Methods of formulating live biotherapeutics are disclosed in which a deficiency or excess of a specific bacterial strain in a person's microbiome is identified by comparing a gene-specific characterization of the person's microbiome against a comprehensive, non-redundant reference gene catalog, and the biotherapeutic is formulated by selecting bacteria to address the deficiency or excess. Embodiments include the formulation of live biotherapeutics for improving the health of a person's vaginal microbiome, i.e. using a vaginal reference gene catalog, and may be suitable for ameliorating, treating, or preventing a malignancy such as a cancer of the female genitourinary system.

Methods of formulating live biotherapeutics are disclosed in which a deficiency or excess of a specific bacterial strain in a person's microbiome is identified by comparing a gene-specific characterization of the person's microbiome against a comprehensive, non-redundant reference gene catalog, and the biotherapeutic is formulated by selecting bacteria to address the deficiency or excess. Embodiments include the formulation of live biotherapeutics for improving the health of a person's vaginal microbiome, i.e. using a vaginal reference gene catalog, and may be suitable for ameliorating, treating, or preventing a malignancy such as a cancer of the female genitourinary system.

A method of treating a pregnant female subject includes administering to the pregnant female subject an effective amount of a Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) inhibitor, wherein the effective amount of the GM-CSF inhibitor is effective to reduce, prevent or delay preterm birth.

A method of treating a pregnant female subject includes administering to the pregnant female subject an effective amount of a Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) inhibitor, wherein the effective amount of the GM-CSF inhibitor is effective to reduce, prevent or delay preterm birth.

A therapeutic agent for the treatment of toxemia, preeclampsia and eclampsia and a method for preparing the therapeutic agent are disclosed. The therapeutic agent is a stable pharmaceutical preparation containing, but not limited to, digestive/pancreatic enzymes. The therapeutic agent may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic agent may be made orally, through injection, by adherence of a medicated patch or by other methods. Further, a method of using the presence of chymotrypsin in the maternal GI tract as a biomarker, to determine the likelihood of developing preeclampsia, a pregnancy induced hypertension, and eclampsia/toxemia is disclosed.

The instant invention provides various formulations comprising combinations of immunostimulating oligonucleotides, polycationic carriers, sterols, saponins, quaternary amines, TLR-3 agonists, glycolipids, and MPL-A or analogs thereof in oil emulsions, use thereof in preparations of immunogenic compositions and vaccines, and use thereof in the treatment of animals.

The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

A method of treating recurrent spontaneous abortions or repeated implantation failures in a human female subject, comprising providing a composition including a combination of fatty acids or esters thereof as the active ingredients, wherein the human female subject has at least 12% of peripheral blood NK cells in total peripheral blood cells, and/or the cytotoxicity of the peripheral blood NK cells is at least 10% higher than a mean cytotoxicity of a control population of healthy human females of reproductive age without a reproductive failure and who have given birth to at least one child; orally administering the composition for 15 to 70 days, wherein the total amount of fatty acids or esters, administered per day, is from 0.03 g/kg 1 g/kg of body weight, calculated as fatty acids so as to reduce an immune-mediated sub-fertility for the human female subject.

A method of treating recurrent spontaneous abortions or repeated implantation failures in a human female subject, comprising providing a composition including a combination of fatty acids or esters thereof as the active ingredients, wherein the human female subject has at least 12% of peripheral blood NK cells in total peripheral blood cells, and/or the cytotoxicity of the peripheral blood NK cells is at least 10% higher than a mean cytotoxicity of a control population of healthy human females of reproductive age without a reproductive failure and who have given birth to at least one child; orally administering the composition for 15 to 70 days, wherein the total amount of fatty acids or esters, administered per day, is from 0.03 g/kg 1 g/kg of body weight, calculated as fatty acids so as to reduce an immune-mediated sub-fertility for the human female subject.

The present invention relates to an isolated specific binding molecule which binds human Anx-A1 and comprises the complementarity-determining regions (CDRs) VLCDR1, VLCDR2, VLCDR3, VHCDR1, VHCDR2 and VHCDR3, wherein each of said CDRs has an amino acid sequence as follows: VLCDR1 has the sequence set forth in SEQ ID NO: 1, 36 or 37; VLCDR2 has the sequence set forth in SEQ ID NO: 2; VLCDR3 has the sequence set forth in SEQ ID NO: 3; VHCDR1 has the sequence set forth in SEQ ID NO: 4; VHCDR2 has the sequence set forth in SEQ ID NO: 5; and VHCDR3 has the sequence set forth in SEQ ID NO: 6; or, for each sequence, an amino acid sequence with at least 85% sequence identity thereto. The specific binding molecule disclosed is therapeutically useful and in particular may be used in therapy for T-cell mediated diseases, including autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus, obsessive compulsive disorder (OCD), and OCD-related diseases, such as anxiety disorders.