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News Article | May 18, 2017
Site: www.marketwired.com

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. Pediapharm Inc. ("Pediapharm" or the "Company") (TSX VENTURE:PDP) is pleased to announce today the Canadian commercial launch of Otixal™ (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution for the treatment of acute otitis media with tympanostomy tubes ("AOMT") in pediatric patients (aged 6 months and older). Otixal™ is the first and only antibiotic and steroid combination ear drop available in single, sterile, preservative-free and unit-dose packaging. Otixal™ will be launched in a growing $20 million market1. Pediapharm acquired the exclusive market rights of Otixal™ in Canada from Laboratorios SALVAT S.A. Barcelona, Spain. "Otixal is currently being distributed within the various wholesalers and pharmacy channels. Our Canada-wide sales force has been trained and is eager to present this innovation to healthcare providers" said Richard Labelle vice-president sales and marketing of Pediapharm. He added: "Given its strong medical evidence and its unique single-use, premeasured dosing that helps ensure an accurate dose every time, Otixal has the potential to significantly improve the quality of life of many young patients who have undergone tympanostomy tube insertion and are suffering from acute otitis media". "It is exciting to further expand the international commercial availability of Otixal through the partnership with Pediapharm Inc." said Alberto Bueno, CEO of SALVAT. "This new launch of Otixal is a major milestone for SALVAT as we continue to grow our presence in the North American market". Otixal™ (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa. Two phase 3 multicenter, randomized, double-blind, active-controlled, parallel group trials were conducted to assess the efficacy and safety of Otixal™ compared to ciprofloxacin otic solution and to fluocinolone acetonide otic solution. In total 662 (331 in each study) pediatric patients (aged 6 months to 12 years old) with AOMT were included. In both trials, the Otixal™ treatment arms showed significantly shorter times to cessation of otorrhea in comparison to both the ciprofloxacin and fluocinolone acetonide alone arms. In Study 1 and Study 2 the median time to cessation of otorrhea in the Otixal™ group was 3.75 days and 4.94 days, respectively. Laboratorios SALVAT is a privately owned pharmaceutical group closely identified with technological innovation and strongly committed to R&D. Founded in 1955, Salvat is headquartered in Barcelona (Spain) and is present in over 60 countries and keeps strengthening its international presence through the licensing of its own developments. Salvat launched CETRAXAL® (ciprofloxacin 0.2 %) otic solution in the US in 2009 and received FDA approval for OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution in April 2016. OTOVEL® was commercially launched in the US market by Arbor Pharmaceuticals Ltd. in August 2016. Additional information regarding Laboratorios SALVAT and its products is available at http://www.salvatbiotech.com Pediapharm is the only Canadian specialty pharmaceutical company dedicated to serving the needs of the pediatric community. Its mission is to bring to the Canadian market the latest innovative pediatric products with the objective to improve the health and the well-being of children in Canada. Since its debut in 2008, Pediapharm has entered into numerous commercial agreements with partners from Canada and other countries around the world. The Company's innovative product portfolio includes NYDA®, a breakthrough treatment for head lice; EpiCeram®, a non-steroid emulsion for eczema; naproxen suspension, indicated to treat pain and inflammation due to various conditions, including Juvenile Idiopathic Arthritis; Rupall™, an innovative new allergy medication with a unique mode of action; Otixal™, the first and only antibiotic and steroid combination ear drop available in single, sterile, preservative-free and unit-dose packaging; and Cuvposa™, for severe drooling, which is under review with Health Canada. This news release contains forward-looking statements and other statements that are not historical. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to vary materially from target results and the results or events predicted in these forward-looking statements. As a result, investors are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements contained in this news release are made as of the date of this release. Except as required by applicable law, the Corporation disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Forward-looking information reflects the current expectations or belief of the Corporation based on information currently available and such information is subject to a number of assumptions, risks and uncertainties described in details at pp. 35 to 41 of the Management Information Circular of Chelsea Acquisition Corporation dated November 12, 2013 available on SEDAR at www.sedar.com and other risks associated with being a specialty pharmaceutical company. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


