Medical and Scientific Affairs
Medical and Scientific Affairs
News Article | April 12, 2017
MADISON, Wis., April 12, 2017 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused clinical stage biotechnology company, today announces it has appointed John Friend, II, M.D. as vice president and chief medical officer effective April 17, 2017. “Cellectar has accelerated and expanded its research and development program to include multiple clinical trials for our lead product candidate CLR 131, as well as the active preclinical development of additional compounds utilizing our PDC platform,” said Jim Caruso, president and CEO of Cellectar Biosciences. “John’s depth of drug development experience in the biopharmaceutical industry, specifically, advancing drugs from preclinical stage through clinical studies, as well as successful oversight of the regulatory process, precisely meets our current need in helming our PDC programs and we look forward to benefitting from his leadership.” Dr. Friend, age 47, brings 15 years of global drug development expertise and general management experience in oncology, inflammation, endocrine/metabolism, and pain management to Cellectar. Prior to joining the company, John spent more than seven years at Helsinn Therapeutics leading its research and development division. Most recently he served as senior vice president of Medical and Scientific Affairs at Helsinn, building the non-clinical, clinical, medical and regulatory affairs teams to lead multiple global franchises from early product development to market commercialization. Prior to his time at Helsinn, Dr. Friend held executive responsibility for clinical research, medical affairs, pharmacovigilance and risk management at various pharmaceutical companies including Akros Pharma, Actavis, Alpharma, Hospira and Abbott. After obtaining an undergraduate degree in Chemistry from Southern Methodist University, John earned his medical degree from UMDNJ-Robert Wood Johnson Medical School (now Rutgers, RWJMS). He completed post-graduate residency program in family medicine and subsequently served as clinical director and faculty attending physician at Cabarrus Family Medicine Residency Program in North Carolina. About Cellectar Biosciences, Inc. Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer-targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar's PDC platform is based on the company's proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma, as well as a Phase II clinical study to assess efficacy in a range of B-cell malignancies. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical-stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For more information please visit www.cellectar.com. This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2016. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
News Article | May 18, 2017
The study, by Shusuke Toden, Ph.D., et alia, of Baylor University, Dallas, Texas, published April, 2017, in the journal Scientific Reports, compared the bioactivity of two curcumin products, standardized 95% curcumin and BCM-95, in an imposed animal model of colitis. BCM-95 combines at least 86% pure curcuminoids with essential oils from turmeric, and is patented for a specific 45% content of ar-turmerones within the essential oil blend. In the study, groups were pretreated with standard curcumin or BCM-95 at 5 mg, 25 mg or 50 mg/kg over one week. The standard curcumin/BCM-95 groups were continued in tandem with the 1-week 3% dextran sulfate sodium (DSS) regimen to induce colitis, then compared to the untreated group. From the induction of colitis, disease severity was evaluated daily using the disease activity index (DAI). Changes in colon length, body weight, stool consistency and visible blood in the feces were assessed. Gene expression panels for inflammatory markers were also evaluated. BCM-95-but not standard curcumin-attenuated disease changes more significantly per the DAI (p < 0.001), with the progression of the disease (i.e. day 5 vs. day 7), and with increasing dose (25 mg vs. 50 mg/kg). Moreover, colon-shortening was lessened by the BCM-95 group, whereas no change was observed in the standard curcumin group. The BCM-95 group also modulated significantly more inflammatory genes than did the curcumin group. The most significant changes for the BCM-95 group, as associated with colon inflammation and disease progression, were the up-regulation of anti-inflammatory markers IL-10 and IL-11. These markers were not significantly affected in the standard curcumin group. In another experiment, a stand-alone ar-turmerone-enriched essential oil (ETO) group was compared to the