Patients Begin Enrolling in Studies to Determine if Women with BRCA 1 & 2 Positive Cancer May Receive Greater Benefit From New Treatment

2007-06-19 10:17 600

- AstraZeneca Collaborates With Myriad Genetics on Phase 2 Trials

ALDERLEY PARK, England, June 19 /Xinhua-PRNewswire/ -- AstraZeneca (NYSE: AZN) today announced the start of two Phase II trials for a new compound being tested to treat patients with BRCA 1 & 2 positive breast and ovarian cancer. Myriad Genetics, Inc. (Nasdaq: MYGN; ), is providing the molecular diagnostic testing (BRACAnalysis(TM)) for these trials.

The ICEBERG (International Collaborative Expertise for BRCA Education and Research through Genetics) studies are intended to evaluate the ability of AZD2281 (KU-0059436), a PARP (poly-ADP-ribose polymerase) inhibitor, to treat patients with breast cancer or ovarian cancer associated with an inherited mutation in one of the cancer genes, BRCA1 or BRCA2.

The BRCA1 and BRCA2 genes are involved in DNA repair and when this function is lost due to a mutation, cells are unable to repair breaks in DNA. Research has shown that women who inherit faults in either the BRCA1 or BRCA2 genes are predisposed to a higher incidence of breast and ovarian cancer. It is hypothesised that PARP inhibitors work by inhibiting DNA repair in the BRCA deficient tumour cells, thereby overloading these cells with DNA damage and selectively killing these cells. The trials will evaluate the extent of patient response to the treatment and time to disease progression amongst other indicators of clinical benefit.

Lead Investigator for the trials, Dr Andrew Tutt, clinician scientist at the Breakthrough Breast Cancer Research Centre and breast oncologist at Guy's Hospital, London, said: "Having demonstrated the potential of PARP inhibitors through lab work carried out at the Breakthrough Research Centre, we hope these trials will help us confirm the results in the clinic, leading to the development of a targeted treatment for this type of cancer."

Gregory Critchfield, M.D., President of Myriad Genetic Laboratories, Inc. added "There is enormous potential for patient benefit from the synergy between the molecular diagnosis of breast or ovarian cancer and a specific, targeted therapeutic. Myriad's BRACAnalysis(TM) test is a highly sensitive proven method for finding mutations in BRCA1 and BRCA2. The individuals with breast or ovarian cancer who carry these mutations are candidates for the PARP inhibitor therapy approach. It may become more important than ever to know whether a patient with breast or ovarian cancer is BRCA1 or BRCA2 mutation positive."

Study Details

The two studies will enrol up to 40 patients each:

-- Breast study: phase II, open-label, non-comparative, international,

multicentre study to assess the efficacy and safety of AZD2281 given

orally in patients with advanced BRCA1- or BRCA2-associated breast


-- Entry criteria - measurable advanced breast cancer (stage

IIIB/IIIC/IV) and confirmed BRCA+ status.

-- Ovarian study: phase II, open-label, non-comparative, international,

multicentre study to assess the efficacy and safety of AZD2281 given

orally in patients with advanced BRCA1- or BRCA2-associated ovarian


-- Entry criteria - measurable advanced ovarian cancer (stage

IIIB/IIIC/IV) and confirmed BRCA+ status

Notes to Editors:

-- AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of US$26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index. For more information about AstraZeneca, please visit:

-- Breakthrough Breast Cancer is the UK's leading charity committed to fighting breast cancer through research, campaigning and education. Our vision is a future free from the fear of breast cancer. More information can be found at: or through the Breakthrough Information Line 08080-100-200.

-- Breakthrough Breast Cancer has established the UK's first dedicated breast cancer research centre, in partnership with The Institute of Cancer Research, - The Breakthrough Toby Robins Breast Cancer Research Centre situated in the Mary-Jean Mitchell Green Building, Chester Beatty Laboratories, The Institute of Cancer Research. Under the directorship of Professor Alan Ashworth, its 100 scientists and clinicians are working on a programme of cutting edge biological research that ultimately aims to eradicate breast cancer, by discovering the causes of the disease, finding methods of prevention and developing new treatments and more effective diagnosis.

-- BRACAnalysis(TM) is a trademark of Myriad Genetics, Inc. in the United States and other countries.

-- Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at

-- KuDOS Pharmaceuticals Ltd is a wholly-owned subsidiary of AstraZeneca. AZ acquired KuDOS Pharmaceuticals in Feb 2006. KuDOS research is focused on the discovery of molecules to treat cancer in the area of DNA repair inhibition.

-- KuDOS Pharmaceuticals will run the international, multi-center clinical trial and reimburse Myriad for provision of the molecular diagnostic testing for the trial. Myriad will have exclusive worldwide rights to diagnostic applications of the findings from the study and KuDOS, all rights to its therapeutic and its applications.

Source: AstraZeneca