News Article | May 18, 2017
Site: www.marketwired.com

N'EST PAS DESTINÉ À LA DISTRIBUTION AUX AGENCES DE PRESSE AMÉRICAINES NI À LA DIFFUSION AUX ÉTATS-UNIS. Pediapharm inc. (« Pediapharm » ou la « Société ») (TSX CROISSANCE:PDP) est heureuse d'annoncer le lancement commercial au Canada des gouttes auriculaires OtixalMC (ciprofloxacine à 0,3 % et acétonide de fluocinolone à 0,025 %) pour le traitement de l'otite moyenne aiguë (OMA) chez les enfants de six mois et plus ayant un drain transtympanique. Les gouttes auriculaires OtixalMC sont les premières et les seules fabriquées à partir d'une combinaison d'antibiotique et de stéroïde offertes en doses unitaires stériles sans agent de conservation. OtixalMC sera lancé dans un marché en pleine expansion évalué à près de 20 millions de dollars1. Pediapharm a acquis les droits canadiens exclusifs sur OtixalMC de Laboratorios SALVAT S.A., établi à Barcelone, en Espagne. « Otixal est actuellement en distribution chez les grossistes et les pharmacies. Notre équipe de vente à l'échelle du Canada a reçu une formation sur ce médicament novateur et a très hâte de le présenter à la communauté médicale canadienne », s'est réjoui Richard Labelle, vice-président, Ventes et Marketing de Pediapharm. « Comme en témoignent les solides preuves cliniques de son efficacité et grâce à ses doses individuelles prémesurées, uniques en leur genre qui facilitent l'administration de doses exactes à tout coup, Otixal pourrait améliorer considérablement la qualité de vie de nombreux jeunes patients avec un drain transtympanique souffrant d'otite moyenne aiguë ». « Nous sommes heureux de venir accroître la disponibilité commerciale d'Otixal à l'international grâce à ce partenariat avec Pediapharm inc. », a affirmé Alberto Bueno, chef de la direction de SALVAT. « Ce lancement est une étape importante pour SALVAT, qui continue de renforcer sa présence sur le marché nord-américain. » OxitalMC (ciprofloxacine à 0,3 % et acétonide de fluocinolone à 0,025 %) est indiqué pour le traitement, chez les enfants de six mois et plus ayant un drain transtympanique, de l'otite moyenne aiguë due à diverses bactéries : Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis et Pseudomonas aeruginosa. L'efficacité et l'innocuité d'OxitalMC, par rapport à la solution de ciprofloxacine et à la solution d'acétonide de fluocinolone prises seules, ont été évaluées au moyen de deux essais de phase III multicentriques randomisés à double insu avec traitement de référence et groupe parallèle. En tout, 662 patients âgés entre 6 mois et 12 ans souffrant d'OMA et ayant un drain transtympanique ont participé à l'étude. Dans les deux essais, le délai moyen de cessation de l'otorrhée chez les patients ayant pris OxitalMC a été, respectivement, de 3,75 jours et de 4,94 jours. Laboratorios SALVAT est un groupe pharmaceutique privé étroitement associé à l'innovation technologique et fortement axé sur la R et D. Fondée en 1955 et présente aujourd'hui dans plus de 60 pays, cette société établie à Barcelone renforce toujours plus sa présence internationale en octroyant des licences pour ses produits. En 2009, elle a lancé sur le marché américain la solution auriculaire CetraxalMD (ciprofloxacine à 0,2 %), et en avril 2016, la FDA a approuvé OtovelMD (ciprofloxacine à 0,3 % et acétonide de fluocinolone à 0,025 %). Le lancement commercial d'OtovelMD a été effectué par Arbor Pharmaceuticals Ltd. en aout 2016. Pour en savoir plus sur Laboratorios SALVAT et ses produits, consultez le www.salvatbiotech.com. Pediapharm est la seule entreprise pharmaceutique canadienne spécialisée en pédiatrie. Elle a pour mission de commercialiser des produits pédiatriques novateurs visant à améliorer la santé et le bien-être des enfants au Canada. Depuis sa création en 2008, Pediapharm a conclu de nombreux accords commerciaux avec des partenaires du Canada et d'autres pays. Son portfolio de produits innovateurs compte notamment NYDAMD, un traitement révolutionnaire des poux de tête; EpiCeramMD, une