AIDS-Related Complex

BAAR, Switzerland--(BUSINESS WIRE)-- Stallergenes Greer, a biopharmaceutical company specialising in the diagnosis and treatment of respiratory allergies, announced today the initiation of a Phase III clinical study (YOBI, YOung patients and BIrch allergy) to confirm the safety and efficacy of Staloral® Birch in children and adolescents with birch pollen-induced allergic rhino-conjunctivitis with or without asthma. The randomised, double-blind placebo-controlled Phase III study will involve approximately 80 sites in 12 European countries. Allergic rhino-conjunctivitis is a worldwide disease and a global health burden affecting more than 500 million people, who are at higher risk of developing rhinitis exacerbation and asthma than the general population1..Birch is among the strongest allergy-producing trees in northern Europe. The allergic potential of other trees belonging to the birch homologous group, such as alder and hazel, is also increasing steadily2. In children and adolescents, allergic rhino-conjunctivitis can lead to sleep problems, fatigue, missed school days and can complicate outdoor activities3. Individuals sensitised at a young age are also more at risk of developing asthma. The younger the children are, the higher their risk of developing asthma, which highlights the relevance of early causal treatment in paediatric patients to slow the worsening of allergy symptoms4. Allergen immunotherapy (AIT) is currently the only available therapeutic treatment that has the potential to uniquely alter the natural course of the disease5. In its liquid form, sublingual AIT can provide a needle-free and flexible treatment for children and adolescents. “Allergic rhino-conjunctivitis induced by birch and related trees can lead to a spiraling of respiratory symptoms and conditions in the paediatric population. The YOBI study will contribute to addressing a global health burden, while deepening our knowledge of AIT with the aim of improving patient outcomes for children and adolescents with birch-induced allergies,” said Professor Oliver Pfaar, International Coordinator of the YOBI study, Head of Rhinology and Allergy, Department of Otorhinolaryngology, Philipps-Universität Marburg, Germany. “Stallergenes Greer’s AIT treatments have proven their efficacy and safety in both clinical trials and the real world,” stated Michele Antonelli, CEO of Stallergenes Greer. “This paediatric Phase III study, illustrates our determination to further develop evidence-based solutions and build on robust datasets and cutting-edge research technologies to advance precision medicine combined with dose adaptation for the benefit of patients with allergies, the medical community, and health systems.” ABOUT STALORAL® Staloral® is a sublingual solution of allergen extracts for AIT. It is indicated in the treatment of seasonal or perennial allergic rhinitis, rhino-conjunctivitis and mild to moderate allergic asthma in adults and, in certain territories, in the paediatric population (children over 5 years of age). Clinical evidence of the efficacy of Staloral® is globally consistent over the clinical studies Stallergenes Greer conducted versus placebo. The effectiveness of Staloral® as a causal treatment for allergic rhino-conjunctivitis beyond clinical trials was also assessed by Stallergenes Greer’s real-world studies EfficAPSI and BREATH (Bringing Real-World Evidence to Allergy Treatment for Health). ABOUT ALLERGIC RHINITIS/ALLERGIC RHINO-CONJUNCTIVITIS Allergic rhinitis/allergic rhino-conjunctivitis (AR/ARC) is a chronic disorder of the upper airways that is caused by allergen exposure and the resulting IgE-mediated inflammation of the nose and, to a less extent, the eyes. Allergic rhinitis can notably include symptoms such as sneezing, a runny nose, wheezing, cough, itching, and watery/itchy eyes. Symptoms may be severe and significantly impact the patient’s quality of life, as well as worsen over time with progression towards asthma4. First intention symptomatic treatments such as antihistamines and nasal corticosteroids provide temporary relief to patients. The primary therapeutic goals of AIT include reducing symptoms, reducing symptomatic medication use, and improving allergy-related quality of life. AIT achieves these goals and can alter the course of the disease, with benefits persisting in many patients for several years after treatment discontinuation6. ABOUT STALLERGENES GREER INTERNATIONAL AG Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of allergies through the research, development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit . 1. Bousquet, J., et al., Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy, 2008. 63 Suppl 86: p. 8-160. 2. Biedermann, T., et al., Birch pollen allergy in Europe. Allergy, 2019. 74(7): p. 1237-1248. 3. Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC. A survey of the burden of allergic rhinitis in Europe. Allergy. 2007;62 Suppl 85:17-25. doi:10.1111/j.1398-9995.2007.01549.x 4. Klimek, L., et al., ARIA guideline 2019: treatment of allergic rhinitis in the German health system. Allergo journal international, 2019. 28(7): p. 255-276. 5. Roberts G, Pfaar O, Akdis CA, et al. EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis. Allergy. 2018;73(4):765-798. doi:10.1111/all.13317 6. Hesse, L., et al., Allergen immunotherapy for allergic airway diseases: Use lessons from the past to design a brighter future. Pharmacology & Therapeutics, 2022: p. 108115.

