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AstraZeneca Completes Enrollment in Two Pivotal Phase III Studies of the Investigational Drug Vandetanib (ZACTIMA(R)) in Non-Small Cell Lung Cancer (NSCLC)

WILMINGTON, Del., March 12 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) announced today that it has completed patient enrollment in two pivotal Phase III studies for vandetanib, the company's investigational, once-daily oral anti-cancer drug, for the second-line treatment of non-small cell lung cancer (NSCLC). The two studies -- ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer) and ZEAL (ZACTIMA Efficacy with Alimta in Lung cancer) -- are the second and third of four ongoing studies to complete enrollment. Data from the studies are expected later this year and the broad development program is on track for a first regulatory submission in 2008.

ZODIAC is a randomized, double-blind, international, multi-center Phase III study to assess the efficacy of vandetanib 100mg once-daily plus the standard docetaxel chemotherapy versus docetaxel alone in 1,380 patients with locally advanced or metastatic NSCLC after failure of first-line anti-cancer therapy.

ZEAL is a Phase III parallel group, randomized, double-blind study evaluating vandetanib 100mg once daily plus pemetrexed 500mg/m2 (every 3 weeks) compared with placebo plus pemetrexed as second-line treatment in 510 patients with locally advanced or metastatic NSCLC who have failed first-line anti-cancer therapy.

The ZEST study, which is investigating vandetanib versus erlotinib, was the first Phase III study of vandetanib to complete enrollment in November 2007.

"NSCLC is an area of high unmet medical need, and we hope vandetanib will offer a beneficial new treatment option that may improve the lives of people with lung cancer," said Dr. Peter Langmuir, Medical Science Director at AstraZeneca.

ZODIAC and ZEAL are part of a broad Phase III clinical trial program designed to gain an understanding of how vandetanib may benefit people with lung cancer.
The other studies are:

-- ZEST (vandetanib versus erlotinib) enrollment is complete; and

-- ZEPHYR (vandetanib + best supportive care (BSC) versus BSC).

The ZEPHYR study is currently recruiting patients.

The Phase III program in NSCLC follows results from two Phase II trials where vandetanib was studied either alone or in combination with standard chemotherapy (docetaxel).(1)(2) Vandetanib is also being evaluated as a treatment option in medullary thyroid cancer and has been awarded Food and Drug Administration (FDA) orphan drug status and fast track designation for this tumor type.

About vandetanib (ZACTIMA(R))

Vandetanib is an investigational compound being studied as a once-daily oral therapy that fights cancer through two clinically important mechanisms: inhibiting vascular endothelial growth factor receptor 2 (VEGFR2), which blocks the development of tumor blood supply; and inhibiting the epidermal growth factor receptor (EGFR), which may lead to direct inhibition of cancer cell growth and survival.(3)(4) Vandetanib also inhibits RET kinase activity which may be important to the growth and development of certain tumors.(5)

Vandetanib is currently being investigated alone and in combination with chemotherapy treatments to determine its impact in treating a number of solid tumors.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit .

ZACTIMA is a registered trademark of the AstraZeneca group of companies.

(1) Natale RB et al. ZD6474 versus gefitinib in patients with advanced

NSCLC: Final results from two-part, double-blind randomized phase II

trial. Journal of Clinical Oncology, Vol 24, No 18S, 2006: 7000.

(2) Heymach JV et al. Randomized, Placebo-Controlled Phase II Study of

Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung

Cancer. Journal of Clinical Oncology 2007, Vol 25, No 27, 2007:


(3) Wedge, S.R et al. ZD6474 inhibits vascular endothelial growth factor

signaling, angiogenesis, and tumor growth following oral

administration. Cancer Res 2002; 62(16):4645-55.

(4) Holden SN, Eckhardt SG, Basser R et al. Clinical evaluation of ZD6474,

an orally active inhibitor of VEGF and EGF receptor signaling, in

patients with solid, malignant tumors. Ann Oncol 2005; 16(8):


(5) Tada, H, Vasselli, J, Langmuir, P. Clinical Potential of Vandetanib,

an Oral Inhibitor of Key Tumor Signaling Pathways. Proceedings of the

10th International Symposium on Anti-Angiogenesis Agents. Feb. 7-9,


SOURCE AstraZeneca
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