crème non stéroïdienne pour le traitement de l'eczéma; la suspension de naproxen, utilisée dans le traitement de la douleur et de l'inflammation causées par diverses affections, dont l'arthrite juvénile; RupallMC, une innovation dans le traitement médical des allergies avec un mode d'action unique; les gouttes auriculaires OtixalMC, qui sont les premières et les seules fabriquées à partir d'une combinaison d'antibiotique et de stéroïde offertes en doses unitaires stériles sans agent de conservation; ainsi que CuvposaMC, pour la sialorrhée grave, qui est présentement sous réserve de l'approbation de Santé Canada. Ce communiqué de presse contient des énoncés prospectifs et d'autres énoncés qui ne sont pas des faits historiques. Ceux-ci sont assujettis à des risques connus ou inconnus, à des incertitudes et à des hypothèses qui pourraient donner lieu à des résultats très différents des résultats visés et des résultats ou événements prévus dans ces énoncés prospectifs. Par conséquent, les investisseurs sont avisés qu'ils ne doivent pas se fier indûment aux énoncés prospectifs. Les énoncés prospectifs figurant dans ce communiqué de presse sont formulés à la date de publication. À moins d'y être tenue selon les lois applicables, la Société nie expressément toute intention ou obligation de mettre à jour ou de réviser tout énoncé prospectif, que ce soit à la lumière de nouveaux renseignements, d'événements futurs ou autrement. L'information prospective reflète les attentes ou croyances actuelles de la Société selon les renseignements qu'elle détient à ce jour, et ces renseignements sont fondés sur différentes hypothèses et assujettis à des risques et incertitudes, décrits en détail aux pages 35 à 41 de la circulaire d'information de la direction de Chelsea Acquisition Corporation, datée du 12 novembre 2013 et disponible sur SEDAR au www.sedar.com, ainsi qu'aux autres risques découlant du fait qu'elle est une entreprise pharmaceutique spécialisée. La Bourse de croissance TSX et son fournisseur de services de réglementation (au sens des politiques de la Bourse de croissance TSX) n'assument aucune responsabilité quant à l'exactitude ou à la précision du présent communiqué.


Millennial moms reported similar experiences, with 71 percent of those surveyed who had experienced head lice in their households reporting they had failed to treat the condition successfully.2 In fact, when asked about their treatment experiences, 46 percent of moms surveyed said they were most fearful of a recurrence while 40 percent expressed doubts that they were thorough enough in removing the lice or nits from their family members.2 "Navigating a head lice diagnosis may feel frustrating and overwhelming for many parents, especially if their child has required multiple rounds of treatment due to a recurring infestation," said Wendy L. Wright, nurse practitioner and owner of Wright & Associates Family Healthcare. "With the new school year approaching, parents should get to know the facts about head lice management so that they feel empowered to partner with their health care provider and have a frank discussion about treatment options." Findings also demonstrated that moms would go to extreme lengths to avoid head lice in their homes. Head lice are considered so bothersome that 71 percent of the 1,000 moms surveyed cleaned everything in the house. Over half of moms say that if given the option, they would rather give up chocolate (53 percent), wine (52 percent) and coffee (50 percent) for a week than experience head lice.2 "The findings from this survey give us insight into the perceptions and concerns of some parents who are battling a head lice infestation in their household," said Ed Schutter, president and CEO, Arbor Pharmaceuticals. "We are committed to serving as a resource for the families who are fighting this widespread, equal opportunity condition and ensuring they are armed with the information they need." While head lice are not dangerous and do not carry any diseases,3 the survey illustrates the social and emotional impact the condition can have. Almost all (97 percent) millennial moms surveyed say they worry about the consequences of head lice on their children and households, including lost time at school (58 percent), inconvenience of an infestation (49 percent), fear of their child being bullied (45 percent), personal anxiety resulting from social stigma associated with the condition (44 percent), criticism from other parents (39 percent), ruined clothing or property (27 percent) and their own lost time at work (24 percent).2 Furthermore, 77 