By a Account Reporter-Staff Account Editor at Pharma Business Week — According to account advertisement basic from Alexandria, Virginia, by NewsRx journalists, a apparent by the inventors Moriarty, Robert M. (Michiana Shores, IN); David, Nathaniel E. (Los Angeles, CA); Mahmood, Nadir Ahmeduddin (Calabasas, CA), filed on September 30, 2014, was appear online on December 20, 2016 (see additionally Biologic Companies).
The abettor for this patent, apparent cardinal 9522155, is KYTHERA BIOPHARMACEUTICALS, INC. (Calabasas, CA).
Reporters acquired the afterward adduce from the accomplishments advice supplied by the inventors: “Cholanology, the abstraction of acerbity acids, and decidedly acerbity acerbic allure has been of assimilation for the bigger allotment of a century. Although abundant is known, acerbity acerbic allure involves a advanced array of actinic entities, abounding with hasty properties. For a review, see, e.g., Mukhopadhyay, S. and U. Maitra., Current Science 87: 1666-1683 (2004) (‘Chemistry and analysis of acerbity acids’), congenital herein by reference.
“Bile acids are characterized by two abutting units, a adamant steroid basis and a abbreviate aliphatic ancillary alternation (see FIG. 1 of the present application). See, Hofmann, A. F., et al. For a proposed classification for acerbity acids, see J. Lipid Res. 33:599-604 (1992). Both the basis and the ancillary alternation accept a ample cardinal of accessible steric arrangements. The basis can be adapted by amplification or abbreviating of alone rings, and the ancillary alternation can be beneath or lengthened. In addition, both genitalia of the acerbity acerbic atom accept a ample cardinal of accessible arctic substituents. Ionizing groups may be present on the basis or the ancillary chain. Finally, conjugating groups may be present on the basis (e.g., sulfate, glucuronate, phosphate) or on the ancillary alternation (glycine or taurine or added amino acids, or alike sugars). The ancillary alternation anatomy determines the chic of the admixture (bile acids or acerbity salts).
“Bile acids are amphiphiles, accepting both an amphiphilic and amphipathic ‘face’.
“By convention, the berserk apparent is alleged the ‘.beta.-face’ and the hydrophilic apparent is alleged the ‘.alpha.-face’. The .beta.-face is lipid acrid and the .alpha.-face is almost polar, in general. There are acerbity acids, such as those accepting arctic groups (hydroxyl groups, in artlessly occurring acerbity acids) on the berserk face as able-bodied as on the hydrophilic face, e.g., ursodeoxycholic acid. The amphipathic attributes of the atom is amenable for its basic alloyed micelles with amphipathic but water-insoluble lipids, such as phosphatidylcholine. Acerbity acids will not solubilize comestible lipids in the anatomy of alloyed micelles unless acerbity acids are aloft a analytical concentration, termed the analytical micellization concentration.
“The acerbity acids begin in greatest admeasurement in bodies are chenodeoxycholic acerbic and deoxycholic acid. Deoxycholic acerbic is additionally accustomed as deoxycholate, cholanoic acid, and 3.alpha.,12.alpha.-dihydroxy-5.beta.-cholanate. In the beastly anatomy deoxycholic acerbic is acclimated in the emulsification of fats for the assimilation in the intestine. In research, deoxycholic acerbic is acclimated as a balmy bactericide for the abreast of film associated proteins. Back essentially pure, deoxycholic acerbic is a white to fair apparent crumb form. Deoxycholic acerbic is one of the four capital acids produced by the liver. It is acrid in booze and acerb acid. The CAS cardinal for deoxycholic acerbic is [83-44-3].
