Nabi Biopharmacetuicals is a drug development company in Rockville, Maryland.Its principle product is NicVAX , a nicotine conjugate vaccine intended to reduce physical addiction to nicotine.The drug was developed with help from the U.S. National Institute of Drug Abuse, and showed promise in early studies, however, two successive phase III trials of the drug in 2009 and 2011 failed.On Thursday, November 8, 2012 the business combination of Nabi Biopharmaceuticals and Biota Holdings Limited became effective to create Biota Pharmaceuticals, Inc. Wikipedia.
Hatsukami D.K.,University of Minnesota |
Jorenby D.E.,University of Wisconsin - Madison |
Gonzales D.,Oregon Health And Science University |
Rigotti N.A.,Massachusetts General Hospital |
And 10 more authors.
Clinical Pharmacology and Therapeutics | Year: 2011
NicVAX, a nicotine vaccine (3′AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence rates and whether dosages and frequency of administration are associated with increased Ab response. This randomized, double-blinded, placebo-controlled multicenter clinical trial (N = 301 smokers) tested the results of 200- and 400-νg doses administered four or five times over a period of 6 months, as compared with placebo. 3′AmNic-rEPA recipients with the highest serum antinicotine Ab response (top 30% by area under the curve (AUC)) were significantly more likely than the placebo recipients (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14-6.37) to attain 8 weeks of continuous abstinence from weeks 19 through 26. The five-injection, 400-μg dose regimen elicited the greatest Ab response and resulted in significantly higher abstinence rates than placebo. This study demonstrates, as proof of concept, that 3′AmNic-rEPA elicits Abs to nicotine and is associated with higher continuous abstinence rates (CAR). Its further development as a treatment for nicotine dependence is therefore justified.
The efficacy and safety of a nicotine conjugate vaccine (NicVAX®) or placebo co-administered with varenicline (Champix®) for smoking cessation: Study protocol of a phase IIb, double blind, randomized, placebo controlled trial
Hoogsteder P.H.,Maastricht University |
Kotz D.,Maastricht University |
Van Spiegel P.I.,Nabi Biopharmaceuticals |
Viechtbauer W.,Maastricht University |
And 5 more authors.
BMC Public Health | Year: 2012
Background: A potential new treatment in smoking cessation and relapse prevention is nicotine vaccination which is based on active immunization against the nicotine molecule. This immunization will elicit the immune system to produce nicotine-specific antibodies that sequester nicotine in the blood stream, after inhaling tobacco products. The resulting antibody-antigen is too large to cross the blood-brain barrier and is therefore postulated to attenuate the rewarding effect of nicotine by preventing the latter from reaching its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine NicVAX® co-administered with varenicline (Champix®) and intensive counseling as an aid in smoking cessation and relapse prevention. Methods/design. Two centers will include a total of 600 smokers who are motivated to quit smoking. At week -2 these smokers will be randomized, in a 1:1 ratio, to either 6 injections of NicVAX® or placebo, both co-administered with 12-weeks of varenicline treatment, starting at week 0. The target quit day will be set after 7 days of varenicline treatment at week 1. Smokers will be followed up for 54 weeks. The primary outcome is defined as biochemically validated prolonged smoking abstinence from week 9 to 52. Secondary outcomes include safety, immunogenicity, smoking abstinence from week 37 to 52, abstinence from week 9 to 24, abstinence in the subset of subjects with the highest antibody response, and lapse/relapse rate. Discussion. This is the first study to assess the efficacy of a nicotine conjugate vaccine in combination with an evidence-based smoking cessation pharmacotherapy (varenicline) to quit smoking. Although NicVAX® is primarily designed as an aid to smoking cessation, our study is designed to explore its potential to maintain abstinence and prevent relapse. The results of this trial will give a unique insight in the potential of nicotine vaccination for relapse prevention. Trial registration. ClinicalTrials.gov: (NCT00995033). © 2012 Hoogsteder et al.; licensee BioMed Central Ltd.