percent of moms surveyed say that their child was negatively affected, either socially, mentally, and/or physically, by having head lice.2 The Facts of Lice survey findings highlight the need for effective conversations between parents and HCPs about head lice management. To address these findings, Arbor Pharmaceuticals has developed educational resources to ensure moms are armed with tools to encourage conversations with their child's doctor and help inform their understanding of how to get a head lice infestation under control. Resources are available at Sklice.com. About Head Lice  Head lice are parasitic insects found on the head, eyebrows and eyelashes of people.3 Head lice have three forms: the egg (also known as a nit), the nymph and the adult.3 Nits are often yellow or white, oval-shaped and the size of a thread knot.3 Nymphs look like smaller adult head lice, which have six legs, are mostly tan to grayish white in color, and are about the size of a sesame seed.3 The most common symptom of head lice is itching, which is caused by an allergic reaction to louse saliva.5 Head lice are spread by direct contact with the hair of an infested person,3 and are most common in children who come into close contact with others who are experiencing a head lice infestation.4 The U.S. Centers for Disease Control (CDC) estimates six to 12 million infestations occur annually in children ages three to 11 years old in the U.S.4 Misdiagnosis of head lice is common.6 Parents should consult a health care provider at the first sign of head lice to confirm a diagnosis and discuss treatment options. About the Survey  The Facts of Lice survey was conducted by ORC International on behalf of Arbor Pharmaceuticals between March 28 – April 10, 2017. Results of the survey were drawn from a representative sample of 1,000 U.S. millennial moms ages 18-35, and 350 U.S. health care providers (HCPs), including pediatricians, pediatric nurse practitioners and pediatric nurses. Respondents were members of an online panel that agreed to participate in online surveys and polls. About Sklice (ivermectin) Lotion, 0.5% Sklice (ivermectin) Lotion, 0.5% is an FDA-approved topical treatment indicated for head lice infestations in patients six months of age and older.7 Sklice Lotion is a one-tube, 10-minute treatment that does not require nit combing.7 The active ingredient in Sklice Lotion is ivermectin, which works by binding to the invertebrate muscle and nerve cells of parasites, causing paralysis and killing the lice and nymphs.7 Sklice Lotion was FDA-approved on February 7, 2012, and is the only FDA-approved head lice treatment with the active ingredient ivermectin. Sklice Lotion is the leading prescription head lice treatment in the U.S., with more than 980,000 prescriptions filled to date.8,9 Sklice Lotion is marketed and distributed by Arbor Pharmaceuticals and is available nationwide. ADJUNCTIVE MEASURES Sklice Lotion should be used in the context of an overall lice management program: A fine-tooth comb or special nit comb may be used to remove dead lice and nits. IMPORTANT SAFETY INFORMATION In order to prevent accidental ingestion, Sklice Lotion should only be administered to pediatric patients under the direct supervision of an adult. The most common adverse reactions (incidence <1%) include conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation. About Arbor Pharmaceuticals LLC Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital and pediatric markets. The company has over 750 employees including 625 sales professionals promoting its products to physicians, hospitals, and pharmacists. Arbor currently markets 22 NDA or ANDA approved products with over 40 more in development. For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to info@arborpharma.com. For any US media inquiries, please contact: PJ Cadman, Brand Manager 404-496-5908, PJ.Cadman@ArborPharma.com


An avermectin-based topical formulation is disclosed which is useful for prevention and treatment of head lice (Pediculus humanus capitis). This topical formulation may be formulated as a shampoo-condition which comprises an effective amount of avermectin, solubilizers, suspending agents, preservatives, nonionic surfactants, humectants, a silicone compound, and water. Also disclosed are methods of using the topical formulations disclosed within this specification to treat either a susceptible or treatment-resistant strain of lice, as well as uses in the manufacture of a medicament for treating or preventing a lice infestation from a susceptible or treatment-resistant strain in a human patient.


