FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis

Cryptococcal Meningitis Included in FDA Tropical Disease Priority Review Voucher Program SAN DIEGO, Feb. 11, 2019 -- (Healthcare Sales &Marketing Network) -- Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening inf... Biopharmaceuticals, FDA Amplyx Pharmaceuticals, APX001, cryptococcosis
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news

Related Links:

Conclusions and significanceFluconazole MIC50 and MIC90 values were two-fold higher in 2017 compared to 2007 –2008. Although there are no breakpoints, higher fluconazole doses may be required to maintain efficacy of standard treatment regimens for cryptococcal meningitis.
Source: PLoS Neglected Tropical Diseases - Category: Tropical Medicine Authors: Source Type: research
Early cryptococcal disease can be detected via circulating antigen in blood before fulminant meningitis develops, when early antifungal therapy improves survival. Two semiquantitative cryptococcal antigen (CrAg) lateral flow assays (LFAs) have been developed, but their diagnostic performance has not been defined. Cryopreserved serum samples from HIV-infected Ugandans obtained as part of a prospective CrAg-screening cohort were tested in duplicate for CrAg by the CrAgSQ (IMMY) and CryptoPS (Biosynex) lateral flow assays. Case-controlled diagnostic performance was measured using the FDA-approved CrAg LFA (IMMY) as a referenc...
Source: Journal of Clinical Microbiology - Category: Microbiology Authors: Tags: Mycology Source Type: research
Publication date: Available online 22 February 2020Source: Multiple Sclerosis and Related DisordersAuthor(s): Mohammad Hossein Harirchian, Maryam Poursadeghfard, Alireza Sadeghipour, Hoda Kamali, Payam SarrafAbstractFingolimod has been the first approved oral medication in MS for its relapsing remitting type. It is a non-selective sphingosine1-phosphate (S1P) receptor modulator on lymphocytes. Engagement of this receptor blocks the T cells and B cells migration from the lymph nodes into the inflamed central nervous system (CNS) via bloodstream. In spite of this known immunomodulatory mechanism, there are some reports about...
Source: Multiple Sclerosis and Related Disorders - Category: Neurology Source Type: research
Activated B cells modulate infection by differentiating into pathogen-specific antibody-producing effector plasmablasts/plasma cells, memory cells, and immune regulatory B cells. In this context, the B cell phenotypes that infiltrate the central nervous system during human immunodeficiency virus (HIV) and cryptococcal meningitis coinfection are ill defined. We characterized clinical parameters, mortality, and B cell phenotypes in blood and cerebrospinal fluid (CSF) by flow cytometry in HIV-infected adults with cryptococcal (n = 31) and noncryptococcal (n = 12) meningitis and in heathy control subjects with neither infectio...
Source: Infection and Immunity - Category: Infectious Diseases Authors: Tags: Host Response and Inflammation Source Type: research
Abstract Cryptococcosis has become an important infection in both immunocompromised and immunocompetent hosts. Although Cryptococcus is mainly recognized by its ability to cause meningoencephalitis, it can infect almost any organ of the human body, with pulmonary infection being the second most common disease manifestation. In cases of meningitis, symptom onset may be insidious, but headaches, fevers, or mental status changes should warrant diagnostic testing. Symptoms of pulmonary disease are nonspecific and may include fever, chills, cough, malaise, night sweats, dyspnea, weight loss, and hemoptysis. Due to prot...
Source: Respiratory Care - Category: Respiratory Medicine Authors: Tags: Semin Respir Crit Care Med Source Type: research
Semin Respir Crit Care Med 2020; 41: 069-079 DOI: 10.1055/s-0039-3400280Cryptococcosis has become an important infection in both immunocompromised and immunocompetent hosts. Although Cryptococcus is mainly recognized by its ability to cause meningoencephalitis, it can infect almost any organ of the human body, with pulmonary infection being the second most common disease manifestation. In cases of meningitis, symptom onset may be insidious, but headaches, fevers, or mental status changes should warrant diagnostic testing. Symptoms of pulmonary disease are nonspecific and may include fever, chills, cough, malaise, night swe...
Source: Seminars in Respiratory and Critical Care Medicine - Category: Respiratory Medicine Authors: Tags: Review Article Source Type: research
AbstractPurpose of reviewTo describe the host-pathogen factors that impact the management of cryptococcal meningitis (CM) in immunosuppressed patients that lead to the development of cryptococcal immune reconstitution inflammatory syndrome (C-IRIS).Recent findingsThe pre-screening of HIV-infected patients in resource-poor countries with the lateral flow cryptococcal antigen assay could prevent C-IRIS. Delaying ART by 4  weeks is associated with improved survival and recommended by guidelines; this approach remains controversial in wealthier areas as there is limited data. A 5-flucytosine-based combination regimen and ...
Source: Current Treatment Options in Infectious Diseases - Category: Infectious Diseases Source Type: research
AbstractPurpose of ReviewCryptococcal meningitis is one of the most seriously opportunistic infections in people living with HIV. We evaluated clinical and laboratorial features (minimum inhibitory concentrations for fluconazole, initial fungal burden in cerebrospinal fluid) and risk factors associated with in-hospital mortality.Recent FindingsThere is no good evidence for the use of minimum inhibitory concentrations for fluconazole in routine practice for the management of cryptococcosis patients. Counting yeast cells at cerebrospinal fluid can predict positive culture by not death.SummaryData from 46 cryptococcal meningi...
Source: Current Fungal Infection Reports - Category: Infectious Diseases Source Type: research
We describe here a young immuncompetent adult of Indian origin from Ghana, West Africa with cryptococcal meningitis who had several ups and downs during his treatment. First he developed neurologic worsening due to premature transition from intensive to consolidation phase therapy. Subsequently he deteriorated due to “immune reconstitution inflammatory syndrome (IRIS)” like phenomenon that necessitated the prolonged use of steroids. Additionally he suffered serious adverse effects due to antifungal drugs including liposomal amphotericin B and flucytosine. He recovered after 16 months of treatment. The case high...
Source: Medical Mycology Case Reports - Category: Biology Source Type: research
Publication date: Available online 6 December 2019Source: Wilderness &Environmental MedicineAuthor(s): James H. DiazCryptococcus neoformans, a soil-dwelling fungus found worldwide, can cause cryptococcosis, an opportunistic fungal infection of the lungs and central nervous system. One former member of the C neoformans complex, Cryptococcus gattii, has caused meningitis in immunosuppressed and immunocompetent persons in endemic regions in Africa and Asia. Between 1999 and 2004, C gattii caused outbreaks of human cryptococcosis in unexpected, nonendemic, nontropical regions on Vancouver Island, Canada, and throughout the...
Source: Wilderness and Environmental Medicine - Category: Environmental Health Source Type: research
More News: Cryptococcosis | Grants | Marketing | Men | Meningitis | Pharmaceuticals