Marr J.,Bayer AG |
Niknian M.,Nabi Biopharmaceuticals |
Shulman L.P.,Northwestern University |
Lynen R.,Bayer AG
Contraception | Year: 2011
Background: A combined oral contraceptive comprising ethinylestradiol (EE) 20 mcg/drospirenone 3 mg in a 24/4 regimen has been clinically shown to alleviate the symptoms associated with premenstrual dysphoric disorder (PMDD). However, previous studies did not report data according to cycle-by-cycle improvement. Study design: This was a subanalysis of a Phase III, double-blind, multicenter, United States-based study. Women with confirmed PMDD were randomized to EE 20 mcg/drospirenone 3 mg 24/4 or placebo for three treatment cycles. Ten of the 21 emotional and physical items on the Daily Record of Severity of Problems scale were grouped to define three symptom clusters: (a) negative emotions, (b) food cravings and (c) water retention-related symptoms. The change from baseline at each treatment cycle was compared between groups using a weighted analysis of covariance model. Results: The full analysis set comprised 449 women. Daily Record of Severity of Problems scores for each symptom cluster were significantly reduced from baseline with both EE 20 mcg/drospirenone 3 mg 24/4 and placebo (p<.0001 for all). The greatest symptom improvements were achieved within the first cycle of treatment and continued throughout cycles 2 to 3. The mean between-treatment difference was significant in favor of EE 20 mcg/drospirenone 3 mg 24/4 for all three symptom clusters in all three treatment cycles (p≤.0001 vs. placebo in percent change from baseline). Conclusion: Ethinylestradiol 20 mcg/drospirenone 3 mg 24/4 improved commonly recognizable PMDD symptom clusters relating to negative emotions, food cravings and water retention-related symptoms to a significantly greater extent than placebo during all three cycles of treatment. © 2011 Elsevier Inc. All rights reserved.
Fahim R.E.F.,Nabi Biopharmaceuticals |
Kessler P.D.,Nabi Biopharmaceuticals |
Fuller S.A.,Nabi Biopharmaceuticals |
Kalnik M.W.,Nabi Biopharmaceuticals
CNS and Neurological Disorders - Drug Targets | Year: 2011
Smoking is a global healthcare problem. Current smoking cessation rates using behavioral counseling and pharmacotherapeutic interventions have had modest success, with ~1:5 smokers remaining abstinent long-term. Nicotine vaccines are a new class of immunotherapeutics under development. It is believed that anti-nicotine antibodies arising from vaccination capture nicotine and prevent or reduce its entry into the brain, as the antibody-bound nicotine is too large to cross the blood-brain barrier. This in turn decreases the pleasurable effects of smoking, reducing or eliminating positive reinforcement, thereby making it easier for a smoker to quit smoking. Four vaccine candidates have advanced into clinical testing with mixed success. Proof-of-concept has been established in that individuals with higher levels of anti-nicotine antibodies were observed to have higher smoking cessation and abstinence rates. Recently, the most advanced candidate vaccine, NicVAX, failed to meet the primary endpoint in two large phase III studies, although the correlation of higher abstinence rates in subjects with higher immunity to nicotine was observed. Although the field has had setbacks, the magnitude of the tobacco epidemic and the positive pre-clinical research and observed clinical trends indicate continued research is warranted. Several avenues are being actively pursued: a) improving vaccine potency by introducing novel carriers and/or adjuvants to stimulate higher immune response b) targeting subjects who have a robust response (e.g. personalized medicine) c) combining vaccines with pharmacotherapy for maintenance of abstinence/relapse prevention. © 2011 Bentham Science Publishers.
