Abstract: A process for the production of fat-encapsulated follistatin. The process includes steps of a) metering fat having a melting point of at least 40° C. into an extruder, b) heating the fat in the extruder during rotation of the at least one screw, c) metering the follistatin into the extruder barrel to produce a flowable mixture, d) cooling the flowable mixture in a downstream adjacent section of the extruder barrel, e) subsequently discharging the mixture through an extruder die, and f) comminuting the mixture after it discharges from the extruder die.

Abstract: The present invention relates to treating one or more estrogen related diseases while preventing or reducing the likelihood of developing estrogen deficiency related side effects, wherein the composition comprises administering a therapeutically effective amount of a Gn RH antagonist to a patient in need of the treatment, and wherein the amount of Gn RH antagonist is sufficient for providing a mean endogenous serum estradiol level of between about 20 pg/ml and 60 pg/ml, preferably between 30 pg/ml and 50 pg/m, in the patient in a treatment period of at least four weeks, without relying on “add-back” therapy. The composition and method are simple, effective and will accordingly both increase patient acceptance and compliance of therapy.

Abstract: Disclosed herein are compositions and methods useful for the diagnosis, assessment, and characterization of endometriosis in a subject in need thereof, based upon the expression level of at least one miRNA that is associated with endometriosis.

Abstract: Provided herein are formulations that can be effective to kill a pancreatic cancer cell that can include fendiline and a MET inhibitor, an aurora-ABC inhibitor, or an autophagy inhibitor. Also provided herein are methods of treating pancreatic cancer or a symptom thereof in a subject in need thereof, where the method can include the step of administering fendiline and a MET inhibitor, an aurora-ABC inhibitor, or an autophagy inhibitor.

Abstract: The present invention provides peptides containing a structure in which a portion of the dominant negative peptide of BIG3 which inhibits the interaction between BIG3 and PHB2 is substituted with stapling structure(s). Peptides of the present invention have excellent cell growth inhibitory actions. Furthermore, their cell growth inhibitory actions continue for a longer time than the actions of peptides without stapling structures. Therefore, these peptides have features suitable for clinical applications in cancer therapy.

Abstract: The present invention is directed to a method of using dehydroepiandrosterone to treat a human female with diminished ovarian reserve. The method includes administering about 25 milligrams three times a day of dehydroepiandrosterone per day to the female for at least four weeks to reduce human embryo aneuploidy. The present invention further is directed to a method of treating a human female with diminished ovarian reserve to improve the female's diminished ovarian reserve.

Abstract: The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

Abstract: A transdermal delivery system comprising a composition comprising a physiologically active agent and a penetration enhancer wherein the penetration enhancer comprises a combination of (i) an ester of salicylic acid, preferably selected from the C6 to C30 aliphatic ester of salicylic acid and (ii) polyethylene glycol (PEG) of average molecular weight no more than 300.

Abstract: Methods and compositions for treating, preventing, or diagnosing disorders related to reproduction in male mammals, preferably humans, are provided. The methods generally involve modulation of the OST-PTP signaling pathway or the PTP-1B signaling pathway involving gamma-carboxylase and osteocalcin. Disorders amenable to treatment by the methods include, but are not limited to, male infertility, low sperm count, impaired sperm motility, impaired sperm viability, low testosterone levels, reduced libido, erectile dysfunction, underdevelopment of testes, and excess apoptosis in testes.

Abstract: The invention is directed to a transdermal drug delivery composition which includes at least one physiologically active agent; and at least one volatile solvent; and at least one viscosity modulating agent. The invention extends to methods of administering such a composition to a subject and treatment of subjects using the composition.

Abstract: A therapeutic or bioeffecting film delivery system which includes nanoparticles having actives bound to or associated with the nanoparticles and which when administered allow the active to perform a therapeutic or bioeffecting function.