“Rapid abatement of anatomy fat is an age-old ideal, and abounding substances accept been claimed to achieve such results, although few accept apparent results. ‘Mesotherapy’, or the use of injectables for the abatement of fat, is not broadly accustomed amid medical practitioners due to assurance and adeptness concerns, although homeopathic and corrective claims accept been fabricated back the 1950’s. Mesotherapy was originally conceived in Europe as a adjustment of utilizing cutaneous injections absolute a admixture of compounds for the analysis of bounded medical and corrective conditions. Although mesotherapy was commonly alive for affliction relief, its corrective applications, decidedly fat and blubber removal, accept afresh accustomed absorption in the United States. One such appear analysis for localized fat reduction, which was affected in Brazil and uses injections of phosphatidylcholine, has been afield advised alike with mesotherapy. Despite its allure as a declared ‘fat-dissolving’ injection, the assurance and adeptness of these corrective treatments abide cryptic to best patients and physicians. See, Rotunda, A. M. and M. Kolodney, Dermatologic Anaplasty 32:, 465-480 (2006) (‘Mesotherapy and Phosphatidylcholine Injections: Historical Clarification and Review’).
“WO 2006/133160 (incorporated herein by advertence in its absoluteness including figures) describes methods for lipomodeling, e.g., abridgement of a fat depot, by administering a neuropeptide Y receptor adversary to the armpit of the fat depot. Kolonin M. G. et al., Nat. Med. June 10(6):625-32 (2004), describes fat careful pro-apoptotic peptides accepting almighty fat corpuscle killing effects. The declared pro-apoptotic peptides crave admission to the vasculature to kill.
“Recently appear abstract letters that deoxycholic acerbic has fat removing backdrop back injected into blubbery deposits in vivo. See, WO 2005/117900 and WO 2005/112942, as able-bodied as US2005/0261258; US2005/0267080; US2006/127468; and US20060154906, all congenital herein by advertence in their absoluteness including figures). Deoxycholate injected into fat tissue has two effects: 1) it kills fat beef via a cytolytic mechanism; and 2) it causes bark tightening. Both of these furnishings are appropriate to arbitrate the adapted artful corrections (i.e., anatomy contouring). Because deoxycholate injected into fat is rapidly inactivated by acknowledgment to protein and afresh rapidly allotment to the abdominal contents, its furnishings are spatially contained. As a aftereffect of this abrasion aftereffect that confers analytic safety, fat abatement therapies about crave 4-6 sessions. This localized fat abatement afterwards the charge for anaplasty is benign not alone for ameliorative analysis apropos to dissection localized fat deposits (e.g., dyslipidemias adventure to medical action in the analysis of HIV), but additionally for corrective fat abatement afterwards the accessory accident inherent in anaplasty (e.g., liposuction). See, Rotunda et al., Dermatol. Anaplasty 30: 1001-1008 (2004) (‘Detergent furnishings of sodium deoxycholate are a above affection of an injectable phosphatidylcholine conception acclimated for localized fat dissolution’) and Rotunda et al., J. Am. Acad. Dermatol. (2005: 973-978) (‘Lipomas advised with subcutaneous deoxycholate injections’), both congenital herein by reference.
“Pharmaceutical brand acerbity acerbic affairs are commercially accessible at almost low cost. This low amount is due to the actuality that the acerbity acids are acquired from beastly carcasses, decidedly ample animals such as beasts and sheep. Importantly, as with all medicaments from beastly sources, there is affair that the animal-derived acerbity acerbic articles may accommodate beastly bacilli and added adverse agents such as beastly or microbial metabolites and toxins, including bacterial toxins such as pyrogens.
“Such beastly bacilli can accommodate prions, which are anticipation to be a blazon of communicable pathogenic protein that may account prion diseases. Prion diseases are degenerative disorders of the afraid system. One such disease, ‘Mad cow’ ache (thought to be a addition of Creutzfeldt-Jakob ache (CJD)), is anticipation to be acquired by a prion present in comestible beef from afflicted cows. Best cases are desultory with alien approach of transmission; some cases are inherited; and a baby cardinal accept been transmitted by medical procedures. The beforehand of beastly prion diseases through burning of adulterated actual has been alive historically in kuru and afresh in addition CJD. Added beastly prion diseases (scrapie of sheep, catching cape encephalopathy, abiding crumbling ache of cervids, and bovine spongiform encephalopathy) all assume to be alongside transmitted by acquaintance with adulterated animals or by burning of adulterated feed. Accident appraisal and predictions of approaching contest pertaining to prion diseases are difficult to ascertain because of the altered modes of transmission, the capricious breed barriers, the capricious administration of infectivity in tissues, and ache variations begin in some diseases.
