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Inching Towards One Dollar Mark...


Talon Therapeutics Inc. (TLON.OB), formerly Hana Biosciences Inc., is a development stage pharmaceutical company with a focus on cancer treatments, and is quoted on the OTC Bulletin Board. Talon shares rose more than 28 percent yesterday to close at $0.94, following an agreement with FDA for a planned phase III study of its patented lead product candidate Marqibo.

For readers who are new to Talon Therapeutics, here's what to expect in the coming months...

On July 18, Talon submitted a New Drug Application for Marqibo seeking FDA's accelerated approval in relapsed, acute, Philadelphia chromosome negative
(Ph-) acute lymphoblastic leukemia in adults.

Marqibo consists of vincristine sulfate encapsulated in the aqueous core of proprietary, sphingomyelin-based liposome called Optisomes. Vincristine is FDA-approved under the name Oncovin and marketed by Eli Lilly & Co. (LLY) for acute lymphoblastic leukemia, or ALL, and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphoma and leukemia. Marqibo - the encapsulation formulation of Vincristine is designed to enhance efficacy with the potential for reduced toxicity.

The NDA submission was based on a phase II pivotal trial, nicknamed RALLY study, which demonstrated that Marqibo resulted in an overall response rate of 35 percent and overall complete response (CR) and CR with incomplete blood count recovery (CRi) rate of 20 percent with side effects that were predictable and manageable in patients with advanced relapsed, adult Ph(-) acute lymphoblastic leukemia.

According to the RALLY trial results, the estimated median overall survival in complete responders was 7.4 months, with five patients having an overall survival greater than one year. The estimated median duration of CR/CRi was 5.3 months. The lead investigator of the study, Susan O'Brien, is of the view that Marqibo's CR/CRi rate of 20 percent would be an extremely important step forward in the treatment of adult acute lymphoblastic leukemia, because based on historical data with single-agent therapy, the CR/CRi rate in such an advanced leukemia population is no more than 4 percent.

By the middle of next month ( mid-September) Talon expects to know whether or not its Marqibo NDA for acute lymphoblastic leukemia has been accepted for filing by the FDA.

Marqibo is also being evaluated as a potential treatment for adults and children with newly diagnosed hematologic cancers including acute lymphoblastic leukemia and non-Hodgkin's lymphoma. According to analysts, sales potential of Marqibo in the indication of acute lymphoblastic leukemia alone, could be in excess of $100 million per year.

Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult acute lymphoblastic leukemia from the FDA. Marqibo has also received orphan drug designation in adult leukemia from the European Medicines Evaluation Agency.

Meanwhile, yesterday (Aug.29) the company announced that it has reached an agreement with the FDA regarding a special protocol assessment, or SPA, for its planned phase III study of Marqibo in adults with newly diagnosed Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia.

The phase III study now under SPA, dubbed HALLMARQ (Halting newly diagnosed Adult acute Lymphoblastic Leukemia with Marqibo containing chemotherapy), is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo.

The company touts receiving an SPA from the FDA as a major accomplishment, and initial clinical site openings for the HALLMARQ study are expected in the US prior to the end of 2011.

The company will be initiating a phase III study of Marqibo in elderly patients with newly diagnosed aggressive Non-Hodgkin's Lymphoma, which will be conducted by the German High-Grade Non-Hodgkin's Lymphoma Study Group, this quarter. (3Q).

The first patient in a phase I trial to evaluate the safety, activity and pharmacokinetics of Marqibo in children and adolescents with relapsed or refractory cancer was enrolled late last month. (July, 2011). The study is being conducted by the Pediatric Branch of the National Cancer Institute.

The other product candidates in Talon's pipeline include Alocrest, a phase I anti-cancer compound for lung and breast cancers, Brakiva, a phase I drug for small cell lung and ovarian cancers and Menadione Topical Lotion for the prevention and treatment of the common, painful, cancer treatment-limiting skin toxicity, which has also completed phase I program.

A quick look at Talon Therapeutics' balance sheet...

The company has no marketed drug and does not generate any revenue from product sales or royalties. Last year, Talon secured financing of up to $100 million from Warburg Pincus and Deerfield Management. As of June 30, 2011, Talon had a stockholder's deficit of roughly $57.1 million, and cash of $10.5 million, which is expected to be sufficient to continue operations through late 2011.

by RTTNews Staff Writer

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