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公开(公告)号：US20140315820A1
公开(公告)日：2014-10-23
申请号：US14225011
申请日：2014-03-25
申请人： Gary E. Borodic
发明人： Gary E. Borodic
IPC分类号： C07K14/33
CPC分类号： C07K14/33 , A61K9/0019 , A61K38/04 , A61K38/4893 , A61K47/42
摘要： The present invention provides improved formulations of botulinum toxin that increase delivery of the botulinum toxin to neural and associated tissues and exhibit a higher specific neurotoxicity and higher potency (in LD50 Units) than available formulations of botulinum toxins. These improved formulations enable physicians to treat a wide variety of pathological conditions with a lower toxin load that reduces the risk of inducing an immune response against the toxin and its associated proteins that may ultimately lead to the development of toxin resistance. These benefits are particularly important in the treatment of conditions that require high-dose or chronic administration of botulinum toxin. Additionally, the decreased in LD50 Unit doses of inventive formulations allows for controlled administration limits diffusion. The present invention also provides methods of treating neuromuscular diseases and pain, using low-dose botulinum toxin.
摘要翻译： 本发明提供了改进的肉毒杆菌毒素制剂，其增加肉毒毒素向神经和相关组织的递送，并且比肉毒杆菌毒素的现有制剂显示更高的特异性神经毒性和更高的效力（在LD50单位）。 这些改进的制剂使得医师能够以较低的毒素负荷治疗多种病理状况，降低针对毒素及其相关蛋白的免疫应答的风险，这可能最终导致毒素抗性的发展。 这些益处在治疗需要高剂量或长期施用肉毒杆菌毒素的病症中尤其重要。 另外，本发明制剂的LD50单位剂量的降低允许受控的给药限度扩散。 本发明还提供使用低剂量肉毒杆菌毒素治疗神经肌肉疾病和疼痛的方法。
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2.发明申请公开(公告)号：US20120039862A1
公开(公告)日：2012-02-16
申请号：US13132855
申请日：2009-12-04
申请人： Gary E. Borodic
发明人： Gary E. Borodic
IPC分类号： A61K38/16 , A61P25/28 , A61P25/06 , A61P25/00 , A61P13/08 , A61P19/08 , A61P21/00 , A61P25/14 , A61P13/10
CPC分类号： A61K38/4833 , A61K8/02 , A61K8/24 , A61K8/33 , A61K8/553 , A61K8/64 , A61K8/65 , A61K8/66 , A61K8/8111 , A61K8/8141 , A61K9/0019 , A61K9/08 , A61K38/4893 , A61K47/08 , A61K47/10 , A61K47/24 , A61K47/32 , A61K47/42 , A61K2800/48 , A61K2800/5922 , A61K2800/91 , A61Q19/08 , C12Y304/21005 , C12Y304/24069
摘要： An extended duration pharmaceutical composition including a botulinum neurotoxin, an adhesive agent, and a stabilizing macromolecule. The composition effectively has all the properties to cause chemodenervation through a facial muscle, or other muscle, that predecessor botulinum toxin preparations have had as well as agents which create a fibrotic adhesion on the under surface of facial muscles (or other muscles) to the facial bone (or other bones) so that the facial bone tethers the under surface of the facial muscle, thereby causing fibrosis to the underlying fat pad. The composition can be used to treat various disorders. Methods of modifying facial contour for functional or cosmetic purposes in a human patient are disclosed which involve injecting a therapeutically effective amount of the disclosed compositions. A method of quantifying the extended duration of the compositions is also disclosed.
摘要翻译： 一种延长持续时间的药物组合物，其包含肉毒杆菌神经毒素，粘合剂和稳定性大分子。 该组合物有效地具有通过面部肌肉或其他肌肉引起化学去神经的所有性质，其中前驱肉毒毒素制剂已经具有以及在面部肌肉（或其他肌肉）的下表面上产生纤维粘连的药剂 骨骼（或其他骨骼），使得面部骨骼系于面部肌肉的下表面，从而引起纤维化到下面的脂肪垫。 该组合物可用于治疗各种疾病。 公开了在人类患者中修饰功能或美容目的的面部轮廓的方法，其涉及注射治疗有效量的所公开的组合物。 还公开了一种量化组合物延长持续时间的方法。
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3.发明申请Albumin-Free Botulinum Toxin Based Pharmaceutical Compositions Containing a Hyaluronidase and Methods of Use 审中-公开不含白蛋白的肉毒杆菌毒素基药物组合物含有透明质酸酶及使用方法公开(公告)号：US20090324647A1
公开(公告)日：2009-12-31
申请号：US12083058
申请日：2006-10-11
申请人： Gary E. Borodic
发明人： Gary E. Borodic
CPC分类号： A61K38/47 , A61K9/0019 , A61K9/19 , A61K38/4893 , Y02A50/469 , A61K2300/00
摘要： The present invention provides compositions that contain botulinum toxin and a hyaluronidase, and that lack human or recombinant serum albumin. The present invention also provides methods of administering the pharmaceutical composition to a subject in need thereof.