Fahim R.E.,Nabi Biopharmaceuticals |
Kessler P.D.,Nabi Biopharmaceuticals |
Kalnik M.W.,Nabi Biopharmaceuticals
Expert Review of Vaccines | Year: 2013
Most smokers are aware of the dangers of smoking and want to quit, yet few are successful owing to the highly addictive properties of nicotine. Available smoking cessation tools include pharmacotherapies that act in the CNS and show modest long-term efficacy. Additionally, there are emerging concerns that they may cause adverse neuropsychiatric events. Antinicotine vaccines have been used experimentally as aids to smoking cessation. It is hypothesized that antibody capture of nicotine in the bloodstream would prevent it from crossing the blood-brain barrier and reaching the nicotinic receptors. The advantage of the approach includes the relatively gradual rise of antibody levels, which may reduce nicotine withdrawal symptoms, and the possible persistence of the antibodies potentially provides long-term protection, possibly preventing relapse. Proof-of-concept studies of at least two vaccine candidates have shown correlations between antinicotine antibody exposure and smoking abstinence. Unfortunately, the only vaccine tested in two large, randomized Phase III trials, 3'-amino-methyl-nicotine r-exoprotein A conjugate vaccine (NicVAX ®, Nabi Biopharmaceuticals, MD, USA), did not demonstrate efficacy. However, despite the lack of efficacy, there is good reason for continued optimism. This review will summarize the current status of the development of nicotine vaccines, discuss possible causes for the mixed results and review future scientific directions. © 2013 2013 Expert Reviews Ltd.
Nabi Biopharmaceuticals | Date: 2011-05-25
Novel hapten-carrier conjugates are capable of inducing the production of antibodies, in vivo, that specifically bind to nicotine. These conjugates comprise a nicotine hapten conjugated to an immunogenic carrier protein. The novel conjugates preserve the chirality of nicotine in its native (S)-(-) state, and have good stability properties. The conjugates are useful in formulating vaccines for active immunization, that are used to prevent and treat nicotine addiction. The antibodies raised in response to the nicotine hapten-carrier conjugate are used for passive immunization. These antibodies are administered for prevention and treatment of nicotine addiction.
Nabi Biopharmaceuticals | Date: 2011-01-05
The invention concerns an isolated Enterococcus faecium antigen comprising 2-acetamido-2-deoxy-galactose and galactose, in particular one which reacts with antibodies to ATCC 202015. Furthermore an antigen-carrier conjugate comprising the antigen bonded to an immunocarrier; a composition comprising such an antigen and a carrier; and an immune globulin containing antibodies directed against such antigens and a carrier.
Nabi Biopharmaceuticals | Date: 2011-12-21
PubMed | University of Toledo, Naval Medical Center Portsmouth, Nabi Biopharmaceuticals, Uniformed Services University of the Health Sciences and San Antonio Military Medical Center
Type: | Journal: Human vaccines & immunotherapeutics | Year: 2016
We conducted a randomized, double-blind, placebo-controlled dose-escalation study in healthy adults to evaluate the safety and immunogenicity of recombinant Staphylococcus aureus candidate vaccine antigens, recombinant -toxoid (rAT) and a sub-unit of Panton-Valentine leukocidin (rLukS-PV). 176 subjects were enrolled and randomized within 1 of 11 treatment cohorts: monovalent rAT or rLukS-PV dosages of 10, 25, 50, and 100g; bivalent rAT:rLukS dosages of 10:10, 25:25, and 50:50g; and alum or saline placebo. All subjects were assessed at Days 0, 7, 14, 28, and 84. Subjects in the 50:50g bivalent cohort received a second injection on Day 84 and were assessed on Days 98 and 112. Incidence and severity of reactogenicity and adverse events (AEs) were compared. Geometric mean serum concentrations (GMC) and neutralizing activity of anti-rAT and anti-rLukS-PV IgG were assessed. Reactogenicity incidence was significantly higher in vaccine than placebo recipients (77% versus 55%, respectively; p = 0.006). However, 77% of reactogenicity events were mild and 19% were moderate in severity. The AE incidence and severity were similar between the cohorts. All monovalent and bivalent rAT dosages resulted in a significant increase in the anti-rAT IgG and anti- rLukS-PV GMCs between day 0 and 28 compared with placebo, and persisted through Day 84. Exploratory subgroup analyses suggested a higher GMC and neutralizing antibody titers for the 50g monovalent or bivalent rAT and rLukS-PV dose as compared to the other doses. No booster effect was observed after administration of the second dose. We conclude that the rAT and rLukS-PV vaccine formulations were well-tolerated and had a favorable immunogenicity profile, producing antibody with neutralizing activity through day 84. There was no benefit observed with a booster dose of the vaccine.