untreated DSS control group, the standard curcumin group, and the BCM-95 group to evaluate ETO's impact on disease activity scores. The BCM-95 group proved ETO to be more beneficial than for all other groups, strongly suggesting that synergism is at play in the enhanced bioactivity results. The specific content of essential oil-derived sesquiterpenes, known as ar-turmerones, at a 45% ratio of the oils, complements the 86% content of curcumin in making BCM-95 novel. "Of all the non-curcumin constituents evaluated thus far, such aromatic turmerones have been regarded as the most favorable in complementing the anti-inflammatory and antioxidant action of curcumin," says Shavon Jackson-Michel, ND, Medical and Scientific Affairs Advisor for DolCas Biotech. "The enhanced benefit realized by the combination of ar-turmerone enhanced essential oils with curcumin, as uniquely found in BCM-95, suggests that, while ETO does not offer significant benefit on its own, it adds to the anti-inflammatory profile of curcumin." DolCas Biotech, LLC, owns the worldwide brand rights of BCM-95 in a joint venture with India-based manufacturer, Arjuna Naturals Extracts, Ltd. With full oversight of BCM-95's entire supply chain, a 14-year history of safe use, and GRAS status (as affirmed by a panel of experts), DolCas and Arjuna offer the industry a pure, clean, and safe raw material. The two companies have diligently collaborated with renowned researchers, domestically and internationally, to additionally establish BCM-95 as a clinically studied, science-backed ingredient. BCM-95 has been awarded 12 patents and consistently makes headlines with cutting-edge research, such as this colitis study. "The confirmation of synergism provides partners-for example Europharma and Life Extension-a significant advantage in marketing their BCM-95 based formulas as verified for bioavailability and enhanced bioactivity," adds Jackson-Michel. For more information, contact: Company contact DolCas Biotech, LLC Mr. Nipen Lavingia VP of Business Development Tell: 973-347-1958 ext. 213 Email: email@example.com Web: http://www.dolcas-biotech.com
News Article | December 19, 2016
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today the European Commission (EC) has approved an expanded indication for Nimenrix™ (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. Nimenrix is now the first and only MenACWY conjugate vaccine in the European Union (EU) that can be administered from six weeks of age with no upper age limit. “With this approval, Nimenrix now has the broadest age indication of any conjugate vaccine in Europe against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y, to help protect people as young as six weeks of age,” said Luis Jodar, Chief Medical and Scientific Affairs Officer for Pfizer Inc. “At Pfizer, our expertise in bringing new indications and therapies to people in need helps enable us to continually improve and expand our portfolio of potentially life-saving vaccines.” The EU approval is based upon results from a Phase 3, open-label, randomized, controlled study (study MenACWY-TT-083) in which the immunogenicity and safety of Nimenrix was evaluated in over 1,000 healthy infants from six weeks of age. Based on clinical evidence, Nimenrix was approved for administration in infants as a two dose primary series, with the first dose given from six weeks of age and with an interval of two months between doses, followed by a booster dose at 12 months. The six confirmatory co-primary objectives of the study were met. Pfizer’s Meningococcal Vaccines portfolio includes vaccines that help protect against the five most common disease-causing serogroups – A, C, W-135, Y, and B (approvals varying by country) – which can threaten the health of people at various points in their lives. The risk of contracting meningococcal disease varies year to year, by age group and by the country one travels to or lives in. Indication for Nimenrix in the EU Nimenrix is indicated for active immunization of individuals from the age of six weeks and above against invasive meningococcal disease caused by Neisseria meningitidis group A, C, W-135, and Y. Nimenrix™ (meningococcal group A, C, W-135, and Y conjugate vaccine) should not be given to anyone with a history of a severe allergic reaction after a previous dose of Nimenrix. Individuals with weakened immune systems may have a reduced immune response. The most common adverse reactions were loss of appetite, irritability, drowsiness, pain at the injection site, fatigue, redness at the injection site, and swelling at injection site. Tell your healthcare provider if you are pregnant, or plan to