The present invention relates to a process for spray-freeze-drying (SFD) a dispersion of polyelectrolyte complex (PEC) nanoparticles loaded with a protein drug, which yields a powdered product with adequate flowability properties that may readily be processed further into solid dosage forms such as tablets or capsules. The mean particle size of PEC nanoparticles obtained after redispersion of SFD powder or pharmaceutical compositions made from said powder in water is preserved in the nanometer range (<1000 nm), and so is the protein biological activity.

Disclosed herein are compositions and methods for modulating the production of a protein in a target cell. The compositions and methods disclosed herein are capable of ameliorating diseases associated with protein or enzyme deficiencies.

The present invention relates to SNS-595 and methods of treating cancer using the same.

Disclosed herein is a companion diagnostic to predict efficacy of combination lenalidomide and erythropoietin treatment in patients with a erythropoietin (Epo)-refractory, Lower Risk (LR) Non-deletion 5q [Del(5q)] myelodysplastic syndrome (MDS). The method involves assaying erythroid precursors from a biological sample from the subject for a CD45 isoform profile, and treating the subject with a combination of lenalidomide and erythropoietin if the erythroid precursors have a predominance of large CD45RA and CD45RB isoforms compared to small CD45RO isoform.

Disclosed herein is a companion diagnostic to predict efficacy of combination lenalidomide and erythropoietin treatment in patients with a erythropoietin (Epo)-refractory, Lower Risk (LR) Non-deletion 5q [Del(5q)] myelodysplastic syndrome (MDS). The method involves assaying erythroid precursors from a biological sample from the subject for a CD45 isoform profile, and treating the subject with a combination of lenalidomide and erythropoietin if the erythroid precursors have a predominance of large CD45RA and CD45RB isoforms compared to small CD45RO isoform.

In vitro and in vivo application of sub-atmospheric, negative pressure on growth factor starting material, such as whole blood, extracts growth factors from the platelet granules of the growth factor starting material in a non-destructive medium without activating the clotting process. The extracted growth factors are released into a growth factor composition containing blood plasma, extracellular fluid or interstitial fluid depending upon the type and location of the growth factor starting material. The growth factors have a weight of about 70-76 kDaltons and are applied in either a filtered or unfiltered state topically to the area of a surface wound to effect healing. The extracted growth factors are also injected into soft tissue, such as a torn tendon, to promote tissue growth and healing. The growth factors are released in one method from a patient's own blood. In another method the growth factors are released from a whole blood source and freeze dried by lyophilization. Then at a later date, the freeze-dried product is reconstituted by normal saline for treatment of a patient's wound, for use in a surgical procedure, or for tissue regeneration.

In certain aspects, disclosed herein are novel compositions and methods related to either the enhancement or inhibition of erythropoiesis that are useful, for example, in the treatment of anemia or erythrocytosis.

In certain aspects, disclosed herein are novel compositions and methods related to either the enhancement or inhibition of erythropoiesis that are useful, for example, in the treatment of anemia or erythrocytosis.

Cell-free compositions for promoting restoration of tissue function or enhancement of tissue function and methods of stimulating or promoting restoration or enhancement of tissue function using the cell-free compositions. The compositions herein help stimulate endogenous pathways via a subject's own cells effectively for improving tissue function, enhancing tissue function, enhancing cell proliferation, etc. The compositions comprise one or a plurality of therapeutic components such as growth factors, extracellular matrix, DNA, RNA, hormones, drugs, cell surface receptors, enzymes, cytokines, angiogenesis modulating factors, etc., e.g., any material that can effectively activation endogenous pathways in the subject's own cell to a desired effect. The cell-free composition comprises a carrier or is attached to or integrated into and/or within a carrier. The carrier may help provide for containment of the therapeutic components and/or provide for time-release of the therapeutic components of the cell-free composition.

Methods are provided for treating a subject with a therapeutic dose of anti-CD47 agent by administering a primer agent prior to administering a therapeutically effective dose of an anti-CD47 agent to the subject.