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TORONTO--(BUSINESS WIRE)--Bio Pharma Services, Inc. (Bio Pharma) vient de célébrer son 10ème anniversaire en annonçant l'inspection réussie par l'AEM de son site clinique et bio-analytique basé à Toronto. L'inspection de cinq jours, qui comprenait un audit complet des unités cliniques, bio-analytiques et pharmacocinétiques, a été la première inspection réalisée par l'Agence nationale de sécurité du médicament et des produits de santé (ANSM, France) et l'Agence danoise des médicaments (DKMA) chez Bio Pharma. Avec les résultats très positifs de cette dernière inspection, Bio Pharma continue de renforcer ses accomplissements en matière de réglementation et vient de finaliser ses inspections pour toutes les grandes juridictions, au niveau mondial. Le respect exemplaire de Bio Pharma en matière de réglementation s'appuie notamment sur des inspections réalisées par la FDA américaine, la MHRA britannique, Santé Canada, le Conseil canadien des normes et ANVISA. Andjica Tasic, vice-présidente, en charge de la garantie qualité et des affaires réglementaires chez Bio Pharma, déclare: "Le résultat positif de cette inspection de l'AEM représente des années de travail. Chez Bio Pharma, nous sommes tous fermement engagés en faveur de l'amélioration continue, de la recherche de l'excellence et de l'exécution de l'activité R&D en appliquant les normes les plus strictes." Bio Pharma Services Inc. est un organisme de recherche sous contrat (ORC) spécialisé dans la réalisation d'essais cliniques de Phase I/IIa ainsi que d'essais de bio-équivalence pour les compagnies pharmaceutiques internationales. Avec des centres cliniques à Columbia (Missouri) et Toronto (Canada), la capacité totale en lits de Bio Pharma s'élève 250 unités, avec une solide base de données de volontaires en bonne santé, de populations spécifiques (notamment des femmes post-ménopausées, des hommes atteints d'hypogonadisme, et des consommateurs de drogues douces) et de patients. Avec son siège à Toronto (Canada), les services exhaustifs de Bio Pharma incluent la bio-analyse dans son laboratoire certifié GLP, les affaires PK/scientifiques et réglementaires, les analyses de données biostatistiques et d'innocuité, la rédaction médicale et la gestion des données.


TORONTO--(BUSINESS WIRE)--Bio Pharma Services, Inc. (Bio Pharma) ended their 10th year anniversary celebrations by announcing the successful EMA inspection of their Toronto based clinical and bioanalytical site. The 5-day inspection which included a complete audit of their clinical, bioanalytical and pharmacokinetic units, was the first inspection conducted by the French National Agency for Medicines and Health Products Safety (ANSM) and the Danish Medicines Agency (DKMA) at Bio Pharma. With the strong and positive outcome of this last inspection, Bio Pharma continues to build on its impressive regulatory achievements, having now completed inspections for all major jurisdictions in the global marketplace. Bio Pharma's outstanding regulatory history includes successful inspections by the US FDA, UK MHRA, Health Canada, Standards Council of Canada and ANVISA. “This EU GCP audit comes on the heels of Bio Pharma successfully renewing its GLP certification with the Standards Council of Canada (SCC) just last week. Our attention to detail and high quality is what sets us apart in the marketplace. I am very proud of our contributions to safe and effective medicines,” stated Bio Pharma’s CEO, Renzo DiCarlo. Andjica Tasic, Vice-President, Quality Assurance and Regulatory Affairs at Bio Pharma added: "The successful outcome of this EMA inspection was years in the making. All of us here at Bio Pharma are committed to continuous improvement in our pursuit of excellence and executing R&D to the highest of standards.” Bio Pharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide. With clinical facilities in Columbia, Missouri and Toronto, Canada, Bio Pharma’s total bed capacity sits at 250 with an impressive subject database of healthy volunteers, special populations (which includes post-menopausal females, hypogonadal males, and recreational drug users) and patients. Headquartered in Toronto, Canada, Bio Pharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.