become pregnant. Ask your healthcare provider about the risks and benefits of Nimenrix. Only a healthcare provider can decide if Nimenrix is right for you or your child. You are encouraged to report negative side effects of vaccines to Pfizer. In the United States, to report suspected adverse reactions, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. About Nimenrix (Meningococcal Group A, C, W-135, and Y Conjugate Vaccine) Nimenrix is a meningococcal ACWY (MenACWY) conjugate vaccine that uses tetanus toxoid (TT) as a carrier protein to help protect individuals against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y, which can threaten the health of people at various points in their life. Nimenrix was the first and only MenACWY conjugate vaccine that could be administered from 12 months of age in a single dose with no upper age limit (depending on country)1 and now the vaccine can be administered from six weeks of age and older. Nimenrix is a well-tolerated and immunogenic vaccine that can be administered in adolescents previously vaccinated, in their childhood, with any of the licensed monovalent meningococcal serogroup C conjugated vaccines, including NeisVac-C. In infants as early as six weeks of age, and up to 12 months old, the recommended immunization series consists of two doses (0.5 mL each), with the first dose given from six weeks of age and with an interval of two months between doses. A booster dose is subsequently administered at 12 months of age. In individuals over 12 months of age, a single 0.5 mL dose should be administered. A second dose of Nimenrix may be considered appropriate for some individuals. Nimenrix was first approved in the EU on April 20, 2012 and is licensed in more than 65 countries, including the countries across the EU, Brazil, Chile, Kuwait, Qatar, Turkey and the UAE. The EU SmPC is available on request. Meningococcal disease can affect anyone, at any age. The reported incidence of invasive meningococcal disease (IMD) varies by region, ranging from less than 0.5 cases per 100,000 in North America and just under 1 case per 100,000 in Europe, and up to 10-1,000 cases per 100,000 during epidemic years in Africa.2 The majority of invasive meningococcal disease cases worldwide can be attributed to six Neisseria meningitidis serogroups (A, B, C, W-135, X and Y).2 Together serogroups A, C, W-135, Y and B account for 90% of all invasive meningococcal disease.3 Meningococcal disease, while rare, can be unpredictable, and occur quickly and without warning in otherwise healthy individuals.4 It can progress rapidly, and symptoms are difficult to distinguish from other more common infections, with flu-like symptoms such as headache, nausea and vomiting among the earliest signs. The most common clinical presentations of meningococcal disease are meningitis and septicemia.5 The disease can progress from initial symptoms to death within 24 hours, leaving a narrow window of opportunity to deliver life-saving treatment.6,7 Pfizer Inc.: Working together for a healthier world™ At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of December 19, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Nimenrix™ (meningococcal group A, C, W-135, and Y conjugate vaccine) and an expanded indication in the European Union, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of Nimenrix; the uncertainties inherent in research and development, as well as the possibility of unfavorable clinical trial results; whether and when any biologics license applications may be filed in any other jurisdictions for Nimenrix; whether and when regulatory authorities in any other jurisdictions where applications for Nimenrix may be pending or filed may approve any such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the immunogenicity and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Nimenrix; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 1 Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal group A, C, W and Y conjugate vaccine. Summary of Product Characteristics. 2016. 3 Kieny MP, Excier J, Girard M. Research and development of new vaccines against infectious diseases. Am J Public Health. 2004; 94(11): 1931-1935. 4 Poland GA. Prevention of meningococcal disease: current use of polysaccharide and conjugate vaccines. Clin Infect Dis. 2010; 50; S45-S53. 5 Meningitis Research Foundation. Meningococcal meningitis and septicaemia: guidance notes: diagnosis and treatment in general practice, 2014 edition. http//www.meningitis.org/assets/x/50631. Accessed March 12, 2015. 7 Thompson MJ, Ninis N, Perera R et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet 2006;367:397-403.
