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Spectrum, Talon Therapeutics and Hana Biosciences Inc. | Date: 2011-07-05

Pharmaceutical preparations, namely, drug delivery systems comprising nanoparticles that encapsulate and permit the sustained release of a wide variety of therapeutic agents. Drug delivery systems.

Kaplan L.D.,University of California at San Francisco | Deitcher S.R.,TALON THERAPEUTICS | Silverman J.A.,TALON THERAPEUTICS | Morgan G.,Royal Cancer Hospital
Clinical Lymphoma, Myeloma and Leukemia | Year: 2014

Background VSLI (Marqibo) is active in advanced non-Hodgkin lymphoma (NHL) and untreated aggressive NHL. Because of its favorable hematologic toxicity profile, VSLI might be useful in patients unable to tolerate myelosuppressive therapies. Patients and Methods Twenty-two patients with heavily pretreated, advanced CD20+ DLBCL or MCL were treated with VSLI 2.0 mg/m 2, without a dose cap, every 2 weeks plus 4 weekly doses of rituximab 375 mg/m2. ORR, complete response (CR), or partial response (PR), was the primary end point. Secondary end points included response duration, time to progression (TTP), and OS. Safety variables included adverse events and neurologic assessments. Results The ORR was 13 of 22 (59%); 6 patients achieved a CR (27%), and 7 patients achieved a PR (32%). Median response duration, TTP, and OS were 147 days, 121 days, and 322 days, respectively. The median number of VSLI doses was 5, the median individual VSLI dose was 3.5 mg, and the maximum cumulative VSLI dose was 43 mg. Grade 3 peripheral neuropathy, febrile neutropenia, and constipation were reported in 4, 2, and 1 patients, respectively. Conclusion VSLI plus rituximab resulted in durable responses in patients with heavily pretreated advanced stage DLBCL and MCL. The toxicity profile was predictable and manageable with limited hematologic toxicity. Despite near-universal previous VCR exposure (96%) and doses of VSLI unachievable with standard VCR treatment, peripheral neuropathy and constipation were modest. This study supports further evaluation of VSLI as a component of DLBCL management. © 2014 Elsevier Inc. All rights reserved.

Silverman J.A.,TALON THERAPEUTICS | Reynolds L.,ICON Development Solutions | Deitcher S.R.,TALON THERAPEUTICS
Journal of Clinical Pharmacology | Year: 2013

Vincristine sulfate liposome injection (VSLI,) is a sphingomyelin and cholesterol nanoparticle formulation of vincristine sulfate (VCR) that was designed to overcome the dosing and pharmacokinetic limitations of standard VCR. In contrast to the rapid CL and wide tissue distribution of non]liposomal VCR, VSLI circulates in plasma for a prolonged period of time, with a slow CL of 345 mL/h and relatively small Vd of 3,570 mL. This facilitates enhanced and prolonged tumor]tissue delivery of VCR. The maximum tolerated dose of VSLI, 2.25 mg/m2 once per week without a dose cap, enables individual and cumulative VCR exposure unachievable with non]liposomal VCR at its labeled dose of 1.4 mg/m2. VSLI is associated with a dose]dependent peripheral neurotoxicity albeit at doses that are two to three times that of standard VCR. VCR dose intensification with VSLI correlated with an increased probability of overall response and a strong trend towards increased complete response in adults with relapsed and/or refractory acute lymphoblastic leukemia. Overall, VSLI improves the therapeutic index by facilitating increased dose intensification while maintaining a predictable and manageable safety profile. © 2013, The American College of Clinical Pharmacology.

Cancer Chemotherapy and Pharmacology | Year: 2013

Vincristine (VCR) is a mainstay of treatment of hematologic malignancies and solid tumors due to its well-defined mechanism of action, demonstrated anticancer activity and its ability to be combined with other agents. VCR is an M-phase cell cycle-specific anticancer drug with activity that is concentration and exposure duration dependent. The pharmacokinetic profile of standard VCR is described by a bi-exponential elimination pattern with a very fast initial distribution half-life followed by a longer elimination half-life. VCR also has a large volume of distribution, suggesting diffuse distribution and tissue binding. These properties may limit optimal drug exposure and delivery to target tissues as well as clinical utility as a single agent or as an effective component of multi-agent regimens. Vincristine sulfate liposome injection (VSLI), Marqibo®, is a sphingomyelin and cholesterol-based nanoparticle formulation of VCR that was designed to overcome the dosing and pharmacokinetic limitations of standard VCR. VSLI was developed to increase the circulation time, optimize delivery to target tissues and facilitate dose intensification without increasing toxicity. In xenograft studies in mice, VSLI had a higher maximum tolerated dose, superior antitumor activity and delivered higher amounts of active drug to target tissues compared to standard VCR. VSLI recently received accelerated FDA approval for use in adults with advanced, relapsed and refractory Philadelphia chromosome-negative ALL and is in development for untreated adult ALL, pediatric ALL and untreated aggressive NHL. Here, we summarize the nonclinical data for VSLI that support its continued clinical development and recent approval for use in adult ALL. © 2012 The Author(s).

Talon Therapeutics and Hana Biosciences Inc. | Date: 2010-07-13

Physician prescribed pharmaceutical preparations for use in the treatment of cancer.

Talon Therapeutics | Date: 2012-06-28

This invention relates to improved liposomal camptothecin compositions and methods of manufacturing and using such compositions for treating neoplasia and for inhibiting angiogenesis.

Talon Therapeutics | Date: 2011-02-01

This invention provides methods for treating neoplasias in a mammal. In particular, the invention provides methods for treating various types of lymphomas, including relapsed forms of non-Hodgkins Lymphoma. These methods involve the administration of liposome encapsulated vinca alkaloids, e.g., vincristine, to a mammal with a lymphoma.

Talon Therapeutics and Hana Biosciences Inc. | Date: 2010-08-25

Pharmaceutical preparations for the prevention and treatment of cancer and related symptoms.

Talon Therapeutics | Date: 2011-05-06

Pharmaceutical preparations, namely, drug delivery systems comprising nanoparticles that encapsulate and permit the sustained release of a wide variety of therapeutic agents; drug delivery systems.

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