PubMed | CNAMTS, HAS, University of Lyon, Assistance publique Hopitaux de Paris and 15 more.
Type: Journal Article | Journal: Therapie | Year: 2015

Personalized medicine is based on: 1) improved clinical or non-clinical methods (including biomarkers) for a more discriminating and precise diagnosis of diseases; 2) targeted therapies of the choice or the best drug for each patient among those available; 3) dose adjustment methods to optimize the benefit-risk ratio of the drugs chosen; 4) biomarkers of efficacy, toxicity, treatment discontinuation, relapse, etc. Unfortunately, it is still too often a theoretical concept because of the lack of convenient diagnostic methods or treatments, particularly of drugs corresponding to each subtype of pathology, hence to each patient. Stratified medicine is a component of personalized medicine employing biomarkers and companion diagnostics to target the patients likely to present the best benefit-risk balance for a given active compound. The concept of targeted therapy, mostly used in cancer treatment, relies on the existence of a defined molecular target, involved or not in the pathological process, and/or on the existence of a biomarker able to identify the target population, which should logically be small as compared to the population presenting the disease considered. Targeted therapies and biomarkers represent important stakes for the pharmaceutical industry, in terms of market access, of return on investment and of image among the prescribers. At the same time, they probably represent only the first generation of products resulting from the combination of clinical, pathophysiological and molecular research, i.e. of translational research.


PubMed | CNAMTS, Laboratoire MSD, Marta Gersberg Conseil, Hopital Saint Louis and 13 more.
Type: Guideline | Journal: Therapie | Year: 2015

A biosimilar is a biological medicinal product claimed to be similar to a reference biological medicinal product. Its development plan includes studies comparing it with the reference product in order to confirm its similarity in terms of quality, preclinical safety, clinical efficacy, and clinical safety, including immunogenicity. Biosimilars differ from generics both in their molecular complexity and in the specific requirements that apply to them. Since patents on many biological medicinal products will expire within the next 5 years in major therapeutic areas such as oncology, rheumatology and gastroenterology and as those products are so costly to the French national health insurance system, the availability of biosimilars would have a considerable economic impact. The round table has issued a number of recommendations intended to ensure that the upcoming arrival of biosimilars on the market is a success, in which prescribing physicians would have a central role in informing and reassuring patients, an efficient monitoring of the patients treated with biologicals would be set up and time to market for biosimilars would be speeded up.