News Article | May 9, 2017
WASHINGTON & SAN FRANCISCO--(BUSINESS WIRE)--California Life Sciences Association (CLSA), the state’s premier public policy and business solutions organization representing the California life sciences industry, today commended the U.S. Senate’s confirmation of Scott Gottlieb, M.D., as the new commissioner of the U.S. Food and Drug Administration (FDA). As the key federal agency responsible for protecting and promoting public health by regulating drugs, medical devices, food safety and other health-related products, the FDA plays a vital role in the development of all biopharmaceuticals and medical technologies. As such, the FDA’s work heavily impacts the pace at which innovation is driven in California’s life sciences industry as well as the delivery of life-changing medicines and technologies far beyond the state of California. “On behalf of the hundreds of life sciences organizations up and down the state we embody, California Life Sciences Association applauds the confirmation of Scott Gottlieb, M.D., as FDA Commissioner. Over the span of his distinguished career, Dr. Gottlieb has a proven track record as a strong advocate for both protecting public health and promoting biomedical innovation,” said Sara Radcliffe, President and CEO, California Life Sciences Association (CLSA). “More recently, Dr. Gottlieb’s prominent and respected participation on several public health and policy committees, including the Federal Health IT Policy Committee and the National Coalition for Cancer Survivorship, further confirm the breadth and depth of his experience and commitment to bringing life-saving innovations to patients in need. During his previous time at the FDA as a deputy commissioner, Dr. Gottlieb was a strong advocate for policies that supported an efficient and streamlined drug development and approval process, including supporting development of the Critical Path Initiative. With his experience in regulatory matters, and understanding of agency and industry needs, we are confident Dr. Gottlieb will be an exemplary leader for the FDA. We look forward to working with him and his team at the FDA to meet our shared goals,” added Radcliffe. Dr. Gottlieb previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs, a position he held from 2005 to 2007. He has also served as a senior policy advisor to the Administrator at the Centers for Medicare & Medicaid Services. He is a former member of the editorial staff of the British Medical Journal (BMJ), and a member of the editorial board of the Journal of the American Medical Association (JAMA). Dr. Gottlieb is currently a clinical assistant professor at New York University School of Medicine, and a resident fellow at the conservative American Enterprise Institute. California Life Sciences Association (CLSA) is the state’s largest and most influential life sciences advocacy and business leadership organization. With offices in Sacramento, San Diego, South San Francisco, Los Angeles and Washington DC, CLSA works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow California’s life sciences economy. CLSA serves biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers throughout the Golden State. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged. Visit CLSA at www.califesciences.org, and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.
Garza D.,Pfizer |
Murphy M.,Medical and Scientific Affairs |
Tseng L.-J.,Pfizer |
Riordan H.J.,Medical and Scientific Affairs |
Biological Psychiatry | Year: 2011
Background: Varenicline is an α4β2 partial nicotinic agonist approved for smoking cessation. There have been spontaneous postmarketing reports of neuropsychiatric adverse events (NPAEs) in smokers without a history of psychiatric illness quitting with varenicline. Methods: One hundred ten smokers without history of psychiatric illness (screened by Structured Clinical Interview for DSM-IV) were randomized to 12 weeks of varenicline 1 mg twice daily (n = 55) or placebo. Adverse events were solicited systematically. Depressive symptoms, anxiety, aggression, and irritability were measured at baseline and weekly using the Montgomery-sberg Depression Rating Scale (MADRS), the Hamilton Anxiety Scale (HAM-A), and the Overt Aggression ScaleModified (OAS-M). The Profile of Mood States (POMS) was administered daily. Mixed-model analysis of repeated measures was conducted to compare mean changes in scores between groups across study periods. Results: Participants' mean baseline characteristics were 33 years of age, 22 cigarettes/day and Fagerstrm Test for Nicotine Dependence score > 7. Reported NPAEs were similar between groups. No suicidal events were reported. There were no significant differences between groups for the MADRS (treatment difference vs. placebo = .03, 95% confidence interval [CI] -.68.73; NS), HAM-A (treatment difference [TD] = .14, 95% CI -.62.90; NS), OAS-M Aggression subscale (TD = .5, 95% CI -1.182.18; NS), OAS-M Irritability subscale (TD = .08, 95% CI -.17.34; NS), and the POMS total scores (TD = .5, 95% CI -.521.53; NS). Conclusions: There were no significant differences between groups on measures of depressive symptoms, anxiety, or aggression/hostility. Systematically solicited NPAEs were similar between the varenicline and placebo groups. © 2011 Society of Biological Psychiatry.
