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Hana Biosciences Initiates Phase I Clinical Trial of a Targeted Chemotherapy Agent for Patients With Advanced Solid Tumors.


SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif. -- Hana Biosciences (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:HNAB), a biopharmaceutical company focused on advancing cancer care, today announced the initiation of a Phase I clinical study of Sphingosome Encapsulated Vinorelbine in patients with advanced solid tumors.

This Phase I study is designed to assess the safety, tolerability and preliminary efficacy of Sphingosome Encapsulated Vinorelbine in patients with advanced solid tumors. Hana is developing this compound for patients with non-small cell lung cancer Lung Cancer, Non-Small Cell Definition

Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors.
Description

There are two kinds of lung cancers, primary and secondary.
 and breast cancer, among others. The study is being conducted at the Cancer Therapy and Research Center, San Antonio and McGill University, Montreal.

"This trial affirms Hana Biosciences' commitment to the continued advancement of promising product candidates with the potential to improve patient care," said Gregory Berk, M.D, Senior Vice President and Chief Medical Officer. "We believe this novel product may allow for improved delivery and pharmaceutical attributes of vinorelbine, a well-established therapy for lung and breast cancer.

About Vinorelbine and Sphingosomal Targeted Drug Delivery Scientists began to study targeted drug delivery, because the traditional drug delivery system had many disadvantages, such as high toxic effect and high minimum effective dose. In traditional drug delivery system, after the patient takes some drugs, the drugs will be all over his body  

Vinorelbine, a semi-synthetic vinca alkaloid, is a microtubule microtubule

Tubular structure enclosed by a membrane found within animal and plant cells. Of varying length, they have several functions. They help give shape to many cells and are major components of cilia and flagella, participate in the formation of the spindle during
 inhibitor that has been approved for use as a single agent or in combination with cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic.

cis·plat·in
n.
 for the first-line treatment of advanced non-small cell lung cancer. Vinorelbine is also widely used for the treatment of breast cancer.

Sphingosomal encapsulation is a targeted liposomal drug delivery platform, which is designed to significantly increase tumor targeting and duration of exposure for cell cycle-specific anticancer agents. Encapsulation also allows an increase in dose intensity without increased toxicity, in preclinical studies. Vincristine vincristine /vin·cris·tine/ (vin-kris´ten) an antineoplastic vinca alkaloid; used as the sulfate salt in the treatment of various neoplasms, including Hodgkin's disease, acute lymphocytic leukemia, non-Hodgkin's lymphoma, Kaposi's , vinorelbine and topotecan are approved cancer therapies which have been selected for sphingosomal formulation specifically for their ability to benefit from this novel encapsulation.

The possible advantages of sphingosomal drug delivery include:

--Longer circulation time in plasma delivers more of the therapeutic agent to targeted tumor sites over a longer period of time. To stabilize the lipid bilayer walls and retain active drug within the aqueous interior, this new generation liposomal technology uses sphingomyelin sphingomyelin /sphin·go·my·elin/ (-mi´e-lin) any of the sphingolipids in which the head group is phosphorylated choline; they occur in membranes, primarily in nervous tissue, and accumulate abnormally in Niemann-Pick disease. , a safe, biologically inert macromolecule macromolecule, term that may refer either to a crystal such as a diamond, in which the atoms are identical and held by covalent bonds (see chemical bond) of equal strength, or to one of the units that compose a polymer.  whose amide backbone is resistant to hydrolysis hydrolysis (hīdrŏl`ĭsĭs), chemical reaction of a compound with water, usually resulting in the formation of one or more new compounds. . The increased rigidity of the liposomal walls prolongs the circulating life of liposomes Liposomes

Aqueous compartments enclosed by lipid bilayer membranes; liposomes are also known as lipid vesicles. Phospholipid molecules consist of an elongated nonpolar (hydrophobic) structure with a polar (hydrophilic) structure at one end.
 and significantly extends the duration of drug release.

--Slow release of the drug from extravasated sphingosomes increases drug levels within the tumor, extends drug exposure through multiple cell cycles, and significantly enhances tumor cell killing. The immature neovasculature within tumors is created during angiogenesis and has numerous imperfections, pores and discontinuities up to 800 nm in size. With an average diameter of approximately 100 nm, sphingosomes readily extravasate ex·trav·a·sate
v.
To exude from or pass out of a vessel into the tissues. Used of blood, lymph, or urine.



ex·trav
 through these pores and accumulate within the tumor and slowly release the encapsulated drug.

--Increased drug concentration at the tumor site is believed to be associated with increased clinical activity. The link between drug exposure and anti-tumor efficacy is especially pronounced for cell cycle-specific agents such as vincristine, vinorelbine and topotecan, which kill tumor cells by interfering with mitosis at a precise step during the cancer cell cycle. This proprietary sphingosomal drug delivery platform is designed to encapsulate these agents within the aqueous interior of small liposomes in order to enhance the therapeutic index of these existing anticancer treatments.

This sphingosome encapsulated technology was discovered at the University of British Columbia Locations
Vancouver
The Vancouver campus is located at Point Grey, a twenty-minute drive from downtown Vancouver. It is near several beaches and has views of the North Shore mountains. The 7.
 and subsequently developed by Inex Pharmaceuticals Corporation. In May 2006, Hana Biosciences licensed three drug candidates utilizing this technology from Inex.

About Non-Small Cell Lung Cancer (NSCLC NSCLC non (or cancer).
NSCLC Non-small cell lung cancer, see there
)

According to the World Health Organization, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths annually. It is estimated that more than 173,000 people will be diagnosed with lung cancer in the United States in 2005. According to the National Cancer Institute, lung cancer is the single largest cause of cancer deaths in the United States and is responsible for nearly 30 percent of cancer deaths in this country. NSCLC accounts for more than 80 percent of all lung cancers. Despite recent therapeutic advances in NSCLC, the overall survival remains poor and there is a need for improved treatments.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (NASDAQ:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to advance cancer care. The company is committed to creating value by building a world-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.

About Inex Pharmaceuticals Corporation

Inex Pharmaceuticals Corporation is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Since 1996, INEX common shares have been trading on the Toronto Stock Exchange Toronto Stock Exchange (TSE)

Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options.
 under the symbol "IEX IEX Ion Exchange (chromatography)
IEX Inter-Exchange Carrier
". Additional information on Inex Pharmaceuticals can be found at www.inexpharm.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's development efforts relating to its product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Hana's product candidates, the risk that the results of clinical trials may not support Hana's claims, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Quarterly Report on Form 10-Q for the three months ended March 31, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Aug 3, 2006
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