Abstract: Formulations and methods for transdermal drug delivery compositions that include synergistic combination of three pharmaceutical active ingredients (APIs), such as testosterone, anastrozole, and HCG are disclosed. TBTC of the present disclosure may be indicated for reducing symptoms of testosterone deficiency. Disclosed TBTC may include permeation enhancers that may improve penetration of testosterone, anastrozole, and HCG in human skin. Permeation enhancer compositions within TBTC may include oils from amazon rainforest such as Pracaxi oil, Plukenetia volubilis seed oil, Inaja oil, and Patauá oil, which includes behenic and oleic fatty acids that may provide penetration power. TBTC may include organic solvents as transdermal penetration enhancers. Additionally, TBTC may include physiological lipids, phospholipids, and one or more butters rich in linoleic acid and linolenic acid that may also provide penetration power with restorative benefits to the skin.

Abstract: The subject invention provides improved testosterone gel formulations.

Abstract: This invention provides transcription regulatory control sequences, the activity of which function as biomarkers for a variety of biological responses. This invention also provides expression constructs in which a biomarker transcription regulatory sequence is operably linked with a sequence for a reporter. Cells that comprise these expression constructs can be used in assays to identify conditions that modulate activity of the biological response.

Abstract: Provided is a novel cancer-treating agent which can be used as a novel choice for the treatment of cancer. Specifically provided are: a peptide that inhibits binding of ERAP1 polypeptide to PHB2 polypeptide, which comprises a binding site of the ERAP1 polypeptide to the PHB2 polypeptide, and a pharmaceutical composition comprising the peptide. In addition, provided is a method for screening a drug candidate for treating and/or preventing cancer using inhibition of the binding of the ERAP1 polypeptide to PP1? polypeptide, PKA polypeptide or PKB polypeptide as an index.

Abstract: The invention provides methods for predicting an increased risk or probability of developing endometriosis in a patient based upon the patient's KRAS variant status.

Abstract: The present invention relates to the use of a container, made of an inorganic additive containing plastic material, for reducing physical/chemical interaction between the container and an oil, fat and/or wax containing formulation contained therein.

Abstract: Provided are methods, reagents, and kits for evaluating cancer, such as prostate cancer, in a subject. Disclosed methods of evaluating cancer include methods of diagnosing cancer, methods of prognosticating cancer and methods of assessing the efficacy of cancer treatment. The methods include assaying a biological sample for methylation of a CpG island associated with specified genes. Provided reagents and kits include primers suitable for amplifying at least a portion of a target CpG islands associated with specified genes.

Abstract: The present invention provides compositions, methods, and kits for improving health in a woman having elevated SHBG levels, or who is receiving oral estrogen supplementation, by non-orally administering an effective amount of an androgenic steroid. Further, the present invention provides compositions, methods, and kits for coadministering an effective amount of an orally administered estrogen and an effective amount of a non-orally administered androgenic steroid for women in need of estrogen supplementation.

Abstract: The present invention relates to novel uses of a construct consisting of virus-like particle (VLP) structure chemically coupled to a fragment of the AD-1-42 peptide and its pharmaceutically acceptable salts (hereinafter CONSTRUCT), in particular to dosage regimens, modes of and dosage forms for the administration of a CONSTRUCT for the treatment of patients suffering from dementia.

Abstract: A combination agent containing an LHRH receptor agonist or antagonist and an androgen receptor agonist, which is useful as an agent for the prophylaxis or treatment of hormone-dependent diseases and the like, is provided.

Abstract: A method is provided for treatment of disorders involving hyperproliferative cells, such as malignancies, advanced stage solid tumors like glioblastoma multiforme, and non-malignant hyperproliferative pathological conditions such as adult macular degeneration. A short range, unselective cell killing radiotherapeutic substance is administered, optionally in a spatially defined volume of tissue, optionally in combination with a mitogenic agent that stimulates or induces DNA biosynthesis. In this way, the percentage of hyperproliferative that are susceptible to killing by the radiotherapeutic agent is increased. Cancer stem cells can be induced to enter S phase with the mitogenic agent, then killed with the radiotherapeutic agent.

Abstract: Provided herein are glucagon superfamily peptides conjugated with NHR ligands that are capable of acting at a nuclear hormone receptor. Also provided herein are pharmaceutical compositions and kits of the conjugates of the invention. Further provided herein are methods of treating a disease, e.g., a metabolic disorder, such as diabetes and obesity, comprising administering the conjugates of the invention.

Abstract: The invention is directed to a transdermal drug delivery composition which includes at least one physiologically active agent; and at least one volatile solvent; and at least one viscosity modulating agent. The invention extends to methods of administering such a composition to a subject and treatment of subjects using the composition.

