Clinical Trials on COVID-19: What is Being Researched in the United States?

The emergence of Coronavirus Disease 2019 (COVID-19) in late 2019 has brought great challenges to public health worldwide and, to date, there is no specific approved therapeutic protocol. Therefore, this chapter will analyze types of intervention for use in patients with COVID-19 developed by American researchers from records made on the Clinical Trials platform. For the search strategy, keywords “COVID-19” in the “Condition or Disease” section and “United States” in the “Country” section were used. No filters were applied. Data were descriptively analyzed. In total, 1,182 studies were obtained, of which 496 met the eligibility criteria. Sample size ranged from 1 to 10,000 participants. Most studies involved the age group of 18–64 years (48.6%). As for design, randomized type (80.5%), parallel (75.6%), open designs (38.7%) and those with therapeutic purpose (88.3%) were more frequent. Most clinical trials used the two-arm trial (67.3%), researched drugs (64.8%), used placebo (55.2%) and were sponsored by pharmaceutical/biotechnology companies (35.4%). Clinical trials developed by American researchers on COVID-19 involve adult and elderly participants, with predominance of randomized, parallel and open design, for therapeutic purposes and mostly evaluated immunosuppressants or combinations of antivirals/immunosuppressants. The drugs and biological products Remdesivir, Baricitinib in combination with Remdesivir, Bamlanivimab and Etesevimab, REGEN-COV and COVID-19 convalescent plasma were also used, authorized for emergency use.

Protein Therapeutics: An Updated Review

Therapeutic protein are one of the prime option of biologicals as per their clinical uses. In recent times, uses of therapeutic protein increases day by day. Protein therapeutics are used extensively to treat various diseases like cancer, AIDS etc. Due to recent advancement in pharmaceutical biotechnology the interest towards therapeutic proteins are augmenting nowadays. Various clinical research are going on in this field to treat different diseases and pharmaceutical industries are also make interest on therapeutic proteins. Among the various treatment options therapeutic protein will provide highest chance of clinical success. Some recent clinical trials demonstrate that therapeutic protein may provide the safe and potential option to treat various diseases, but there are some drawbacks also like some immunogenic issues, safety, stability problem of protein, degradation of protein in various conditions.

Cell-Penetrating Peptides Derived from Animal Venoms and Toxins

Cell-penetrating peptides (CPPs) comprise a class of short polypeptides that possess the ability to selectively interact with the cytoplasmic membrane of certain cell types, translocate across plasma membranes and accumulate in the cell cytoplasm, organelles (e.g., the nucleus and mitochondria) and other subcellular compartments. CPPs are either of natural origin or de novo designed and synthesized from segments and patches of larger proteins or designed by algorithms. With such intrinsic properties, along with membrane permeation, translocation and cellular uptake properties, CPPs can intracellularly convey diverse substances and nanomaterials, such as hydrophilic organic compounds and drugs, macromolecules (nucleic acids and proteins), nanoparticles (nanocrystals and polyplexes), metals and radionuclides, which can be covalently attached via CPP N- and C-terminals or through preparation of CPP complexes. A cumulative number of studies on animal toxins, primarily isolated from the venom of arthropods and snakes, have revealed the cell-penetrating activities of venom peptides and toxins, which can be harnessed for application in biomedicine and pharmaceutical biotechnology. In this review, I aimed to collate examples of peptides from animal venoms and toxic secretions that possess the ability to penetrate diverse types of cells. These venom CPPs have been chemically or structurally modified to enhance cell selectivity, bioavailability and a range of target applications. Herein, examples are listed and discussed, including cysteine-stabilized and linear, α-helical peptides, with cationic and amphipathic character, from the venom of insects (e.g., melittin, anoplin, mastoparans), arachnids (latarcin, lycosin, chlorotoxin, maurocalcine/imperatoxin homologs and wasabi receptor toxin), fish (pardaxins), amphibian (bombesin) and snakes (crotamine and cathelicidins).

PROSPECTS AND CHALLENGES OF PHARMACEUTICAL BIOTECHNOLOGY

Biotechnology is a broad area of biology, involving the use of living systems and organisms to develop products. Depending on the tools and applications, it often overlaps with related scientific fields. In the late 20th and early 21st centuries, biotechnology has expanded to include new and diverse sciences, such as genomics, recombinant gene techniques, applied immunology, and development of pharmaceutical therapies and diagnostic tests. Biotechnology has also led to the development of antibiotics. Biotechnology has applications in four major industrial areas, including health care (medical), crop production and agriculture, non-food (industrial) uses of crops and other products and environmental uses. In medicine, modern biotechnology has many applications in areas such as pharmaceutical drug discoveries and production, pharmacogenomics, and genetic testing. Pharmaceutical biotechnology is a relatively new and growing field in which the principles of biotechnology are applied to the development of drugs. A majority of therapeutic drugs in the current market are bio formulations, such as antibodies, nucleic acid products and vaccines. Such bio formulations are developed through several stages that include: understanding the principles underlying health and disease the fundamental molecular mechanisms governing the function of related biomolecules synthesis and purification of the molecules determining the product shelf life, stability, toxicity and immunogenicity drug delivery systems patenting and clinical trials. This review article describes the purpose of biotechnology in pharmaceutical industry, particularly pharmaceutical biotechnology along with its prospects and challenges.