patients with disease worsening were comparable to those who remained on reference infliximab (29.6 and 26.2% respectively.) The data discontinuation rates due to a lack of efficacy for reference infliximab and biosimilar infliximab were eight and three respectively. The time to study drug discontinuation was almost identical between the two groups, with similar overall remission rates and frequencies of adverse events also observed. 1 Tore K. Kvien, Head of Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, and the lead author of the NOR-SWITCH study, also said: “ NOR-SWITCH results show that efficacy and safety were comparable between patients switched to CT-P13 and those who continued treatment with reference infliximab, proving that patients can be safely switched to CT-P13. As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.” The Norwegian government wanted to determine the impact of switching adult patients who were stable on reference infliximab to biosimilar (CT-P13), and funded NOR-SWITCH to evaluate this across all inflammatory diseases for which infliximab is approved (Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis). Involving nearly 500 patients, the study was designed by a multidisciplinary and multiregional project group with special competence in performance of strategy trials, immunogenicity, and statistics led by Professor Tore Kvien at the Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. Additionally, the group consisted of representatives from the three relevant patient organisations.2 CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe. Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ The Lancet is one of the world's leading independent general medical journal. The peer-reviewed journal publishes medical news, original research, and reviews on all aspects of clinical medicine and International Health. The Lancet has an Impact Factor of 44.002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Available at: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [accessed May 2017]. 2 GAFPA. NOR-SWITCH. Available at: http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2016/09/GAfPA_Norswitch_Sept.-2016.pdf [accessed May 2017].
News Article | May 12, 2017
Dr Kwon, medisch directeur bij Celltrion Healthcare, verklaarde: “ De publicatie van de NOR-SWITCH-gegevens in The Lancet markeert opnieuw een belangrijke mijlpaal voor het vergroten van het vertrouwen van artsen om biosimilar infliximab te gebruiken als overwogen wordt om hun patiënten over te schakelen.” Na presentaties tijdens zowel de 2016 United European Gastroenterology (UEG) Week als de jaarlijkse bijeenkomst van het American College of Rheumatology (ACR) bleek uit de bevindingen van de studie dat van de 50% van de patiënten die overgeschakeld waren naar CT-P13, het percentage patiënten met verslechtering van de ziekte vergelijkbaar was met die patiënten die referentie infliximab bleven gebruiken (respectievelijk 29,6 en 26,2%). De datadiscontinueringspercentages door een gebrek aan werkzaamheid voor referentie infliximab en biosimilar infliximab waren respectievelijk acht en drie. De tijd om de stopzetting van de medicijnen te onderzoeken was bijna identiek tussen de twee groepen, waarbij ook vergelijkbare totale remissiecijfers en frequenties van bijwerkingen waargenomen werden. 1 CP-P13 is ontwikkeld en geproduceerd door Celltrion, Inc. en was 's werelds eerste monoklonaal antilichaam-biosimilar dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september 2013 door de EMA goedgekeurd onder de handelsnaam Remsima® goedgekeurd en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's CT-P13 goed in april 2016 onder de handelsnaam Inflectra™. Celltrion's CT-P13 is goedgekeurd in meer dan 79 (vanaf januari 2017) landen, waaronder de VS, Canada, Japan en heel Europa. Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ The Lancet is een van 's werelds grootste onafhankelijke algemene medische tijdschriften. Het intercollegiaal getoetste tijdschrift publiceert medisch nieuws en origineel onderzoek en biedt evaluaties over alle aspecten van klinische geneeskunde en internationale gezondheid. The Lancet heeft een impactfactor van 44,002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, beschikbaar op: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [geraadpleegd in mei 2017]. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.