Abstract: A composition having antimicrobial activity is provided. The composition includes a compound mixture obtained from pulverized and/or extracted wood material that contains polyphenols (i) lignans, (ii) stilbenes and (iii) oligomers of lignans, stilbenes juvabiones or flavonoids. The cytotoxicity of the polyphenols in the compound mixture is at least ten times lower compared to butylated hydroxytoluene (BHT) and does not irritate the skin in a so-called single patch test at 0.1 wt %. The composition further includes an antimicrobial agent such as betulin, betulonic acid, betulinic acid, betuloinic acid, resveratrol or ethylhexyl glyceryl. The composition can be used in cosmetic and hair care products.

Abstract: A polypeptide comprising an androgen binding region, the androgen binding region capable of binding to an androgen at a sufficient affinity or avidity such that upon administration of the polypeptide to a mammalian subject the level of biologically available androgen is decreased. Specifically disclosed is an AR IgG1 Fc fusion protein, comprising the androgen binding domain of human androgen receptor and the Fc region of IgG. This fusion protein is used in the treatment of prostate cancer and testosterone flare.

Abstract: Antagonistic peptides of GnRH having improved water solubility are disclosed. These peptides are capable of suppressing serum testosterone levels in vivo to chemical castration levels of ?0.5 ng/ml. Stable, filter sterilizable, non-gelling solutions containing the GnRH antagonists at least at levels typically used in sustained release formulations also are disclosed, as is a method of increasing the solubility of GnRH antagonist in a polymer containing dispersed phase, which method comprises addition of an acid to the dispersed phase.

Abstract: The present invention is directed to methods of treating vasomotor symptoms in castrated prostatic cancer patients in need of treatment, comprising administering about 15 mg or less of cyproterone acetate per day to the patients. The present invention is further directed to dosage forms comprising about 1 mg to about 15 mg of cyproterone acetate and a package comprising a plurality of dosage forms comprising about 1 mg to about 15 mg of cyproterone acetate.

Abstract: Amphipathic lytic peptides are ideally suited to use in a ligand/cytotoxin combination to specifically inhibit cells that are driven by or are dependent upon a specific ligand interaction; for example, to induce sterility or long-term contraception, or to attack tumor cells, or to selectively lyse virally-infected cells, or to attack lymphocytes responsible for autoimmune diseases. The peptides act directly on cell membranes, and need not be internalized. Administering a combination of gonadotropin-releasing hormone (GnRH) (or a GnRH agonist) and a membrane-active lytic peptide produces long-term contraception or sterilization in animals in vivo. Administering in vivo a combination of a ligand and a membrane-active lytic peptide kills cells with a receptor for the ligand. The compounds are relatively small, and are not antigenic. Lysis of gonadotropes has been observed to be very rapid (on the order of ten minutes.) Lysis of tumor cells is rapid.

Abstract: The present invention relates to a method of treating infertility in a female mammal that involves controlled ovarian hyperstimulation. The method includes administering to the female a combination of (i) an FSH substance in an amount effective to stimulate follicular development and (ii) a steroid in an effective amount to inhibit or suppress the secretion of luteinising hormone. The steroid can be substances represented by the following formula in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 15 carbon atoms; each of R5, R6, R7 is a hydroxyl group; no more than 3 of R1, R2, R3, R4 are hydrogen atoms; derivatives of the aforementioned steroid substances; or mixtures of one or more of the aforementioned substances or derivatives.

Abstract: Provided herein are four polypeptides, named PRT5, PRT6, PRT7 and PRT8, the nucleic acids encoding the same, compositions comprising the proteins, as well as their uses in therapeutic and diagnostic methods. Antibodies which specifically recognize the polypeptides are also provided, as well as their uses. Characterization of each protein showed that PRT5 and PRT8 are involved in glucose metabolism, PRT6 is involved in androgen regulation, while PRT7 correlates with cancer.