News Article | May 9, 2017
Site: marketersmedia.com

— The Psoriasis market report titled “Psoriasis - Pipeline Review, H1 2017" report provides an overview of Psoriasis clinical trials scenario. Browse the 209 Tables and 10 Figures, 150 Company Profiles, Spread across 648 Pages Report Available at http://www.reportsnreports.com/reports/983978-psoriasis-pipeline-review-h1-2017.html Psoriasis market companies are 3SBio Inc,AbbVie Inc,Abeome Corp,AbGenomics International Inc, Addex Therapeutics Ltd, Adello Biologics LLC, Advinus Therapeutics Ltd, Affibody AB, Albireo Pharma Inc, Alfacyte Ltd, Allergan Plc, Almirall SA, Alteogen Inc, Alvotech Iceland, Amgen Inc, Anacor Pharmaceuticals Inc, AnaptysBio Inc, ApoPharma Inc, Arbor Pharmaceuticals LLC, Arena Pharmaceuticals Inc, Argos Therapeutics Inc, Arrien Pharmaceuticals LLC, AstraZeneca Plc, Athenex Inc, Atlantic Bio Sci LLC, Aurigene Discovery Technologies Ltd, Aurinia Pharmaceuticals Inc, Bayer AG, Beta Pharma Inc, BioApex sro, Biocad, Biocon Ltd, BioLingus AG, BioMAS Ltd, Biomics Biotechnologies Co Ltd,Bionomics Ltd, Bionovis SA, BirchBioMed Inc,Boehringer Ingelheim GmbH,Brickell Biotech Inc,Bristol-Myers Squibb Company,C4X Discovery Holdings PLC,CalciMedica Inc,Can-Fite BioPharma Ltd,Celgene Corp,Cell Medica Ltd,Cellceutix Corp,ChemoCentryx Inc,Chipscreen Biosciences Ltd,ChironWells GmbH,Coherus BioSciences Inc,Compugen Ltd,Concenter BioPharma Silkim Ltd,Crescita Therapeutics Inc,CritiTech Inc,Curapel Ltd,Dermala Inc,Dr. August Wolff GmbH & Co KG Arzneimittle,DURECT Corp,EA Pharma Co Ltd,Eli Lilly and Company,ELORAC Inc,Exicure Inc,Foamix Pharmaceuticals Ltd,Forward Pharma A/S,Galapagos NV,Galderma SA many more.. Place Order to This Report at http://www.reportsnreports.com/purchase.aspx?name=983978 . The Psoriasis market pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. The pipeline guide reviews pipeline therapeutics for Psoriasis (Immunology) by companies and universities/research institutes based on information derived from company and industry-specific sources. The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. The pipeline guide encapsulates all the dormant and discontinued pipeline projects. The pipeline guide reviews latest news related to pipeline therapeutics for Psoriasis (Immunology). The Psoriasis (Immunology) pipeline guide also reviews of key players involved in therapeutic development for Psoriasis and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Filing rejected/Withdrawn, Phase III, Phase II, Phase I, IND/CTA Filed, Preclinical, Discovery and Unknown stages are 14, 1, 21, 44, 42, 1, 103, 32 and 9 respectively. Similarly, the Universities portfolio in Preclinical and Discovery stages comprises 8 and 6 molecules, respectively. Psoriasis (Immunology) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Reasons to buy • Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies. • Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage. • Find and recognize significant and varied types of therapeutics under development for Psoriasis (Immunology). • Classify potential new clients or partners in the target demographic. • Develop tactical initiatives by understanding the focus areas of leading companies. • Plan mergers and acquisitions meritoriously by identifying key players and it's most promising pipeline therapeutics. • Formulate corrective measures for pipeline projects by understanding Psoriasis (Immunology) pipeline depth and focus of Indication therapeutics. • Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope. • Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline. About Us: ReportsnReports.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 95 leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports. For more information, please visit http://www.reportsnreports.com/reports/983978-psoriasis-pipeline-review-h1-2017.html


News Article | December 22, 2016
Site: www.eurekalert.org

In experiments on mice with a form of aggressive brain cancer, Johns Hopkins researchers have shown that localized chemotherapy delivered directly to the brain rather than given systemically may be the best way to keep the immune system intact and strong when immunotherapy is also part of the treatment. The researchers say their study results, reported Dec. 21 in Science Translational Medicine, could directly affect the design of immunotherapy clinical trials and treatment strategies for people with a deadly form of brain cancer called glioblastoma. "We understand that our research was done in a mouse model and not in humans, but our evidence is strong that systemic chemotherapy alters the immune system in a way that it never fully recovers," says Michael Lim, M.D., associate professor of neurosurgery and director of brain tumor immunotherapy at the Johns Hopkins University School of Medicine, and member of the Johns Hopkins Kimmel Cancer Center. "With aggressive cancers like glioblastoma, it is important that we don't handicap the defenses we may need to add alternative treatments, such as immunotherapy, to chemotherapy," he adds. Lim's laboratory in neurosurgery and a team from the Bloomberg~Kimmel Institute for Cancer Immunotherapy led by Drew Pardoll, M.D., Ph.D., performed their studies in a mouse with glioblastoma. In people, glioblastoma