News Article | February 17, 2017
Site: globenewswire.com

GOTHENBURG, Sweden, February 17, 2017 - Immunicum AB (publ; First North Premier: IMMU.ST) a biopharmaceutical company advancing a novel immuno-oncology treatment against a range of solid tumors, today announced financial results for the year ended December 31, 2016 and provided a corporate update and overview of the Company's activities. Carlos de Sousa, MD, CEO of Immunicum, will conduct a webcast and conference call to present the update today at 10:00 am CET. Information for joining the webcast and call are listed at the end of this press release. Significant events during the second quarter year On October 26, 2016, the Annual General Meeting ("AGM") of Immunicum AB elected Steven Glazer, Charlotte Edenius and Kerstin Valinder Strinnholm as new Board members. Agneta Edberg, Martin Lindström, Magnus Nilsson and Magnus Persson were all re-elected as Board members. Bengt Furberg declined re-election. Agneta Edberg was re-elected as Chairman of the Board. The AGM also resolved to authorize the Board of Directors to, on one or several occasions during the period until the next Annual General Meeting, with or without deviation from the shareholder's preferential rights, resolve on new share issues of a maximum of 5,040,000 shares. AGM also resolved to change the fiscal year of the Company to calendar year as well as to shorten the current fiscal year to cover the period July 1, 2016 - December 31, 2016. On November 14, 2016, at the Society for Immunotherapy of Cancer (SITC) 31st Annual Meeting, Immunicum presented updated immunological and survival phase I/II data on hepatocellular carcinoma (HCC) patients treated with INTUVAX®. Data showed that 67% of fully treated patients with advanced HCC experienced increases in circulating tumor-specific CD8+ T cells and that these increases appear to correlate with prolonged survival rates seen in the study as compared to historical median overall survival rates. It was furthermore announced that all six additional patients in an extension of the study had been included. These patients received INTUVAX® as first line systemic treatment in combination with standard treatments. On December 13, 2016, Immunicum announced that the United States Food and Drug Administration (FDA) had cleared the Company's Investigational New Drug application (IND) for INTUVAX®. The IND clearance enables Immunicum to expand its ongoing phase II study - MERECA (MEtastatic REnal Cell CArcinoma) - for the treatment of metastatic renal cell cancer patients, into the United States. Significant events after the financial year In February 2017, the Company announced the appointment of Karin Hoogendoorn as Head of Chemistry Manufacturing and Controls (CMC). Dr. Hoogendoorn is a seasoned expert in the development of biotechnological products and has lead successful CMC efforts for a variety of products within positions at Novartis AG, Janssen Biologics BV and Crucell Holland and will be critical for the high quality production of Immunicum's products. In February 2017, the Company announced that the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France has approved the Company's Clinical Trial Application (CTA) for INTUVAX®. The CTA approval enables Immunicum to include patients in France in its ongoing phase II study - MERECA (MEtastatic REnal Cell CArcinoma) - for the treatment of metastatic renal cell cancer. Second quarter (October-December) 2016 compared with the same period in 2015 Financial year (July-December) 2016 compared with the same period in 2015 It is an exciting moment for Immunicum as we prepare for a transformative year in 2017. In addition to advancing our ongoing clinical trials for INTUVAX® and strengthening our leadership team at Immunicum, we continue to refine our near-term objectives for the overall development of our programs and to review all the Company's activities to ensure that we have the right team, right resources and right focus in place to build the most value for our investors. Since the Company's inception, Immunicum has achieved the clinical stage development of a promising immuno-oncology therapeutic approach for treating a range of solid tumors. It is a major achievement for a small organization like Immunicum to bring a discovery into multiple clinical trials. It goes without saying that immuno-oncology is one of the most exciting areas of pharmaceutical discovery and development, with the first approved drugs proving the value of the concept that a key way to fight cancer is to re-activate the patient's own immune system to destroy cancerous cells. Immunicum has a unique approach to immune-oncology and we believe that it has the potential to become an important part of treating solid tumors in the future. Our strategy remains to advance our programs successfully into the clinic and ensure the success of these trials. The following is an overview of the most up-to-date information from the INTUVAX® trials in kidney and liver cancer as well as GIST (gastrointestinal stromal tumor). Renal Cell Carcinoma (RCC): The enrollment process for the ongoing MERECA phase II study, where patients with newly diagnosed metastatic renal cell carcinoma are treated with INTUVAX® in combination with sunitinib, has been implemented across Europe. To date, a total of 43 patients have been enrolled at 18 centers in seven European countries. The primary purpose of the MERECA trial is to examine safety as well as clinical benefit in terms of survival rate at 18 months and median overall survival for all patients. The Company will also study the