Abstract: A method of therapeutic management of infertility by programming of controlled ovarian stimulation and assisted reproductive procedures is disclosed containing the steps of a) suppression of premature ovulation with an LHRH-antagonist in controlled ovarian stimulation and assisted reproductive techniques with multiple follicle and oocyte development; b) programming the start of controlled ovarian stimulation by the administration to a patient of progestogen only-preparations or, alternatively, combined oral contraceptive preparations; c) exogenous stimulation of the ovarian follicle growth; d) ovulation induction with HCG, native LHRH, LHRH-agonists or recombinant LH; and e) application of assisted reproduction techniques, especially of IVF, ICSI, GIFT, ZIFT or by intrauterine insemination by sperm injection, wherein onset of the patient's menstrual cycle and of controlled ovarian stimulation are programmed in order to perform oocyte pickup and fertilization procedures during Mondays to Fridays.

Abstract: Provided herein are methods to treat estrogen deficiency in mammals by administering amylin agonist compounds. Also provided herein are methods to treat obesity and overweight in estrogen-deficient mammals; methods to reduce or maintain body weight and/or body fat in estrogen-deficient mammals; and methods to increase Bdnf levels in mammals by administering effective amounts of amylin agonist compounds. The estrogen deficiency may be caused by menopause, perimenopause, post-menopause, ovarian dysfunction, an overectomy, a hysterectomy, and the like. The amylin agonist compounds may be any known in the art or described herein, such as pramlintide, davalintide, or SEQ ID NO: 142.

Abstract: Provided are methods relating to the use of CDP-therapeutic agent conjugates for the treatment of autoimmune disease, inflammatory disease, or cancer. Also provided are CDP-therapeutic agent conjugates, particles comprising CDP-therapeutic agent conjugates, and compositions comprising CDP-therapeutic agent conjugates.

Abstract: A prostate cancer progression inhibitor comprises 4-(4-cyano-2-{[2-(4-fluoro-1-naphthyl)propanoyl]amino}phenyl)butyric acid, a salt thereof, a solvate thereof, or a prodrug thereof. 4-(4-Cyano-2-{[2-(4-fluoro-1-naphthyl)propanoyl]amino}phenyl)butyric acid is useful as a prostate cancer progression inhibitor because this butyric acid has, for example, a growth inhibiting effect and a hormone responsiveness recovering effect on prostate cancer that has acquired hormone resistance.

Abstract: One aspect of the present invention relates to a method of hormone replacement in mammals, which method comprises the oral administration of an estrogenic component and a progestogenic component to a mammal in an effective amount to prevent or treat symptoms of hypoestrogenism, wherein the estrogenic component is selected from the group consisting of substances represented by the above formula in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 1-5 carbon atoms; each of R5, R6, R7 is a hydroxyl group; and no more than 3 of R1, R2, R3, R4 are hydrogen atoms; precursors capable of liberating a substance according to the aforementioned formula when used in the present method; and mixtures of one or more of the aforementioned substances and/or precursors.

Abstract: The invention relates to compounds that include peptides that inhibit estrogen receptor dependent cell proliferation. The compounds of the invention are useful for treating cell proliferative disorders or physiological conditions characterized by undesirable or unwanted estrogen induced cell proliferation, including breast cancer.

Abstract: Methods for long-term lowering of lipid levels in human subjects and for the treatment of conditions associated with elevated LDL-cholesterol and elevated ApoB are provided.

Abstract: The present invention provides a polypeptide comprising an estrogen or androgen binding region, the binding region capable of binding to an estrogen or androgen at a sufficient affinity or avidity such that upon administration of the polypeptide to a mammalian subject the level of biologically available estrogen or androgen is decreased. The invention also provides for the treatment or prevention of cancers such as ovarian cancer, breast cancer and endometrial cancer using the polypeptides.

Abstract: This invention relates to a transdermal drug delivery device that comprises an active ingredient (Al) layer, having a skin contacting surface and a non-skin contacting surface and comprising a volatile component, a release liner impermeable to the volatile component adjacent the skin contacting surface of the Al layer having a pe?meter that extends beyond the perimeter of the Al layer in all directions, and an overlay comprising a pressure sensitive adhesive (PSA) that does not absorb the volatile component adjacent the non-skin contacting surface of the Al layer having a pe?meter of which extends beyond the penmeter of the Al layer in all directions, wherein the release liner and the PSA of the overlay are in contact with and adhered to each other around the pe?meter of the Al layer to form a seal that reduces or prevents volatile component loss.