摘要翻译： 本发明提供含有肉毒杆菌毒素和透明质酸酶并且缺少人或重组血清白蛋白的组合物。 本发明还提供了将药物组合物给予有需要的受试者的方法。
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公开(公告)号：US20090148476A1
公开(公告)日：2009-06-11
申请号：US12318572
申请日：2008-12-31
申请人： Gary E. Borodic
发明人： Gary E. Borodic
CPC分类号： A61K45/06 , A61K38/4893 , A61K2300/00
摘要： Pharmaceutical application of a chemodenervating agent, particularly botulinum toxin, reduces inflammatory response and serves as an anti-inflammatory agent without systemic side effects and with long duration action, on the order of 12-24 weeks. In one embodiment, the effective dosage for allergy provoked inflammation reduction is an order of magnitude less than dosages associated with treatment of regional movement diseases, since the agent works to reduce inflammation by reducing histamine and other preformed mediator releases associated with mast cell degranulation.
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公开(公告)号：US07537773B1
公开(公告)日：2009-05-26
申请号：US09382837
申请日：1999-08-25
申请人： Gary E. Borodic
发明人： Gary E. Borodic
CPC分类号： A61K45/06 , A61K38/4893 , A61K2300/00
摘要： Pharmaceutical application of a chemodenervating agent, particularly botulinum toxin, reduces inflammatory response and serves as an anti-inflammatory agent without systemic side effects and with long duration action, on the order of 12-24 weeks. In one embodiment, the effective dosage for allergy provoked inflammation reduction is an order of magnitude less than dosages associated with treatment of regional movement diseases, since the agent works to reduce inflammation by reducing histamine and other preformed mediator releases associated with mast cell degranulation.
摘要翻译： 化学改造剂，特别是肉毒杆菌毒素的药物应用降低炎症反应，并且用作抗炎剂，而不伴有全身副作用，持续时间长，为12-24周。 在一个实施方案中，引起炎症减轻的过敏的有效剂量比治疗区域性运动疾病的剂量小一个数量级，因为该药剂通过减少与肥大细胞脱粒相关的组胺和其它预先形成的介体释放来减轻炎症。
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公开(公告)号：US11123411B2
公开(公告)日：2021-09-21
申请号：US15834491
申请日：2017-12-07
申请人： Gary E. Borodic
发明人： Gary E. Borodic
IPC分类号： A61P27/02 , C07K16/22 , C07K14/33 , A61K38/48 , A61K45/06 , A61K9/00 , A61K38/17 , A61K39/395
摘要： Formulations and methods of treatment are disclosed for prevention and/or treatment of visual loss from age-related macular degeneration. The disclosed formulations include botulinum neurotoxin (e.g., botulinum neurotoxin or a fragment thereof, either in pure form or with one or more peptide fragments and/or neurotoxin associated proteins). In some embodiments, the disclosed formulations also include one or more anti-VEGF agents. The disclosed formulations may be applied to an intraocular or extraocular region of a patient. If applied to an extra ocular region of a patient, the botulinum-based pharmaceutical formulation may be transported to the intra-ocular region of the patient via axoplasmic transport, thereby allowing the active ingredient(s) to penetrate into the choroid, neuro-retina, and/or retinal pigment epithelium without direct injection into the eye, allowing for improved therapeutic safety by eliminating risk of retinal detachment, retinal break, retinal hemorrhage, and blindness associated with direct injection into the eye.
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公开(公告)号：US11096993B2
公开(公告)日：2021-08-24
申请号：US16015984
申请日：2018-06-22
申请人： Gary E. Borodic
发明人： Gary E. Borodic
摘要： Formulations and methods of treatment are disclosed for prevention and/or treatment of visual loss from age-related macular degeneration. The disclosed formulations include botulinum neurotoxin. The disclosed formulations may be applied to an intraocular or extraocular region of a patient. If applied to an extra ocular region of a patient, the botulinum-based pharmaceutical formulation may then be transported to the intra-ocular region of the patient, allowing the active ingredient(s) to penetrate into the choroid, neuro-retina, and/or retinal pigment epithelium without direct injection into the eye, eliminating risk of retinal detachment, retinal break, retinal hemorrhage, and blindness. The methods described herein allow for increased blood flow to the choroid, which improves removal of metabolites and intra retinal fluid and also serves to arrest, reverse and/or delay early and later stages of age-related macular degeneration.