“In general, beastly articles may be apparent to microbial bacilli which aftermath pyrogens (fever-causing substances). Bacterial contaminants of aliment and/or biologic articles are additionally a austere affair as apparent by contagion of aliment stuffs by enterohemoragic E. coli. Articles such as meats acquired from beasts as able-bodied as aftermath such as apples, spinach, and the like, accept been alive in such contamination. In such cases, it is the adulteration produced by the bacilli (rather than the bacilli itself) that produces adverse furnishings in humans. Such adverse furnishings accommodate astringent diarrhea, branch abortion and in the acute situations, death. Bacterial endotoxins, a blazon of pyrogen, charge be essentially afar from all biologic compositions.
“Animal articles are about antiseptic by a action of elimination, i.e., rather than selecting the end-product from a mix, the end artefact is the actual actual afterwards exclusion of impurities. And, in accession to the abeyant beastly moieties such as pathogens, accession antiquity of ablution from beastly sources is that the end-product is a admixture of one or added acerbity acids. For example, bartering affairs of deoxycholic acerbic accommodate some chenodoxycholic acid, as able-bodied as cholic acid, which is a forerunner to both deoxycholic acerbic and chenodeoxycholic acerbic in beastly acerbity acerbic synthesis. Because the exact admeasurement of deoxy/cheno/cholic is not preselected, this may aftereffect in lot-to-lot aberration back advertent accomplishment ample amounts of acerbity acids. Such lot-to-lot aberration can be ambiguous and may arouse added accomplish in accumulation authoritative approvals or affection control, decidedly in efforts to aftermath a biologic composition. Clearly, producers would admiration lot-to-lot adequation in accomplishment acerbity acerbic biologic compositions.
“Currently, the apropos apropos animal-derived articles absolute beastly bacilli and added adverse agents has been addressed by sourcing from abandoned and inspected animals. For example, deoxycholic acerbic from animals in New Zealand are a antecedent of acerbity acids for beastly use beneath US authoritative regimes, as continued as the animals abide to abide abandoned and contrarily chargeless of appreciable pathogens.
“Implicitly, by the charge for such governmentally controlled authoritative administration is the acceptance of an built-in accident of manual of beastly bacilli back animal-derived medicaments are injected. Breadth azoic medicament alternatives become available, the authoritative authoritative administration is no best needed. An archetype of such addition (non-animal medicament replacing animal-derived medicament) and associated advantages is insulin for beastly use. The accomplish of beef insulin in the United States was discontinued in 1998, and pork insulin for beastly use was discontinued in January of 2006. Although beastly insulin can be acquired from herds not accustomed to accept had acknowledgment to BSE-causing or added pathogenic agents, the accomplishment accessories or processes can betrayal the beastly capacity to animals which accept had acknowledgment to the pathogens. The accident of manual of pathogenic agents to bodies can be alone with the use of insulin that is bogus recombinantly or synthetically. For consumers, the insulin bearings is instructive: breadth constructed actual is advisedly available, the accident of manual of beastly bacilli is in approach eliminated. For producers, the adeptness to aftermath a authentic actinic commodity that is essentially chargeless of actual of beastly bacilli is advantageous for safety, quality, and authoritative purposes. Further, a constructed action about provides for a added reproducible artefact than that acquired from biological sources.
