PlasmaCap IG (human immune globulin IV 10%) / National Resilience - LARVOL DELTA

Potential predictive value of phylogenetic novelties in clinical fungi, illustrated by Histoplasma. (PubMed, IMA Fungus) - "The phylogeny of the vertebrate pathogen Histoplasmacapsulatum and its varieties was analyzed on the basis of GenBank data, comparing preceding papers that distinguished lineages on the basis of a much smaller dataset, partly dating back two decades...farciminosum, although strains analyzed thus far are indistinguishable from South American strains. On the basis of phylogenetic data, Indian and Indonesian clades are separate, but more clinical data are needed to establish their value as individual species."

Journal

PlasmaCap EBA: An innovative method of isolating plasma proteins from human plasma. (PubMed, Vox Sang) - "The PlasmaCap EBA platform was used to successfully develop PlasmaCap IG (10% liquid formulation IVIG) with proven scalability, product quality and yield."

Journal

"Evolve Biologics® Confirms Selection of DPR Construction as General Contractor for First Manufacturing Facility in Texas, Demonstrating Further Progress Toward Commercialization of Its Innovative PlasmaCap EBA® Technology https://t.co/euSKkHHnSs" (@NewsFromBW)

[VIRTUAL] Efficacy and Safety of PlasmaCap IG, A New 10% Intravenous Immunoglobulin Manufactured Using an Innovative Chromatography Process, in Adults and Children with Primary Immunodeficiency Disorders (CIS 2021) - "No subject experienced a treatment-related serious adverse event (SAE), hemolysis, thromboembolism, or renal failure. This study demonstrated that PlasmaCap IG is safe and effective in the treatment of adult and pediatric patients with PIDD."

Clinical • Cardiovascular • Fatigue • Hematological Disorders • Immunology • Infectious Disease • Pain • Pediatrics • Primary Immunodeficiency • Renal Disease

"FastCheck PPR-like"-A Molecular Tool for the Fast Genome Detection of PPRV and Differential Diagnostic Pathogens. (PubMed, Viruses) - "Furthermore, a high-speed multi-well RT-qPCR for the genome detection of PPRV and additional important pathogens such as Foot-and-mouth disease virus, Parapoxvirus ovis, Goatpox virus, and Mycoplasmacapricolumsubsp.capripneumoniae was established and combined with suitable internal control assays...The final evaluation was conducted on the BioRad CFX96 and also on a portable Liberty16 qPCR cycler. The new molecular test designated as "FastCheck PPR-like", which is based on rapid nucleic acid extraction and high-speed RT-qPCR, delivered reliable results in less than one hour, allowing its use also in a pen-side scenario."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases

Study of PlasmaCap IG in Adults and Children With PIDD (clinicaltrials.gov) - P3; N=74; Active, not recruiting; Sponsor: Therapure Biopharma Inc; Recruiting ➔ Active, not recruiting; Trial completion date: May 2020 ➔ Dec 2020; Trial primary completion date: Feb 2020 ➔ Aug 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

Cysteine Dioxygenase Enzyme Activity and Gene Expression in the Dimorphic Pathogenic Fungus Histoplasma capsulatum Is in both the Mold and Yeast Morphotypes and Exhibits Substantial Strain Variation. (PubMed, J Fungi (Basel)) - "In the dimorphism (mold/yeast) Histoplasmacapsulatum (Hc) literature are reports that yeast (the so-called pathogenic form) uniquely expresses a cysteine dioxygenase (CDO, approx...Furthermore, we show via a FLAG-tag analysis that the expressed protein is approximately 24.7 ± 2.4 kd, in agreement with the putative protein sequence (determined from cDNA sequence) which yields 23.8 kd and is consistent with most other eukaryotic CDO enzymes. Additionally, we demonstrate that intracellular cysteine levels are actually significantly higher in the mold form of the two Panamanian strains, 184AS and 186AS, equal in both mold and yeast in the class 1 Downs strain and significantly higher in yeast of the more pathogenic class 2 G217B strain."

Journal

Study of PlasmaCap IG in Adults and Children With PIDD (clinicaltrials.gov) - P3; N=74; Recruiting; Sponsor: Therapure Biopharma Inc; Trial completion date: Jan 2020 ➔ May 2020; Trial primary completion date: Dec 2018 ➔ Feb 2020

Clinical • Trial completion date • Trial primary completion date

INTERIM SAFETY DATA IN A PROSPECTIVE, OPEN-LABEL, MULTI-CENTER STUDY OF THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PLASMACAP IG IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES (PIDD) (AAAAI 2019) - "In the ongoing clinical study, these interim data appear to indicate that PlasmaCap IG is a safe and well tolerated treatment for patients with PIDD. The low rate of adverse reactions may be associated with our unique manufacturing process that minimizes aggregates and other contaminants."

Clinical • PK/PD data