Profile: Talon Therapeutics Inc (TLON.OB)

Talon Therapeutics, Inc., incorporated on October 18, 2010, is a California-based biopharmaceutical company. The Company is engaged in developing and commercializing new and differentiated cancer therapies designed to improves and enable current standards of care. The Company's two product candidates target big markets. The Company is developing Marqibo for the treatment of acute lymphoblastic leukemia and other bloods cancers including lymphoma. The Company is also developing menadione topical lotion, a first-in-class compound, for the potential prevention and/or treatment of skin toxicity associated with epidermal growth factor receptor inhibitors.

The Company, as of December 31, 2011, had rights to the product candidates in various stages of development. The products include Marqibo (vincristine sulfate liposomes injection), its product candidate, is a targeted Optisome encapsulated formulation product candidate of the food and drug administration (FDA)-approved anticancer drug vincristine, as of December 31, 2011, was in development primarily for the treatment of adult acute lymphoblastic leukemia (ALL); Menadione Topical Lotion, a supportive care product candidate being developed for the prevention and/or treatment of the skin toxicities associated with the use of epidermal growth factor receptor inhibitors, (EGFRIs), a type of anti-cancer agent used in the treatment of lung, colon, head and neck, pancreatic and breast cancer; Brakiva (topotecan liposome injection), a targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug topotecan, and Alocrest (vinorelbine liposome injection), a targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vinorelbine.

Marqibo (vincristine sulfate liposomes injection)

Marqibo is a targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. The Company is primarily developing Marqibo for the treatment of adult ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies, such as lymphomas and leukemias. The Company's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site.

Marqibo has been evaluated in 18 clinical trials with over 700 patients, including Phase II clinical trials in patients with ALL and non-Hodgkin's lymphoma, or NHL. The Company initiated a global, Phase II clinical trial of Marqibo in adult Philadelphia chromosome negative (Ph) ALL patients in second relapse, or those who have progressed after two or greater prior lines of anti-leukemia therapy. The Company refers to this clinical trial as the rALLy study. The primary outcome measure was complete remission, or CR, or complete remission without full hematologic recovery, which the Company refers to as CRi.

The Company completed the rALLy study in 2010 and announced data at the 2010 Annual Meeting of the American Society of Clinical Oncology. The sample size from the study consisted of 65 evaluable subjects. The analysis of the study data demonstrated an overall response rate (measured by CR, CRi, partial remission and bone marrow blast count normalization without blood count recovery) reported by study investigators in 23 of the 65 evaluable subjects, or 35%. Based on an evaluation by the principal investigator, 13 subjects, or 20%, experienced a CR or CRi. As of the announcement of the study results, the estimated median overall survival in complete responders was 7.7 months, with five subjects having an overall survival of more than one year. The estimated median duration of CR/CRi was 5.4 months. Eleven subjects participating in the rALLy study went on to receive a potentially life-saving stem cell transplant. In November 2011, the Company initiated the United States portion of its global Phase III confirmatory study of Marqibo, named HALLMARQ, in the treatment of patients 60 years of age or older with newly diagnosed ALL.

The Company is also conducting a Phase II study to assess the efficacy of Marqibo in patients with metastatic malignant uveal melanoma as determined by Disease Control Rate (CR, partial response or durable stable disease). On March 2, 2012, the Company entered into an investigator-initiated clinical trial research agreement with The University of Texas M.D. Anderson Cancer Center (MDACC), whereby the Company agreed to provide Marqibo to study the safety and efficacy of Marqibo in certain clinical trial research entitled Hyper-CVAD with Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia.

Menadione Topical Lotion (Supportive Care Product)

Menadione Topical Lotion (MTL), which the Company licensed from the Albert Einstein College of Medicine (AECOM), is a product candidate under development for the treatment and/or prevention of skin rash associated with the use of EGFR inhibitors in the treatment of certain cancers. EGFR inhibitors, which include Tarceva, Erbitux, Iressa, Tykerb and Vectibix, are approved to treat non-small cell lung cancer, pancreatic, colorectal, breast and head and neck cancer. EGFR inhibitors are associated with skin toxicities presenting as acne-like rash on the face, neck and upper-torso of the body in approximately 75% of patients. In August 2011, the Company entered into an agreement with Mayo Clinic pursuant to which, Mayo Clinic will sponsor and conduct a Phase II clinical trial.

Brakiva (topotecan liposome injection)

Brakiva is the Company's product candidate comprised of the anti-cancer drug topotecan encapsulated in Optisomes. Topotecan is FDA-approved for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy, and small cell lung cancer sensitive disease after failure of first-line chemotherapy.

Alocrest (vinorelbine liposome injection)

Alocrest is a Optisomal encapsulated formulation product candidate of the FDA-approved drug vinorelbine, a microtubule inhibitor for use as a single agent or in combination with cisplatin for the first-line treatment of unresectable, advanced non-small cell lung cancer. The Company completed enrollment in a Phase I study of Alocrest in 2008. The trial enrolled 30 adult subjects with confirmed solid tumors refractory to standard therapy or for which no standard therapy was known to exist. The objectives of the Phase I clinical trial includes to assess the safety and tolerability of Alocrest; to determine the maximum tolerated dose of Alocrest; to characterize the pharmacokinetic profile of Alocrest, and to explore preliminary efficacy of Alocrest. The study was conducted at the Cancer Therapy and Research Center and South Texas Accelerated Research Therapeutics (START), both located in San Antonio, Texas and at McGill University in Montreal. Reversible neutropenia, a low white blood cell count, was the dose-limiting toxicity.