Abstract: The disclosure provides compounds, methods, and kits for diagnosis, detection, screening, and imaging of a disease condition (e.g., infection, cancer, tumor, neoplasia), in vitro, ex vivo, and/or in vivo. Certain embodiments include administering a cationic steroid antimicrobial (a “CSA” or “ceragenin”), the CSA including a steroidal backbone and a heterocyclic ring separated from the steroidal backbone by at least 4 atoms (and up to 24 atoms or more), to a subject having or at risk of having a disease condition in an amount effective to diagnose, detect, screen for or image the disease condition in the subject.

Abstract: This disclosure relates to dermal treatment compositions, such as dermal fillers and tissue glues, and injectable compositions that incorporate one or more cationic steroidal antimicrobials (CSAs). The CSAs are incorporated into the dermal treatment compositions to provide effective antimicrobial, anti-inflammatory, analgesic, anti-swelling and/or tissue-healing properties. A treatment composition includes a component formed from a biologically compatible material suitable for injection into and/or application onto tissue at a treatment site. One or more CSA compounds are mixed with the biologically compatible material so that the one or more CSA compounds are incorporated within the composition, forming a reservoir of CSA compounds within the resulting bolus of the treatment composition after injection and/or application.

Abstract: Compositions and methods for preparing stabilized CSA compositions having reduced agglomeration and increased stability. The compositions have increased efficacy in killing microbes and reduced cytotoxicity to mammals. The compositions include a liquid carrier, micelles formed from an amphiphilic material, and CSA molecules encapsulated by the micelles. The CSA compositions can be formed by blending together a solvent or liquid carrier, a plurality of CSA molecules, and a micelle-forming agent and causing or allowing the micelle-forming agent to form micelles encapsulating at least a portion of the CSA molecules so that no more than 25% of the CSA molecules form agglomerates larger than 1 ?m in size. The CSA compositions can be used to treat mammals, such as mammals suffering from microbial diseases or infections.

Abstract: Disclosed herein are methods of treating cancer and/or reducing cellular proliferation in a patient, comprising identifying a patient in need of treatment and administering a therapeutically effective amount of at least one cationic steroid antimicrobial (CSA), or a pharmaceutically acceptable salt thereof. Kits comprising such compositions and instructions on such methods are also contemplated herein.

Abstract: Prodrugs or pharmaceutically acceptable salts, stereoisomers, solvates, or polymorphs thereof include a pharmaceutically and/or diagnostically active cationic steroidal antimicrobial (hereinafter “CSA”) compound or pharmaceutically acceptable salt, stereoisomer, solvate, or polymorph thereof, and one or more cleavable groups (C.G.). Some embodiments include a CSA compound prepared in an inactive or less active form and that is capable of conversion to a fully active form upon administration to a subject, upon preparation of a pharmaceutical formulation containing the CSA composition, and/or upon exposure to physiological conditions. Pharmaceutical compositions include the prodrug or pharmaceutically acceptable salt, stereoisomer, solvate, or polymorph thereof and one or more pharmaceutically acceptable excipients.

Abstract: The invention relates to diagnostic, detection, screening and imaging methods. In various embodiments, methods of diagnosis, detection, screening and imaging include administering a cationic steroid antimicrobial or CSA to a subject having or at risk of having an infection or a hyperproliferative disorder (e.g., a tumor, cancer or neoplasia) in an amount effective to diagnose or detect the infection or the hyperproliferative disorder (e.g., a tumor, cancer or neoplasia) in the subject. In a particular aspect, a detectable CSA, namely CSA-13 labeled with 99mTc is used to detect the presence of an infection.

Abstract: This disclosure relates to sporicidal compositions and uses thereof. The sporicidal compositions include one or more cationic steroidal antimicrobials (CSAs). The sporicidal compositions may be applied to an object to kill or deactivate bacterial spores contacting the sporicidal composition. The object may be a food product, food processing equipment, industrial equipment, or healthcare facility objects. The sporicidal composition may be administered to a subject that has, is suspected to have, or is at risk for an infection associated with spore-forming bacteria.

Abstract: This disclosure describes the use of cationic steroidal antimicrobial (CSA) compounds to prevent microbial fouling of medical implants, including microbial fouling caused by bacterial and/or fungal biofilms. The CSAs are incorporated into the medical implants to provide effective antimicrobial properties. A medical implant includes a component formed from a polymeric material. A plurality of CSA molecules are mixed with the polymeric material so that the CSA molecules are incorporated into the structure of the medical implant as formed. A medical implant can additionally or alternatively include a lubricious coating containing CSA molecules.

Abstract: Particulate ceragenin materials may be manufactured by (i) providing a ceragenin feed material comprised of ceragenin molecules, each having a sterol backbone and a plurality cationic groups attached thereto; (ii) fracturing the ceragenin feed material in a milling apparatus to produce a ceragenin particulate material having a particle size distribution with a median particle size in a range from 5 nm to 20 ?m; and (iii) during fracturing, maintaining the ceragenin feed with a moisture content of less than or equal to 10% by weight.

Abstract: Disclosed herein are methods of treating cancer and/or reducing cellular proliferation in a patient, comprising identifying a patient in need of treatment and administering a therapeutically effective amount of at least one cationic steroid antimicrobial (CSA), or a pharmaceutically acceptable salt thereof. Kits comprising such compositions and instructions on such methods are also contemplated herein.

