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Kramer M.F.,Bencard Allergie GmbH | Heath M.D.,Allergy Therapeutics
Vaccine | Year: 2014

We are living in an "aluminium age" with increasing bioavailability of the metal for approximately 125 years, contributing significantly to the aluminium body burden of humans. Over the course of life, aluminium accumulates and is stored predominantly in the lungs, bones, liver, kidneys and brain. The toxicity of aluminium in humans is briefly summarised, highlighting links and possible causal relationships between a high aluminium body burden and a number of neurological disorders and disease states.Aluminium salts have been used as depot-adjuvants successfully in essential prophylactic vaccinations for almost 100 years, with a convincing positive benefit-risk assessment which remains unchanged.However, allergen-specific immunotherapy commonly consists of administering a long-course programme of subcutaneous injections using preparations of relevant allergens. Regulatory authorities currently set aluminium limits for vaccines per dose, rather than per treatment course. Unlike prophylactic vaccinations, numerous injections with higher proportions of aluminium-adjuvant per injection are applied in subcutaneous immunotherapy (SCIT) and will significantly contribute to a higher cumulative life dose of aluminium. While the human body may cope robustly with a daily aluminium overload from the environment, regulatory cumulative threshold values in immunotherapy need further addressing. Based on the current literature, predisposing an individual to an unusually high level of aluminium, such as through subcutaneous immunotherapy, has the potential to form focal accumulations in the body with the propensity to exert forms of toxicity. Particularly in relation to longer-term health effects, the safety of aluminium adjuvants in immunotherapy remains unchallenged by health authorities - evoking the need for more consideration, guidance, andtransparency on what is known and not known about its safety in long-course therapy and what measures can be taken to prevent or minimise its risks. The possibility of providing an effective means of measuring aluminium accumulation in patients undergoing long-term SCIT treatment as well as reducing their aluminium body burden is discussed. © 2014 The Authors.

Chen H.-M.,National Yang Ming University | Chen H.-M.,Academia Sinica, Taiwan | Wang P.-H.,Academia Sinica, Taiwan | Chen S.-S.,Academia Sinica, Taiwan | And 10 more authors.
Cancer Immunology, Immunotherapy | Year: 2012

Immunogenic cell death is characterized by damage-associated molecular patterns, which can enhance the maturation and antigen uptake of dendritic cells. Shikonin, an anti-inflammatory and antitumor phytochemical, was exploited here as an adjuvant for dendritic cell-based cancer vaccines via induction of immunogenic cell death. Shikonin can effectively activate both receptorand mitochondria-mediated apoptosis and increase the expression of all five tested damage-associated molecular patterns in the resultant tumor cell lysates. The combination treatment with damage-associated molecular patterns and LPS activates dendritic cells to a high maturation status and enhances the priming of Th1/Th17 effector cells. Shikonin-tumor cell lysate-loaded mature dendritic cells exhibit a high level of CD86 and MHC class II and activate Th1 cells. The shikonin-tumor cell lysate-loaded dendritic cell vaccines result in a strong induction of cytotoxic activity of splenocytes against target tumor cells, a retardation in tumor growth, and an increase in the survival of test mice. The much enhanced immunogenicity and efficacy of the current cancer vaccine formulation, that is, the use of shikonin-treated tumor cells as cell lysates for the pulse of dendritic cells in culture, may suggest a new ex vivo approach for developing individualized, dendritic cells-based anticancer vaccines. © Springer-Verlag 2012.

Patel P.,Allied Research International | Patel P.,3121 Universal Dr | Holdich T.,Allergy Therapeutics | Fischer Von Weikersthal-Drachenberg K.J.,Bencard Allergie | And 2 more authors.
Journal of Allergy and Clinical Immunology | Year: 2014

