The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in January 2018.
Parenteral Norovirus Vaccine Formulations; C. Richardson and T.R. Foubert; Takeda Vaccines, Inc. US; U.S. Patent # 9,867,876; January 16, 2018.
Noroviruses are non-cultivatable human Caliciviruses that have emerged as the single most important cause of epidemic outbreaks of non-bacterial gastroenteritis. The present invention relates to single dose parenteral vaccine compositions comprising mixtures of monovalent Norovirus virus-like particles. The single dose vaccine compositions can comprise doses of about 5 µg to about 150 µg of genogroup I Norovirus VLPs (virus-like particles), genogroup II Norovirus VLPs, or both. The inventors used GI.1 as a genogroup I Norovirus VLP and GII.4 as the genogroup II Norovirus VLP. The composition can be administered by various routes, preferably intramuscularly.
Granulysin in Immunotherapy; A.M. Krensky and C. Clayberger; Th e United States of America, as represented by described here the Secretary, Department of Health and Human Services, US; U.S. Patent # 9,855,330; January 2, 2018.
Granulysin is a substance released by cytotoxic T cells (CD8) and natural killer cells (NK cell) when they are attached to infected body cells. It functions to create holes in the target cell membrane and destroy it. This patent relates to methods for the treatment of immunebased disorders, such as autoimmune diseases, organ transplantation rejection, tumor immunotherapy and the stimulation of an immune response in a host upon administration of a therapeutically effective amount of 15 kD granulysin. It provides a method for enhancing the efficacy of a vaccine, without simultaneously initiating a cytolytic response in a host. 15 kD granulysin activates monocytes to differentiate into monocyte derived-dendritic cells (MO-DC), thereby initiating an immune response in a subject that can produce allospecific T cells, and can therefore be used as a vaccine adjuvant, alone or in combination with other vaccine preparations or therapeutic agents.
Topical Composition Comprising Transformed Bacteria Expressing a Compound of Interest; TopGeniX, Inc., US; N. Qvit-Raz and T. Altman; U.S. Patent # 9,868,957, January 16, 2018.
The present invention describes a topical composition comprising transformed bacteria, which are created from a non-pathogenic bacteria and transformed to express a compound of interest for a therapeutic or a cosmetic purpose. The composition is for protection of the skin from ultraviolet rays. The patent claims a composition, comprising a population of non-pathogenic bacteria obtained from a nonpathogenic human skin microbiome genetically transformed to express a mycosporine-like amino acid (MAA) at a level of 0.1 mM to 100 mM for 102-1020 cfu of the genetically transformed bacteria, the composition formulated for topical application to a subject.
Lipid Formulations for Delivery of Th erapeutic Agents to Solid Tumors; E. Yaworski, S. Reid, J. Heyes, A. Judge, and I. MacLachlan; Protiva Biotherapeutics, Inc., US; U. S. Patent # 9,878,042; January 30, 2018.
There is a strong need for novel compositions and methods for preferentially introducing nucleic acids such as interfering RNA into tumor cells. In addition, there is a need for methods of down-regulating the expression of genes associated with cell transformation to treat or prevent cancer. The patent addresses the same issue and claims a novel, serum-stable lipid particles comprising of therapeutic agents and methods of making and delivering the lipid particles. The nucleic acid-lipid particle comprises of: a nucleic acid; a cationic lipid comprising from 50 - 60 mol % of the total lipid present in the particle; a non-cationic lipid comprising from 35 - 45 mol % of the total lipid present in the particle and a polyethylene glycol (PEG)-lipid conjugate with average molecular weight of from 550 Da to 1000 Da, that inhibits aggregation of particles. The nucleic acid comprises of an interfering siRNA, which has double-stranded region of about 19 to about 25 nucleotides in length.
Polymersome Encapsulation of Hydrophobic Fluorescent Polymers; M. Mehrpouyan, S. Mamo and M. Sharkey; Becton, Dickinson and Company, US; U.S. patent # 9,863,947; January 9, 2018.
Polymersomes are prepared using amphiphilic di-block copolymers comprising a hydrophobic block and a hydrophilic block. The hydrophobic block forms a hydrophobic core structure and the hydrophilic block is oriented on the surface of polymersomes, which in turn faces the aqueous phase outside. In this patent, hydrophobic fluorescent polymers are incorporated in the core. The signals generated by fluorescent polymers can be used to detect biological targets and events. In some embodiments, the inventors made polymersomes with tri-block (two hydrophobic+one hydrophilic) or tetra-block (one hydrophobic+three hydrophilic or 2 hydrophobic+2 hydrophilic) copolymers.
Method and System for Real-Time Vibroacoustic Condition Monitoring and Fault Diagnostics in Solid Dosage Compaction Presses; C. Cetinkaya; Clarkson University, US; U.S. Patent # 9,863,917; January 9, 2018.
This patent relates to methods and systems for condition monitoring of fault diagnostics in solid dosage compaction presses. It also provides methods and systems for real-time vibroacoustic condition monitoring of fault diagnostics in solid dosage compaction presses. Physical properties and mechanical integrity of drug tablets often affect their therapeutic functions. This invention presents non-contact/non-destructive techniques for determining the mechanical properties of coated tablets. It highlights a method of detecting, monitoring and characterizing a drug tablet during compaction which includes: forming a tablet from a powder core in a compactor, transmitting acoustic waves into the powder core while the tablet is being formed, receiving acoustic waves from the powder core while the tablet is being formed, measuring data received from the received acoustic waves; calculating the data, and presenting the data.
Drug Delivery Regulator; C. Blackburn; Zolo Solutions, Inc., US; U.S. patent # 9,870,450; January 16, 2018.
There is a need for an apparatus, and a method for securely dispensing medications and other controlled substances according to a prescribed schedule and dosage. The patent claims a portable, hand-held, sterilizable container, which is tamper-resistant and can withstand severe physical manipulation. It consists of one access compartment, one regulating unit, one variable insert that controls the amount of contents being dispensed and a locking mechanism, which is operated by a controller. There is a communication component, which is governed by the controller and it is configured to enable wireless communication. The access compartment contains a drug having a dosage form consisting of: a pill, a tablet, a capsule, a solution, a suspension, an emulsion, an aerosol, an elixir, a patch, a cream, a lotion, and ointment, a gel, an inhalant, a lozenge, a wafer, and combinations thereof.