News Article | February 27, 2017
TUCSON, Ariz., Feb. 27, 2017 /PRNewswire/ -- More than 500 pathologists, oncologists, scientific researchers and healthcare leaders will converge in Tucson for the 13th annual Tucson Symposium, February 28 to March 1. The two-day conference, which is sponsored by Ventana Medical Systems, Inc., a member of the Roche Group, draws top scientific collaborators from around the globe to hear from leading experts about the latest hypotheses, breakthroughs and innovations in cancer research and treatments. Topics will focus on developments in immunotherapy, genomics, technology, tumor heterogeneity and cancer evolution and personalized healthcare. Tucson Symposium was conceived in 2005 by Ventana Medical Systems, Inc. Founder and Senior Vice President of Scientific Affairs Dr. Thomas Grogan to provide a forum for thought leaders to share scientific advancements in cancer research and medical practice. "We are extremely pleased to announce that our distinguished opening keynote speaker this year is Dr. Antoni Ribas, a leading oncologist who will speak to advances in revolutionary new immune blockade therapy," Grogan said. Ribas, who is a Professor of Medicine, Professor of Surgery and Professor of Molecular and Medical Pharmacology at the University of California at Los Angeles (UCLA), will deliver information on the unprecedented response to this new therapy in patients with multiple metastatic cancers as well as combination approaches to improving treatment options. Charles Swanton, PhD, of London's Francis Crick Institute – a leading expert on heterogeneity and cancer's drug resistant and incurable nature – will return to the Symposium for a third year to deliver the Day 2 keynote address on our expanding knowledge of tumor genetic heterogeneity. Other sessions stretch beyond the traditional bounds of pathology to include discussions on genomics and innovative technologies that are transforming the field, including novel, emerging multiplexing technologies. "Having hosted the Tucson Symposium for 13 years, we've reached a pinnacle in terms of the experts delivering content on a broad range of cancer-related topics," said Dr. Eric Walk, a pathologist who is Senior Vice President, Medical and Scientific Affairs, and Chief Medical Officer at Ventana Medical Systems, Inc. "They are imparting the most current, critical knowledge that will enrich and advance the field of medicine and scientific research." For more information on Tucson Symposium, held at the Hilton Tucson El Conquistador, please visit www.ventana.com/tucson-symposium/. About Ventana Medical Systems, Inc. Ventana Medical Systems, Inc. (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA products are used in clinical histology and drug development research laboratories worldwide. The company's intuitive, integrated staining, workflow management platforms and digital pathology solutions optimize laboratory efficiencies to help reduce errors, support diagnosis and enable informed treatment decisions by anatomic pathology professionals. Together with Roche, Ventana is driving Personalized Healthcare through accelerated drug discovery and the development of companion diagnostics to identify the patients most likely to respond favorably to specific therapies. Visit www.ventana.com. All trademarks used or mentioned in this release are protected by law.