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8.发明授权Method of detecting botulinum neurotoxin and antibodies that neutralize botulinum neurotoxin action 有权检测肉毒杆菌神经毒素的方法和中和肉毒杆菌神经毒素作用的抗体公开(公告)号：US08940477B2
公开(公告)日：2015-01-27
申请号：US12291411
申请日：2008-11-10
申请人： Eric A. Johnson , Sabine Pellett , William H. Tepp , Gary E. Borodic , David J. Beebe , Amy Paguirigan
发明人： Eric A. Johnson , Sabine Pellett , William H. Tepp , Gary E. Borodic , David J. Beebe , Amy Paguirigan
IPC分类号： C12Q1/00 , C12Q1/68 , G01N33/567 , C12Q1/37
CPC分类号： C12Q1/37 , G01N2333/33
摘要： A highly sensitive method of analyzing a sample for the presence or activity of botulinum neurotoxin (BoNT) or antibodies specific for botulinum neurotoxin is disclosed. In one embodiment, the method comprises the steps of preparing primary non-human mammalian or avian spinal cord cells, and exposing the cells to a test sample, in parallel with a control sample, and examining the extent of cleavage of the intracellular neuronal target protein in both the test and control sample.
摘要翻译： 公开了一种分析样品对肉毒杆菌神经毒素（BoNT）或特异于肉毒杆菌神经毒素的抗体的存在或活性的高度灵敏的方法。 在一个实施方案中，该方法包括以下步骤：与对照样品平行地制备初级非人哺乳动物或禽脊髓细胞，并将细胞暴露于测试样品，并检查细胞内神经元靶蛋白的切割程度 在测试和对照样品中。
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公开(公告)号：US20100279945A1
公开(公告)日：2010-11-04
申请号：US12662186
申请日：2010-04-05
申请人： Gary E. Borodic
发明人： Gary E. Borodic
CPC分类号： C07K14/33 , A61K9/0019 , A61K38/04 , A61K38/4893 , A61K47/42
摘要： The present invention provides improved formulations of botulinum toxin that increase delivery of the botulinum toxin to neural and associated tissues and exhibit a higher specific neurotoxicity and higher potency (in LD50 Units) than available formulations of botulinum toxins. These improved formulations enable physicians to treat a wide variety of pathological conditions with a lower toxin load that reduces the risk of inducing an immune response against the toxin and its associated proteins that may ultimately lead to the development of toxin resistance. These benefits are particularly important in the treatment of conditions that require high-dose or chronic administration of botulinum toxin. Additionally, the decreased in LD50 Unit doses of inventive formulations allows for controlled administration limits diffusion. The present invention also provides methods of treating neuromuscular diseases and pain, using low-dose botulinum toxin.
摘要翻译： 本发明提供了改进的肉毒杆菌毒素制剂，其增加肉毒毒素向神经和相关组织的递送，并且比肉毒杆菌毒素的现有制剂显示更高的特异性神经毒性和更高的效力（在LD50单位）。 这些改进的制剂使医生能够以较低的毒素负荷治疗多种病理状况，降低针对毒素及其相关蛋白的免疫应答的风险，其可能最终导致毒素耐药性的发展。 这些益处在治疗需要高剂量或长期施用肉毒杆菌毒素的病症中尤其重要。 另外，本发明制剂的LD50单位剂量的降低允许受控的给药限度扩散。 本发明还提供使用低剂量肉毒杆菌毒素治疗神经肌肉疾病和疼痛的方法。
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10.发明公开公开(公告)号：US20240189402A1
公开(公告)日：2024-06-13
申请号：US18585914
申请日：2024-02-23
申请人： Gary E. Borodic
发明人： Gary E. Borodic
CPC分类号： A61K38/4893 , A61K9/0019 , A61K9/0048 , A61K38/179 , A61P27/02 , C07K16/22 , C12Y304/24069
摘要： Formulations and methods of treatment are disclosed for prevention and/or treatment of visual loss from age-related macular degeneration. The disclosed formulations include botulinum neurotoxin. The disclosed formulations may be applied to an intraocular or extraocular region of a patient. If applied to an extra ocular region of a patient, the botulinum-based pharmaceutical formulation may then be transported to the intra-ocular region of the patient, allowing the active ingredient(s) to penetrate into the choroid, neuro-retina, and/or retinal pigment epithelium without direct injection into the eye, eliminating risk of retinal detachment, retinal break, retinal hemorrhage, and blindness. Additionally, relative timing of botulinum application and specific staging of wet, exudative macular degeneration relative to the paraorbital applications are disclosed. Further, a mammalian model is proposed to determine the fraction of botulinum most effective at altering VEGF production and associated with suppression of chorio-retinal leakage from macular pathologies.
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