News Article | May 12, 2017
Sponsorizzato dal governo norvegese, lo studio ha esplorato l’impatto del passaggio al biosimilare infliximab CT-P13 di Celltrion Healthcare nei pazienti adulti in condizioni stabili trattati con il prodotto originale infliximab. I dati dimostrano che CT-P13 non è inferiore al trattamento continuativo con infliximab originale e che i pazienti possono passare da una terapia all'altra in tutta sicurezza. 1 A seguito di presentazioni tenutesi in occasione della 2016 United European Gastroenterology (UEG) Week e dell’incontro annuale dell’American College of Rheumatology (ACR), i dati dello studio hanno rivelato che nel 50% di pazienti passati a CT-P13, la proporzione di pazienti che hanno dimostrato un peggioramento della malattia era paragonabile a quelli che continuavano ad essere trattati con infliximab originale (29,6 e 26,2%, rispettivamente). I tassi di sospensione dei dati dovuta ad una mancanza di efficacia per infliximab orginale e infliximab biosimilare erano pari a otto e tre, rispettivamente. È risultato inoltre che il tempo necessario per studiare la sospensione del farmaco sperimentale era quasi identico per entrambi i gruppi, con simili tassi di remissione e frequenza di eventi avversi complessivi. 1 Il Professor Tore Kvien, responsabile del dipartimento di reumatologia del Diakonhjemmet Hospital di Oslo, in Norvegia, e responsabile dello studio NOR-SWITCH, ha inoltre dichiarato: “ I risultati di NOR-SWITCH mostrano che la sicurezza e l’efficacia erano paragonabili fra pazienti che sono passati a CT-P13 e quelli che continuavano il trattamento con infliximab originale, provando che i pazienti possono passare a CT-P13 in tutta sicurezza. Va tuttavia ricordato che questi dati si riferiscono specificamente a CT-P13 e non sono trasferibili ad altri biosimilari”. Per determinare l’impatto del passaggio al biosimilare infliximab (CT-P13) nei pazienti adulti in condizioni stabili precedentemente trattati con il prodotto originale, il governo norvegese ha finanziato lo studio NOR-SWITCH per valutare questa opzione in tutte le patologie infiammatorie per le quali infliximab è approvato (morbo di Crohn, colite ulcerativa, artrite reumatoide, spondiloartrite, artrite psoriasica o psoriasi cronica a placche). CT-P13, sviluppato e prodotto da Celltrion, Inc., è stato il primo anticorpo monoclonale biosimilare approvato dall'Agenzia europea per i medicinali (EMA). È indicato per il trattamento di otto malattie autoimmuni, inclusa l'artrite reumatoide e le malattie infiammatorie intestinali. Ha ricevuto l'approvazione dell'EMA con il nome commerciale Remsima® nel mese di settembre del 2013 ed è stato lanciato in Europa agli inizi del 2015. La FDA statunitense ha approvato CT-P13 di Celltron nel mese di aprile 2016 con il nome commerciale Inflectra™. CT-P13 di Celltron è approvato in oltre 79 paesi (dati aggiornati al mese di gennaio 2017) inclusi Stati Uniti, Canada, Giappone e tutta l'Europa. Celltrion Healthcare effettua a livello mondiale attività di marketing, vendita e distribuzione dei biofarmaci sviluppati da Celltrion, Inc. tramite un'estesa rete internazionale che comprende più di 120 paesi diversi. I prodotti di Celltrion Healthcare sono realizzati a partire da colture cellulari di mammiferi in avanzate strutture studiate e realizzate per la conformità agli standard cGMP della FDA statunitense e agli standard GMP della UE. Per ulteriori informazioni visitare il sito http://www.celltrionhealthcare.com/ 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Disponibile su: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [ultimo accesso maggio 2017].