objective tumor response after initiating treatment with sunitinib, as well as study intratumoral infiltration of CD8+ T cells. In the context of this open-label trial, we can report that safety remains positive and that levels of infiltration are in line with what we have seen previously, however, it is still too early to make any further interpretation of data. We will present all these data as well as those from the continued follow-up of the patients from the phase I/II trial in RCC in due course at scientific conferences and in peer-reviewed scientific journals. We announced in December that our Investigational New Drug (IND) application to the Food and Drug Administration (FDA) has been cleared to start enrolling kidney cancer patients in the U.S. as part of the MERECA trial. We anticipate to start this process in the second quarter of 2017. To support this goal, we have optimized the production of the product at a large manufacturing facility in Germany. This has been a positive development for the ongoing trial in EU as well as our preparation for the start of the enrollment in the US. Hepatocellular Carcinoma (HCC): In November 2016 we provided updated immunological and survival data from our clinical phase I/II study in patients with advanced hepatocellular carcinoma which were presented at the Society for Immunotherapy of Cancer's (SITC) annual meeting. The data showed that 67% of fully treated patients with advanced HCC experienced increases in circulating tumor-specific CD8+ T cells. These increases appear to correlate with the prolonged survival rates seen in the study as compared to historical median overall survival rates. In the extension of the study we have now enrolled the last of the six additional liver cancer patients that received INTUVAX® concomitantly with first line standard of care medication. Gastrointestinal Stromal Tumors (GIST): As previously reported, the first patient has been included in our clinical phase I/II study with INTUVAX® in patients with GIST. Because the disease is both rare and complex, we have revised the study protocol in collaboration with the investigators at the Karolinska Institute, and this protocol has been reviewed and approved by the National Authorities and Ethical committee. Clinical Development Plan Analysis: The important information that we will gain from these ongoing trials will complement our ongoing analysis of the cancer treatment landscape to determine the most successful path for INTUVAX®. The most critical decisions here involve considering which indications we should select for the later stage clinical development of the program. There are several aspects to consider: patient need, clinical endpoints for the trial and overall success potential for regulatory approval. Over the last several months, we have considered the possibility of expanding the development plan with additional phase I/ II studies in different indications, such as melanoma, and in different combinations, e.g. with immune checkpoint inhibitors. These considerations are still underway and we look forward to providing an update on them in the near future. Development Programs and Academic Collaborations: Immunicum's major focus is to advance the ongoing clinical studies with INTUVAX®, however, we will continue to invest into deeper investigation of two of our earlier stage applications: CD70 and the adenovirus vector program, where the development is conducted in collaboration with professor Magnus Essand at Uppsala University. For CD70, we are currently evaluating the possibilities for clinical production and for the vector, we are currently conducting preclinical studies within the concept of SUBCUVAX. These efforts will allow us to build additional value from the research conducted to date. Corporate and Organizational Updates: We had the pleasure of announcing the addition of Karin Hoogendoorn as Head of CMC. We will continue to strengthen our leadership team with expertise in product development and production, regulatory strategy and business development to reinforce the strength of the current leadership and build a company well-positioned to succeed. Ongoing Communications Activities: We will continue to place a focus on providing regular updates to our shareholders as well as raising the profile of the Company both through industry and financial events as well as scientific and medical conferences. We will be announcing our participation in conferences in Sweden, Europe and in the US on a more frequent basis. Our vision for the Company is to increase our interaction within the larger biopharmaceutical industry while maintaining our operational focus on the further development of our programs. About Immunicum AB (publ) Immunicum AB (First North Premier: IMMU.ST) is a clinical stage company developing novel immuno-oncology therapies against a range of solid tumors. The Company's lead compound, INTUVAX® is currently being evaluated in clinical trials for the treatment of kidney cancer, liver cancer and gastrointestinal stromal tumors. INTUVAX® was designed to combine the best of two worlds: a cost-effective cell-based (allogeneic) and off-the-shelf therapy that is capable of triggering a highly personalized and potentially long-lasting immune response against tumor cells throughout the body. www.immunicum.com For more information, please contact Carlos de Sousa, CEO, Immunicum Ph: +46 (0) 31 41 50 52 E-mail: info@immunicum.com The information in this press release is disclosed pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the company's contact person on February 17, 2017 at 7:30 CET