Abstract: The invention relates to diagnostic, detection, screening and imaging methods. In various embodiments, methods of diagnosis, detection, screening and imaging include administering a cationic steroid antimicrobial or CSA to a subject having or at risk of having an infection or a hyperproliferative disorder (e.g., a tumor, cancer or neoplasia) in an amount effective to diagnose or detect the infection or the hyperproliferative disorder (e.g., a tumor, cancer or neoplasia) in the subject. In a particular aspect, a detectable CSA, namely CSA-13 labeled with 99mTc is used to detect the presence of an infection.

Abstract: Disclosed herein are methods of treating cancer and/or reducing cellular proliferation in a patient, comprising identifying a patient in need of treatment and administering a therapeutically effective amount of at least one cationic steroid antimicrobial (CSA), or a pharmaceutically acceptable salt thereof. Kits comprising such compositions and instructions on such methods are also contemplated herein.

Abstract: Cationic steroidal antimicrobials (“CSAs” or “ceragenins”) and methods of making and using the same. Particularly advantageous uses include treating infections in patient and sub-patient populations, especially those having a bone disease, a broken bone, a bone infection, or a bone implant.

Abstract: Increasing fertility in a mammal utilizes cationic steroidal antimicrobial (CSA) compounds and CSA-containing compositions. Such treatment in a mammal includes administering a formulation (e.g., lavage and/or infusion) including at least one CSA compound, or pharmaceutically acceptable salt thereof, to the reproductive structure(s) of the mammal (e.g., horse, dairy cow, human, etc.). The formulation may be applied topically as lavage and/or infusion to desired reproductive structures, such as the vagina, cervix, uterus, penis, or combinations thereof. The formulation may kill both planktonic and biofilm forms of sperm killing microbes, and may at least partially break up a microbial plaque or film located within any of the reproductive structures (e.g., the uterus).

Abstract: This disclosure relates to dermal treatment compositions, such as dermal fillers and tissue glues, and injectable compositions that incorporate one or more cationic steroidal antimicrobials (CSAs). The CSAs are incorporated into the dermal treatment compositions to provide effective antimicrobial, anti-inflammatory, analgesic, anti-swelling and/or tissue-healing properties. A treatment composition includes a component formed from a biologically compatible material suitable for injection into and/or application onto tissue at a treatment site. One or more CSA compounds are mixed with the biologically compatible material so that the one or more CSA compounds are incorporated within the composition, forming a reservoir of CSA compounds within the resulting bolus of the treatment composition after injection and/or application.

Abstract: Disclosed herein are methods of treating fungal infections in a patient, comprising identifying a patient in need of treatment and administering a therapeutically effective amount of at least one cationic steroid antimicrobial (CSA), or a pharmaceutically acceptable salt thereof. Kits comprising such compositions and instructions on such methods are also contemplated herein.

Abstract: Disclosed herein are cationic steroidal antimicrobials (“CSA compounds” or “ceragenins”) and methods of making the same. Particularly advantageous methods are identified for the synthesis of CSA compounds. CSA compounds may be formulated for treating subjects with ailments responsive to CSA compounds, including but not limited to treating bacterial infections. Accordingly, some embodiments include formulations and methods of administering CSA compounds.

Abstract: Disclosed herein are methods of promoting osteogenesis in a subject, comprising administering a composition comprising a therapeutically effective amount of at least one cationic steroid antimicrobial (CSA). Also disclosed herein are methods of promoting osteogenesis in a subject in need of such promotion, comprising administering a composition comprising a therapeutically effective amount of at least one CSA. Additionally, disclosed herein are compounds and compositions comprising at least one CSA, or a pharmaceutically acceptable salt thereof, for use in the treatment of bone disease or the treatment of broken bones. Kits comprising such compositions and instructions on such methods are also contemplated herein.

Abstract: Methods for cleaning or disinfecting water delivery systems, self-cleaning or self-disinfecting water delivery systems, and inserts for use in cleaning or disinfecting water delivery systems utilize cationic steroidal antimicrobial (CSA) molecules to kill microbes and/or break up biofilms within water delivery systems. The methods and systems involve adding CSA molecules to water to form an aqueous CSA composition and passing the aqueous CSA composition through the water delivery system, such as a water storage vessel and/or water delivery line to clean or disinfect the water delivery system. CSA molecules can be added to a water storage vessel, water delivery line, or well, such as by a solid or liquid CSA composition. A CSA-eluting composition may provide CSA molecules to water to form an aqueous CSA composition that passes through or is stored within the water delivery system. CSA molecules provided to agricultural animals in drinking water may improve animal health.

Abstract: Disclosed herein are acid addition salts of cationic steroidal antimicrobials (“CSAs” or “ceragenins”) and methods of making the same. Particularly advantageous salt forms are identified, such as 1,5-naphthalenedisulfonic acid addition salts and sulfate addition salts. The acid addition salts may be formulated for treating subjects with ailments responsive to CSAs, including but not limited to treating bacterial infections. Accordingly, some embodiments include formulations and methods of administering acid addition salts of CSAs.