is a particularly aggressive form of cancer, with a typical survival time of just over a year after diagnosis. Current treatments include surgical removal of the visible tumor, radiation and chemotherapy. Because the disease is so lethal, even after aggressive standard treatment, neurosurgeons like Lim are looking to add newer immunotherapies that use the body's own immune system cells to fight the tumor. However, one challenge to immunotherapy, Lim says, has been the potential toxic effects of systemic therapies that could damage or interfere with the immune system and weaken the chances for success of immunotherapy approaches. With clinical trials being designed to integrate standard of care with immunotherapy, Lim and his team sought to create a way to accurately assess the impact of localized versus systemic chemotherapy on the immune system's ability to stay healthy, and to see which kind of chemotherapy would actually improve survival time in the test mice. To determine if one method of chemotherapy delivery was better over another when combined with immunotherapy, the researchers first gave a group of mice with glioblastoma clinically relevant doses the immunotherapy drug anti-PD-1 (200 milligrams per kilogram) and then treated the mice with chemotherapy either throughout the whole body or directly to the brain over two weeks. For the whole-body, or systemic, chemotherapy, the mice were injected in their bellies with 30 milligrams per kilogram of the chemotherapy drug carmustine -- the same drug used against glioblastoma in people -- three times a week. Each treatment group contained 15 mice. For the local chemotherapy, the researchers directly implanted a wafer covered in molecules that bound carmustine, allowing sustained release of the drug over a week, into mice with established brain tumors. The researchers first took blood samples from the rodents' lymph nodes, brain, bone marrow and blood a couple of days after the end of the chemotherapy treatments, almost two weeks later and at the four-month mark. They focused on counting the number of white blood cells called lymphocytes (T cells) as a way to measure immune system integrity. The mice given systemic chemotherapy had much lower levels of lymphocytes than the mice given the local, long-lasting chemotherapy. For example, two weeks after treatment, mice with systemic chemotherapy had only about a third of the lymphocytes in their circulating blood as mice given the local chemotherapy. The researchers say their findings align with what is observed clinically in patients who received systemic chemotherapy. Lim says the suppression is suggested that the lymphocyte depletion caused by systemic chemotherapy is likely counterproductive to producing an effective antitumor immune response. Next, the team wanted to see if local versus systemic chemotherapy in conjunction with immunotherapy affected survival in the mice with glioblastoma. The scientists found that when they gave the mice chemotherapy locally, it acted together with the immunotherapy drug to improve survival to about 80 percent after 100 days when compared to mice receiving immunotherapy alone, local chemotherapy alone, or combined systemic chemotherapy and immunotherapy, with a survival rate of about 50 percent after 100 days. Then, they followed up these experiments by assessing the immune system's memory. They gave mice local chemotherapy or systemic chemotherapy in conjunction with immunotherapy, and then implanted them with more tumors. The mice with the systemic chemotherapy and immunotherapy all died when injected with extra tumors. But the mice with local chemotherapy and immunotherapy survived, essentially immunized against their glioblastoma. The researchers say this suggests that the systemic chemotherapy profoundly weakens the immune system. The researchers showed that the immune system weakening phenomenon isn't specific to carmustine and happens in multiple types of systemic chemotherapy, such as temozolomide. The researchers also reversed the treatment protocols, giving the chemotherapy before the immunotherapy to see if that worked better and improved survival. They didn't notice a difference in survival time whether the immunotherapy was given before or after the brain-specific chemotherapy. Only 10 percent of people diagnosed with glioblastoma live more than five years, according to the American Brain Tumor Association. Glioblastoma mostly occurs in people over 45 and in men somewhat more often than in woman. An estimated 15 percent of the 78,000 people diagnosed with brain tumors in the U.S. each year will be diagnosed with glioblastoma. Currently, a large number of immunotherapy trials are underway for patients with glioblastoma. There are only three immunotherapy drugs that are FDA-approved for treating other types of cancer, and they cost over $100,000 annually. The study was funded by Arbor Pharmaceuticals and other philanthropy, including funds from Agenus, Altor, BMS, Immunocellular, Celldex and Accuray. Lim is a consultant for Agenus, BMS, Merck, Oncorus, Accuray and Stryker. The study authors hold a patent and have applied for a second one for the concept of combining local chemotherapy and immunotherapy.

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