SALT LAKE CITY, Aug. 17, 2022 /PRNewswire/ -- Xenocor, a Utah-based medical device company, today announced newly issued U.S. patent protection for the Saberscope system from the United States Patent and Trademark Office (USPTO). The Saberscope system is the world's first true HD, fog free, omnidirectional articulating, recyclable laparoscope. Continue Reading With the Saberscope's innovative and disposable design, it sets itself apart from all other laparoscopes on the market today. All traditional laparoscopes present unnecessary patient risk, hassles, cost, workflow complexity and waste. Not only do they expose patients to potential cross contamination, they are also a leading source of OR fires and arc injuries. They provide inconsistent visualization due to aging components, fog and smoke and steam. They are all prone to fogging and have a limited visual field due to lack of articulation. They require substantial upfront capital costs. They require long setup procedures and complex logistics to be cleaned. Lastly, they produce significant waste in their cleaning process. "The Saberscope system is the world's first true HD, fog free, omnidirectional articulating, recyclable laparoscope." Tweet this The Saberscope system addresses every one of these challenges. It is a disposable 5mm scope, so there is no risk of cross contamination. It is non-conducting and does not get hot enough to initiate combustion. It is brand new out of the box every time, is completely fog free and sees better through smoke and steam. It articulates to 90 degrees in every direction, requires little to no capital costs and requires no complex setup or sterilization logistics. Lastly, it is recyclable and creates less landfill and water waste than traditional scopes. "Additional patent protection supports Xenocor's innovative design, assembly, system, utility, and use," said Charles DeCoster IV, Chief Executive Officer. "Xenocor's novel technology has the potential to significantly improve laparoscopic surgery and bring minimally invasive technology into the 21st century." The Saberscope system is FDA cleared for use in laparoscopic and thoracoscopic surgery. Xenocor's devices have been used in over 300 live human cases. Xenocor is a privately held company that designs, develops, and commercializes medical devices including the Saberscope system. Xenocor has 11 combined issued and pending U.S. and global patents. View product video here: Live procedures footage here: Xenocor contact: (844) 936-6267; [email protected]. SOURCE Xenocor, Inc.

Hong Kong-based biotechnology firm Ascletis has commenced a Phase II trial in China for its candidate drug ASC22 (envafolimab) in combination with antiretroviral therapy (ART), which it is developing for the functional cure and immune restoration of human immunodeficiency virus 1 (HIV-1) infection. ASC22 is being studied alongside ART with the goal of restoring virus-specific immune responses in people living with chronic viral infection. Aside from potentially curing HIV-1, the drug is also being tested as a possible functional cure for chronic hepatitis B. In the Phase II multi-center trial, participants will receive 1 mg/kg or 2.5 mg/kg or a placebo plus ART therapy once a month over a 12-week treatment phase and then a 12-week follow-up period. Subjects will receive the drug via subcutaneous injection. In the placebo group, ASC22 will be replaced by 0.9% saline. Primary outcome measures are changes in CD4 and CD8 ratios from baseline at weeks four, eight and 12. ART therapy has proven to be effective in delaying disease progression and suppressing HIV replication. However, it is not curative. ART cannot remove the HIV reservoir, and all infected individuals experience viral rebounds within weeks or a few months after the therapy is stopped. ASC22 is designed to boost the immune system against HIV-1 to enhance the body's ability to clear the reservoir. "This study is conducive to further exploring the possibility of clearing [the] HIV reservoir to achieve the functional cure of HIV/AIDS. We expect to generate more evidence to support this immune-based strategy and benefit more people," Professor Fu-Sheng Wang, M.D., Ph.D., principal investigator of the Phase II trial and director of the department of infectious diseases at Fifth Medical Center of the Chinese PLA General Hospital, said. World Health Organization 2020 data logs 37.7 million people living with HIV worldwide, and in the same year, the disease saw 1.5 million new cases and 680,000 deaths. The African region remains most hit by the virus, with one in every 25 adults (ages 15 and up) living with HIV, which translates to around two-thirds of the global case numbers. ART remains the therapy of choice, but only approximately 73% have access to it. The Phase II trial of ASC22 "marks a new milestone that Ascletis has achieved in developing therapy for (a) functional cure of HIV/AIDS, which is still a challenge in China and globally despite the improved access of standard ART treatment," Dr. Jinzi J. Wu, founder, chairman and chief executive officer of Ascletis commented. "By blocking [the] PD-1/PD-L1 pathway, ASC22 is expected to potentially restore HIV-1 specific immunity and clear the latent HIV reservoir." Ascletis joins the roster of biotech companies looking to finally cure HIV infection. In February, ImmunityBio announced promising results from the clinical study of its IL-15 superagonist Anktiva for those living with HIV. In March, Moderna dosed the first participant in a Phase I trial for a possible HIV trimer mRNA vaccine. In the same month, the U.S. Food and Drug Administration rejected Gilead Sciences' attempt at a New Drug Application for lenacapavir, which is being proposed for the treatment of HIV-1. There remains no cure for HIV as of this writing.