“Presently, because of the about affluence of beastly carcass-derived acerbity acids, the industry has not taken accomplish to either absolutely chemically amalgamate acerbity acids, or adapt acerbity acids application phytosterol or microbial starting materials. And although acerbity acerbic derivatives accept been synthesized, this assignment afresh primarily complex animal-derived acerbity acids as starting abstracts for steroid chemistry, due to the low amount and accessible availability of beastly materials. Despite historically alive efforts in phytosterol research, there are no readily-commercially accessible phytosterol-derived acerbity acerbic biologic brand compositions. See, e.g., Mukhopadhyay, S. and U. Maitra., Current Science 87: 1666-1683, 1670 (2004) (Noting that the absolute amalgam of any acerbity acerbic had not been performed accountable to a 1981 reference, Kametani et al. J. Am. Chem. Soc. 103: 2890 (1981)(‘First Absolute Amalgam of ( )-Chenodeoxycholic Acid’). Microbial, such as bacterially-produced acerbity acids, accept been acclimated in situ as bacterial products, e.g., for abyssal oil discharge clean-up. See, Maneerat et al., Appl. Microbiol. Biotechnol. 76: 679-683 (2004) (‘Bile acids are new articles of a mariene bacterium, Myroides sp. Ache SM1’).
“In adjustment to apprehend the abounding abeyant of deoxycholic acerbic for the abatement of fat, it is acute that the apropos over the use of beastly acquired articles be added addressed. Clearly, there is a charge for acceptable quantities of active acerbity acids and accompanying compositions, such as the deoxycholic acids, that are accustomed from the alpha to be chargeless from moieties of beastly agent (or pathogenic moieties able of acting in an animal, decidedly a mammal, and for beastly use, accepting a deleterious aftereffect on a human), and added adverse agents such as beastly or microbial metabolites, toxins, including bacterial toxins, such as pyrogens, for use as medicaments in humans. The present apparatus addresses this affair by accouterment synthetically able acerbity acerbic compositions chargeless of the abeyant accident of beastly bacilli and added adverse agents. The appear acerbity acerbic compositions can be acclimated in adipolytic analysis and will serve to added beforehand analysis and adorning efforts in the breadth of localized fat removal.”
In accession to accepting accomplishments advice on this patent, NewsRx editors additionally acquired the inventors’ arbitrary advice for this patent: “Adequate quantities of acceptable acerbity acerbic as a authentic biologic agreement is herein provided, as able-bodied as methods for amalgam thereof. Acerbity acerbic compositions and methods so provided are not abandoned from beastly or microbial bacilli that artlessly aftermath the acerbity acids. In one aspect, accurate deoxycholic acerbic biologic compositions which are chargeless of all moieties of beastly agent and of beastly and/or bacterial pyrogens, and accompanying methods for assembly and use are provided. In accession aspect, able quantities of acceptable deoxycholic acids as authentic biologic compositions are provided which can be acclimated as an injectable biologic agreement for localized fat removal, forth with accompanying compositions, methods for accomplish and methods of use. The authentic deoxycholate injectates of the present apparatus may be accumulated with a atom that causes fat to die by an erect mechanism, e.g., NPY antagonists and/or fat careful pro-apoptotic peptides, to accommodate agents to be acclimated to actualize a added almighty agency to arbitrate anatomy contouring in beneath ameliorative sessions.”
For added information, see this patent: Moriarty, Robert M.; David, Nathaniel E.; Mahmood, Nadir Ahmeduddin. Constructed Acerbity Acerbic Compositions and Methods. U.S. Apparent Cardinal 9522155, filed September 30, 2014, and appear online on December 20, 2016. Apparent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/PTO/srchnum.htm&r=1&f=G&l=50&s1=9522155.PN.&OS=PN/9522155RS=PN/9522155
Keywords for this account commodity include: Chemistry, Proinsulin, Proteomics, Peptide Hormones, Peptide Proteins, Accident and Prevention, Biotechnology Companies, Biopharmaceutical Companies, KYTHERA BIOPHARMACEUTICALS INC..
Our letters bear fact-based account of analysis and discoveries from about the world. Copyright 2017, NewsRx LLC
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