Background Specific immunotherapy acts to modify the underlying cause of allergic rhinoconjunctivitis. Addition of adjuvants, such as monophosphoryl lipid A (MPL), might allow for efficacious and safe treatment with only 4 injections administered preseasonally, which is in contrast to most available schedules requiring long injection courses. Objective The primary objective was to assess the clinical efficacy of Ragweed MATA MPL (short ragweed pollen allergoid adsorbed to L-Tyrosine + MPL) versus placebo in reducing allergic rhinoconjunctivitis symptoms caused by ragweed pollen in an environmental exposure chamber (EEC) 3 weeks after treatment. Methods This was a randomized, double-blind, placebo-controlled phase IIb study to evaluate the clinical efficacy and safety of Ragweed MATA MPL compared with placebo by using controlled ragweed pollen exposure in an EEC. Two hundred twenty-eight patients with a history of ragweed allergy and positive skin prick test responses to ragweed were randomized and received 4 weekly injections of active treatment or placebo. Total nasal and nonnasal symptom scores were obtained in the EEC before and after treatment. Results Mean improvement in total symptom scores in the Ragweed MATA MPL group was statistically significantly greater than in the placebo group (relative mean improvement of active vs placebo, 48%; P <.05; median improvement, 82%). The majority of adverse events (AEs) experienced by subjects were mild injection-site reactions. No severe systemic AEs or serious AEs occurred during the study. Conclusion This study demonstrated that an ultrashort course of Ragweed MATA MPL is efficacious in reducing allergy symptoms in patients with seasonal allergic rhinitis and that it is well tolerated. © 2013 American Academy of Allergy, Asthma & Immunology.

Allergy Therapeutics | Date: 2014-12-11

Pharmaceutical and veterinary preparations, in particular vaccines, allergy vaccines, and preparations for immunotherapy; Sanitary preparations for medical purposes; Dietetic food and substances adapted for medical or veterinary use, food for babies; Dietary supplements for humans and animals; Plasters, materials for dressings; Material for stopping teeth, dental wax; Disinfectants; Preparations for destroying vermin; Fungicides, herbicides; All the aforesaid goods other than for ophthalmological purposes.

News Article | March 12, 2015
Site: www.fiercebiotech.com

Allergy Therapeutics (AIM:AGY) has turned to public investors for £20 million ($30 million) to move its subcutaneous immunotherapy allergy vaccine through late-phase development. The cash will fund Allergy Therapeutics' attempt to bounce back from the 5-year clinical hold of its U.S. trial program. The FDA initiated the clinical hold on Pollinex Quattro Grass in 2007 after a trial participant reported numbness and weakness. At the time, the regulator was particularly concerned about the side effects of novel adjuvants and took until 2012 to lift the hold. Worthing, United Kingdom-based Allergy Therapeutics had hoped getting the regulatory green light would enable it to snag a partner to commercialize the vaccine in the U.S., but three years later it is still flying solo. Now, with the FDA reviewing Allergy Therapeutics' protocol and statistical analyses, the U.S. clinical trial program is on the cusp of getting back on track. And despite the delays, Allergy Therapeutics thinks there is still pent up demand for its grass vaccine in the country. "We have the opportunity to be the first FDA-licensed seasonal subcutaneous immunotherapy allergy vaccine, and so access an estimated $2 billion market," Allergy Therapeutics CEO Manuel Llobet said in a statement. To reach that point, Allergy Therapeutics has placed enough shares to net it the £20 million it needs for the clutch of studies requested by the FDA. An environmental exposure chamber Phase III efficacy trial--which puts participants in contact with allergens--and a patient registry study are requirements of the biological licence application. Allergy Therapeutics also plans to run safety and pilot studies to assess the dosing of Pollinex Quattro Grass. If everything goes according to plan, Allergy Therapeutics will begin selling Pollinex Quattro Grass in the U.S. in 2019 and become a financially self sustaining business. Since going public in 2004, Allergy Therapeutics has raised cash through placements several times, one of which saw Chile-based CFR Pharmaceuticals become the majority shareholder. CFR was bought out by Abbott Laboratories ($ABT) last year, making the healthcare giant the controlling shareholder in Allergy Therapeutics. Related Articles: FDA lifts hold on Allergy Therapeutics' grass pollen allergy vax Allergy Therapeutics shares spike on late-stage data Allergy Therapeutics afflicted by FDA's move to halt trials

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