News Article | July 12, 2016
Zika Virus - What You Should Know Ticked Off! Here's What You Need To Know About Lyme Disease The U.S. Food and Drug Administration (FDA) has expanded the use of the best-selling pneumonia vaccine Prevnar 13, its producer Pfizer Inc. revealed in a statement released on Tuesday. The vaccine, which provides protection against 13 strains of the streptococcus pneumoniae bacteria that cause pneumonia and other diseases, has previously been granted approval for use by children between 6 and 17 years old and adults who are over 50 years old. The new approval now greenlights the use of the vaccine in infants, young children and adults who are 18 years old or older. Pneumococcal pneumonia, which occurs when the streptococcus pneumoniae infects the lungs, is the most common serious form of disease caused by the bacterium in adults. Its symptoms include fever and chills, difficulty breathing, cough and chest pain. Older adults may experience low alertness and confusion. According to the U.S. Centers for Disease Control and Prevention (CDC), about five in 100 people with non-invasive pneumococcal pneumonia will die from it albeit the rate could be higher in elderly patients. "This expanded age indication in adults 18 to 49 offers an important public health benefit as appropriate vaccination against S. pneumoniae is critical to reducing the risk of pneumococcal disease, including in those with immunocompromising conditions," said Pfizer Vaccines Chief Medical and Scientific Affairs Officer Luis Jodar in a statement. The health regulators' decision is based on the results of a late stage study, which involved adults who had not been vaccinated against pneumonia previously. The study published in the journal Vaccine in October 2015, compared the safety, tolerability and immunogenicity of the vaccine in adults who were between 18 and 49 years of age with adults who were between 60 and 64 years old, for whom use of the Prevnar vaccine was already approved. The FDA's decision makes Prevnar the only pneumococcal vaccine approved in the United States for patients beginning at 6 weeks old through adulthood. Common side effects of the vaccine in adults include pain, swelling, or redness at the injection site, limited arm movement, fatigue, vomiting, headache, muscle pain, joint pain, reduced appetite, chills, or rash. In children age 6 weeks to 17 years, common side effects include tenderness, swelling, or redness at the injection site, irritability, reduced appetite, shorter or longer sleep, and fever. The vaccine is part of the immunization program of over 100 countries worldwide.It has grossed an annual sales of $6.25 billion in 2015, higher by 40 percent from 2014, helping buoy Pfizer's revenue. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.
News Article | February 27, 2017
BOSTON, Feb. 27, 2017 (GLOBE NEWSWIRE) -- Exonics Therapeutics, Inc., a newly formed biotechnology company focused on developing gene editing technologies like CRISPR/Cas9 to permanently correct a majority of mutations causing Duchenne muscular dystrophy and other neuromuscular diseases, today announced a commitment of $5 million in seed financing from CureDuchenne Ventures, LLC, a subsidiary of the nonprofit CureDuchenne. The initial seed funding will allow Exonics to advance the preclinical research of its scientific founder and chief science advisor Eric Olson, PhD. Dr. Olson’s laboratory has demonstrated the ability to use adeno-associated virus (AAV) to deliver a payload based on CRISPR/Cas9 technology that can identify and correct exon mutations that prevent the production of dystrophin, a protein that helps stabilize and protect muscle fibers. Dystrophin is the key protein missing in boys with Duchenne, and published preclinical data suggest that this approach has the potential to permanently treat up to 80 percent of children suffering from the disease. Additional preclinical data is expected to be published in March 2017. “This represents the next generation of potential Duchenne muscular dystrophy therapies. By leveraging the revolutionary CRISPR/Cas9 method to permanently correct errors in the DNA sequence, it is our hope that we can develop a one-time therapy that provides lifelong benefit to Duchenne patients,” said Dr. Olson, who also serves as Professor and Chairman of the Department of Molecular Biology at the University of Texas Southwestern Medical Center (UTSW), from which Exonics’ technology is licensed. Duchenne is a rare X-linked genetic progressive muscle disease affecting nearly 15,000 boys in the U.S. and more than 300,000 boys worldwide. There is no cure for Duchenne. Children with the disease start missing development milestones at age 3 and often lose their ability to walk by age 12. All Duchenne patients will suffer from reduced mobility and independence, and ultimately respiratory or cardiac failure results in a reduced life expectancy in the mid-20s. “We are building on a scientific program of exceptional quality from Dr. Olson’s laboratory with the support of our funder CureDuchenne Ventures, an organization with deep understanding of this disease, therapeutic landscape and large unmet