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Libertyville, IL, United States

Jina Pharmaceuticals Inc. | Date: 2013-07-16

Drug delivery agents consisting of compounds that facilitate delivery of a wide range of pharmaceuticals.

Jina Pharmaceuticals Inc. | Date: 2010-05-21

The present invention provides compositions containing endoxifen, formulations and liposomes of endoxifen, methods of preparation of such agents and formulations, and use of such agents and formulations for the treatment of a subject having or at risk for psychiatric and neurodegenerative diseases, infectious diseases, fertility disorders, osteoporosis, osteoarthritis, and/or cardiovascular diseases. Specifically, the present invention relates to compositions comprising endoxifen for use in the treatment of such disorders or predisposition to such disorders, for use in manufacture of medicaments for treating such disorders, and methods comprising use of such compositions in such treatments.

Ahmad A.,Jina Pharmaceuticals Inc. | Sheikh S.,Jina Pharmaceuticals Inc. | Taran R.,CHL Apollo Hospital | Srivastav S.P.,Lions Cancer Detection Center | And 8 more authors.
Clinical Breast Cancer | Year: 2014

Background Nanosomal docetaxel lipid suspension formulation was developed to eliminate ethanol and polysorbate 80 from the currently used docetaxel (Taxotere) drug for treatment of cancer patients. NDLS clinical safety and efficacy was evaluated and compared with Taxotere at 75 mg/m2 in metastatic breast cancer patients. Patients and Methods A total of 72 patients were randomized in a ratio of 2:1 (NDLS:Taxotere). Patients treated with NDLS were not premedicated with corticosteroids as required with solvent-based Taxotere. Disease status and tumor response was assessed after every 2 cycles of treatment using Response Evaluation Criteria in Solid Tumors 1.1 guidelines through cycle 6. Results Overall therapeutic response (complete + partial) rate in metastatic breast cancer patients treated with NDLS and Taxotere were 35.5% and 26.3%, respectively, indicating better response in patients treated with NDLS. Patients in the NDLS group were not premedicated but the safety results of NDLS were found to be comparable with Taxotere. Conclusion NDLS formulation with no premedication provides an alternative treatment option for breast cancer patients. © 2014 Elsevier Inc. All rights reserved.

Ahmad A.,Jina Pharmaceuticals Inc. | Shahabuddin S.,Jina Pharmaceuticals Inc. | Sheikh S.,Jina Pharmaceuticals Inc. | Kale P.,Lambda Therapeutic | And 3 more authors.
Clinical Pharmacology and Therapeutics | Year: 2010

Endoxifen is an active metabolite of tamoxifen, a drug used in the treatment of breast cancer. In order to be clinically effective, tamoxifen must be converted to endoxifen by cytochrome P450 2D6 (CYP2D6). A study involving single escalating oral doses was conducted in humans to evaluate the safety, tolerability, and pharmacokinetics (PK) of endoxifen. This is the first study demonstrating that single oral doses of endoxifen are safe and well tolerated and have sufficient bioavailability to reach systemically effective levels in human subjects. Furthermore, it was found that endoxifen is rapidly absorbed and systemically available and that it displays dose proportionality in peak drug concentrations in plasma (Cmax) and area under the concentration-time curve extrapolated from 0 to ∞(AUC 0-∞) over the dose range 0.5-4.0mg. © 2010 American Society for clinical Pharmacology and Therapeutics.

Ali S.M.,Jina Pharmaceuticals Inc. | Ahmad A.,Jina Pharmaceuticals Inc. | Sheikh S.,Jina Pharmaceuticals Inc. | Ahmad M.U.,Jina Pharmaceuticals Inc. | And 7 more authors.
International Immunopharmacology | Year: 2010

Objective: Develop Nanosomal formulation of Tacrolimus to provide safer alternative treatment for organ transplantation patients. Investigate safety, tolerability and pharmacokinetics of Nanosomal Tacrolimus formulation versus marketed Tacrolimus containing polyoxyl 60 hydrogenated castor oil (HCO-60) that causes side effects. Methods: Nanosomal Tacrolimus was prepared in an aqueous system. The particle size was measured by Particle Sizing Systems and structure morphology was determined by freeze-fracture electron microscopy. Investigational safety studies were conducted in mice and rats. Safety and pharmacokinetics of Nanosomal Tacrolimus were also evaluated in healthy human subjects. Results: The morphology of Nanosomal Tacrolimus showed a homogeneous population of nanosized particles with mean particle size of less than 100 nm. A 14 day consecutive administration of Nanosomal Tacrolimus up to 5 and 10 mg/kg dose in rats and mice respectively, resulted in no mortality. Nanosomal Tacrolimus in human studies showed that it is safe and the pharmacokinetics profile is similar to the marketed HCO-60 based Tacrolimus. No significant change in peripheral blood lymphocyte percentage was noted in either mice or healthy human male subjects. Conclusions: Nanosomal Tacrolimus is well characterized product which provides a new treatment option. It contains no alcohol or surfactants like HCO-60. Thus, Nanosomal Tacrolimus presents a new and improved therapeutic approach for organ transplant patients compared to the marketed HCO-60 based Tacrolimus product. © 2009 Elsevier B.V. All rights reserved.

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