PubMed | CNCPP, Voluntis, Assistance Publique Hopitaux de Paris, Eval Sante and 13 more.
Type: Journal Article | Journal: Therapie | Year: 2015

In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jard Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Scurit du Mdicament et des Produits de Sant, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency.


News Article | January 20, 2016
Site: www.nature.com

One person died, and five others were hospitalized, after a clinical trial of an experimental drug in France went tragically wrong. But days after the first public acknowledgement of the incidents on 15 January, a lack of official information has left outside experts and the public largely in the dark as to what happened. “The French authorities have not been very rapid nor transparent in their response,” says Catherine Hill, a specialist in clinical-trial design and a former member of the scientific advisory board of France’s National Agency for Medicines and Health Products Safety (ANSM). She adds that French investigations into other medical accidents have often been opaque. The trial was a ‘first-in-human’ phase I trial to test the drug’s safety in healthy people (see ‘Basic facts about the trial’). The Portuguese company Bial produced the drug, which was aimed at treating anxiety and motor disorders associated with Parkinson’s disease, and chronic pain in people with cancer and other conditions. Biotrial, a French contract-research organization, conducted the trial at its facilities in Rennes. But many key questions remain unanswered, says Marc Rodwin, a biomedical-law specialist at Suffolk University Law School in Boston, Massachusetts. This includes how the participants’ injuries came about — magnetic-resonance-imaging scans showed dying and bleeding tissue deep in the brain — and whether the trials were conducted properly. In particular, neither the French authorities nor Biotrial has disclosed the identity of the molecule administered in the trials. Bial did say that the drug was an FAAH (fatty acid amide hydrolase) inhibitor; FAAH is an enzyme produced in the brain and elsewhere in the body that breaks down neurotransmitters known as endocannabinoids. By blocking these enzymes, FAAH inhibitors cause endocannabinoids — which activate the same neural receptors as the active chemical in cannabis, and might have painkilling properties — to accumulate in the body. Some scientists scrambled over the weekend to try to establish the identity of the drug. Among them were Steve Alexander, a molecular pharmacologist at the University of Nottingham Medical School, UK, who has worked on FAAH for 15 years, and his colleague Christopher Southan, a curator for the Guide to Pharmacology database at the University of Edinburgh, UK. Together, the pair examined an online list of drugs in Bial’s research pipeline. The search revealed just two molecules in phase I trials, one of which fitted the therapeutic profile mentioned by Bial, although it was referred to only by a codename, BIA 10-2474. A French newspaper also published a recruitment form given to a volunteer in the trial that mentioned a drug with the same codename. “As best as we can make out, this compound has not been described in the [scientific] literature,” says Alexander. “So we’re working in the dark.” It is common in the pharmaceutical industry not to reveal the structure of a molecule this early in development — although the practice has been criticized by researchers. “They declare codenames of candidates in development and hide the structure,” says Southan. “I think it’s time they stopped.” That lack of information left researchers trying to guess the structure from published Bial patents over the weekend, Southan adds. He also says that there seems to be no entry for the trial in clinical-trial registries. Numerous companies have developed FAAH inhibitors. There is none on the market, because most clinical trials have shown them to be ineffective — but the ones that were previously tested in people proved safe. Many researchers believe that BIA 10-2474 is acting ‘off target’ — in other words, inhibiting a protein other than an FAAH. To investigate, researchers could radioactively label the compound and test it on brain tissue from cadavers to ‘fish out’ the proteins it binds to. Knowing the drug’s molecular structure would also enable scientists to run computer predictions of this and other mechanisms that might result in toxicity. “There’s a whole gamut of sophisticated computation analysis to predict anything you like,” says Southan. Other researchers studying the FAAH pathway will probably look more closely at the potential for inhibitors to strike other proteins, Alexander says. “I think it’s very likely that both private industry and academic institutions will be looking very hard as to what this off-target affect might be.” The lack of transparency is typical of French investigations, which tend to favour secrecy until firm conclusions are established, says a French health-law specialist who requested anonymity. He notes that the country’s rules governing research on human subjects are strong and guarantee substantial protection of trial participants. He adds that safety incidents in clinical trials are almost unheard of in the country, with the price often being delays in the approval of trial applications. In recent years, there have been two major changes to French laws affecting the approval of drugs in clinical trials. France strengthened its medical-safety laws following the 2009 withdrawal of a diabetes drug that was suspected of causing hundreds of deaths: a 2011 law, in particular, tightened rules on conflicts of interest for people involved in the country’s drug-approval process, as well as giving authorities more power to demand safety tests of medications after they are approved. Then, in 2012, the government passed a separate law intended to streamline the rules for research involving humans, to speed up therapeutic progress and to make France a more attractive place for companies to carry out clinical trials. One possible safety issue in the trial of BIA 10-2474, notes trial-design specialist Hill, is that all six participants seem to have been administered the doses simultaneously, rather than one receiving a test dose and being checked for adverse effects before others were given it. Simultaneous rather than sequential administration was identified as problematic in a disastrous UK clinical trial in 2006 that caused multiple organ failure in six participants. “From the 2006 catastrophe in London, I had concluded that treating several individuals with the same dose on the same day in a phase I trial was a big mistake,” says Hill. Jean-Marc Gandon, the president and chief executive of Biotrial, says that he cannot immediately respond to queries from Nature, that he is focused on trying to save the patients and that the company will respond later. Bial spokeswoman Susana Vasconcelos says that the trial had been conducted “in accordance with all the good international practices guidelines, with the completion of tests and preclinical trials” and that the company “is committed to determine thoroughly and exhaustively the causes which are at the origin of this situation”.


Relano-Gines A.,French National Center for Scientific Research | Gabelle A.,French National Center for Scientific Research | Gabelle A.,Montpellier University Hospital Center | Hamela C.,French National Center for Scientific Research | And 7 more authors.
PLoS Pathogens | Year: 2013

Prion diseases are irreversible progressive neurodegenerative diseases, leading to severe incapacity and death. They are characterized in the brain by prion amyloid deposits, vacuolisation, astrocytosis, neuronal degeneration, and by cognitive, behavioural and physical impairments. There is no treatment for these disorders and stem cell therapy therefore represents an interesting new approach. Gains could not only result from the cell transplantation, but also from the stimulation of endogenous neural stem cells (NSC) or by the combination of both approaches. However, the development of such strategies requires a detailed knowledge of the pathology, particularly concerning the status of the adult neurogenesis and endogenous NSC during the development of the disease. During the past decade, several studies have consistently shown that NSC reside in the adult mammalian central nervous system (CNS) and that adult neurogenesis occurs throughout the adulthood in the subventricular zone of the lateral ventricle or the Dentate Gyrus of the hippocampus. Adult NSC are believed to constitute a reservoir for neuronal replacement during normal cell turnover or after brain injury. However, the activation of this system does not fully compensate the neuronal loss that occurs during neurodegenerative diseases and could even contribute to the disease progression. We investigated here the status of these cells during the development of prion disorders. We were able to show that NSC accumulate and replicate prions. Importantly, this resulted in the alteration of their neuronal fate which then represents a new pathologic event that might underlie the rapid progression of the disease. © 2013 Relaño-Ginès et al.


WEST DES MOINES, Iowa, Nov. 10, 2016 /PRNewswire/ -- Spotlight Innovation Inc. (OTCQB: STLT) announced today that its subsidiary Celtic Biotech Iowa has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to commence Part 2 of its Phase...

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