need. This funding underscores their recognition of the potential of Exonics’ gene editing method to develop a novel therapy for Duchenne,” said Cristina Csimma, PharmD, MHP, Executive Chair of the Board of Directors of Exonics, former President and Chief Executive Officer of Cydan, and long-time drug development leader. “Exonics is extremely well-positioned to advance our preclinical program as we follow a rigorous approach to enable translation to clinical trials.” “We look forward to working closely with the Duchenne community as we aggressively advance gene editing technology to address the significant unmet need for a curative therapy that would dramatically improve the lives of patients with Duchenne and their families,” said Jak Knowles, MD, President and Interim Chief Executive Officer of Exonics. “We are honored to advance the groundbreaking work of Dr. Olson’s laboratory and are eager to translate this approach into an important therapy for the Duchenne community.” Dr. Knowles will continue to serve the Duchenne community as Managing Director of CureDuchenne Ventures, and VP of Medical and Scientific Affairs at CureDuchenne. “We are delighted to support Dr. Olson and the Exonics team as they advance novel gene editing technology toward a potential cure for Duchenne. CureDuchenne Ventures’ unique model enables us to share our significant scientific resources, expertise and deep connections with the Duchenne community to accelerate scientific breakthroughs, such as Exonics’ program,” said Debra Miller, President of CureDuchenne Ventures and Founder and Chief Executive Officer of CureDuchenne. About Exonics Therapeutics Exonics Therapeutics is advancing gene editing technologies like CRISPR/Cas9 to permanently correct the majority of Duchenne muscular dystrophy mutations. Preclinical data suggest Exonics’ novel gene editing approach has the potential to permanently treat up to 80 percent of children who suffer from Duchenne. Exonics’ technology is licensed from the University of Texas Southwestern Medical Center and is based on the research of its scientific founder and chief science advisor, Eric Olson, PhD. The Company’s corporate office is located in Boston, Mass., and research activities are being conducted in Dallas, Tex. For more information, please visit www.exonicstx.com. CureDuchenne Ventures LLC collaborates with pharmaceutical and biotechnology companies to facilitate the development of drugs to treat Duchenne muscular dystrophy. CureDuchenne Ventures LLC was formed by CureDuchenne, a national nonprofit that has funded nine research projects that have advanced to human clinical trials.
News Article | February 22, 2017
LINCOLN, Neb.--(BUSINESS WIRE)--Celerion continues to grow in response to the evolving needs of early clinical research. With the increasing focus on evaluating drug effects in relevant patient populations earlier in development, Celerion is pleased to announce that Dr. Marc Hoffman has joined the company as Chief Medical Officer. Dr. Hoffman will have responsibility for leading the global medical staff and providing medical oversight and expertise to support early clinical research studies. Dr. Hoffman joins Celerion from Patient iP where he served as Chief Medical Officer, providing clinical leadership around Patient iP’s innovative platform, customer programs and related medical affairs activities. Prior to joining Patient iP, he held the roles of Chief Medical Officer and Senior Vice President and General Manager over the Biopharmaceutical Business at Theorem Clinical Research, leading the development of drugs and biologics. Previously in his career, Dr. Hoffman held positions of increasing responsibility in Medical and Scientific Affairs at Baxter, Hospira and Covance, providing senior-level strategic direction for Phase II-IV programs. Dr. Hoffman brings over 28 years of knowledge and experience as a physician in the pharmaceutical, device, and CRO industries to this role. He is experienced in global drug development, medical affairs, pharmacovigilance and regulatory affairs, and has a proven track record in building, managing and globalizing medical teams. “We are pleased to have Marc join our executive leadership team during this exciting period of growth in our company,” said Susan Thornton PhD, President and CEO. “His depth of experience in managing all aspects of global drug development in multiple therapeutic areas will not only make him a valuable asset for our organization but also for our clients.” Translating science into medicine, Celerion is a premier provider of early clinical research and translational clinical pharmacology sciences from their global locations in North America, Europe and Asia. Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and clinical pharmacology research supporting product labeling. With purpose built clinic and laboratory facilities and highly automated technology, Celerion provides full study services including clinical study conduct, data management and biometrics, PK/PD analysis, bioanalytical services, medical writing, and regulatory and drug development program management. For more information please visit www.celerion.com.