News Article | May 9, 2017
The results of a study led by Massachusetts General Hospital (MGH) investigators suggest that following a diet known to reduce the risk of hypertension and cardiovascular disease may also reduce the risk of gout. The team's analysis of more than 25 years of data, published in The BMJ, found a significantly lower incidence of gout in men with dietary patterns similar to those of the DASH diet - which emphasizes increased consumption of fruits, vegetables and low-fat dairy products - while those following a more typical Western diet showed an increased risk of developing gout. "The current dietary recommendation for gout care is a diet low in purines, which are found in certain meats and seafood, but following such a diet has limited effectiveness and proves challenging for many patients," says Hyon Choi, MD, DrPH, director of the Gout and Crystal Arthropathy Center in the MGH Division of Rheumatology, Allergy, and Immunology, senior author of the report. "This kind of low-protein diet may also promote increased consumption of refined carbohydrates and unhealthy fats - including trans fats - that can worsen cardiovascular and metabolic problems common in gout patients." Caused by a build-up of uric acid crystals in joints, gout is the most common inflammatory arthritis, and its prevalence in the U.S. and U.K. has increased in recent decades. The DASH (Dietary Approaches to Stop Hypertension) diet emphasizes the consumption of fruits, vegetables, low-fat dairy items, whole grains, poultry, fish and nuts, while discouraging eating foods high in saturated fats, cholesterol, trans fats and sodium, as well as red meats and sweets. The diet is designed to be flexible and balanced, and several studies have confirmed its ability to reduce risks for hypertension and cardiovascular disease. A recent analysis of data from a clinical trial of the diet showed it also reduced uric acid in participants with elevated levels in their blood. For the current study, the research team analyzed data from the Health Professionals Follow-up Study, which has followed more than 50,000 male health professionals who were ages 40 to 75 when the study began in 1986. Every two years participants provide information on their current weight, medication use and medical conditions for which they have been diagnosed. Every four years they complete detailed questionnaires on their diets - including how frequently they consume various types of food. Participants were not assigned any particular diet as part of either the current investigation or the overall Health Professionals Follow-up Study. In their analysis of information provided by 44,444 participants who had no history of gout prior to joining the study, the research team applied two scoring systems to each participant's reported intake. The DASH score was increased for consumption of fruits, vegetables, nuts and legumes, low-fat dairy products and whole grains but decreased for consumption of red or processed meats, sodium and sweetened beverages. The Western dietary pattern score reflected intake of red and processed meats, sugar-sweetened beverages, sweets, desserts, French fries and refined grains. During the 26-year study period - from 1986 to 2012 - 1,731 participants were newly diagnosed with gout. Individuals with a higher DASH score were less likely to be diagnosed with gout, while the risk was increased in those with an elevated Western diet score. Controlling for other gout risk factors - such as age, weight, hypertension, kidney failure and intake of alcohol or coffee - did not alter the associations. While these findings need to be confirmed in future interventional trials, the researchers note that many individuals at risk for gout because of elevated uric acid levels might already be candidates for the DASH diets, since more than half of such individuals also have hypertension. The only group that probably should be careful with the DASH diet would be patients with severe kidney disease, since the diet can be high in potassium. "For individuals at high risk for gout, especially those who also have hypertension, the DASH diet is likely to be an ideal preventive approach," says Sharan Rai, MSc, of the MGH Division of Rheumatology, Allergy, and Immunology, lead author of the BMJ paper. "The diet may also be a good option for patients with gout who have not reached a stage requiring urate-lowering drugs or those who prefer to avoid taking drugs. And since the vast majority of patients with gout also have hypertension, following the DASH diet has the potential of 'killing two birds with one stone,' addressing both conditions together." Additional co-authors of the BMJ paper are Na Lu, MPH, and Sarah Keller, MD, MGH Division of Rheumatology, Allergy, and Immunology; Teresa Fung, ScD, RD, Harvard T.H. Chan School of Public Health; and Gary Curhan, MD, ScD, Brigham and Women's Hospital. Choi is a professor of Medicine at Harvard Medical School. The study was supported by National Institutes of Health grants R01AR065944 and UM1CA167552. Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $800 million and major research centers in HIV/AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, genomic medicine, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, photomedicine and transplantation biology. The MGH topped the 2015 Nature Index list of health care organizations publishing in leading scientific journals and earned the prestigious 2015 Foster G. McGaw Prize for Excellence in Community Service. In August 2016 the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America's Best Hospitals.