Azaya Therapeutics Receives FDA Authorization To Start Phase I Cancer Trial

Azaya Therapeutics, Inc. announced that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its lead product “ATI-1123,” a novel and improved formulation of Taxotere® (docetaxel), a leading chemotherapy drug with worldwide annual sales of over $2.8 billion.

Azaya’s Phase I clinical study will now open for enrollment at two premier cancer research centers in Texas: South Texas Accelerated Research Therapeutics at the START Center for Cancer Care in San Antonio and The Mary Crowley Cancer Research Center in Dallas. Patients with solid tumors that have not responded to treatment with other anti-cancer agents will be enrolled in the study. The study is designed as an open-label, dose-escalation study that will determine the safety, tolerability and pharmacokinetics of the drug. The study also provides for the collection of efficacy data.

“The FDA’s acceptance of our IND package is an important milestone in the commercialization of this important and innovative new cancer treatment,” said Michael T. Dwyer, president and CEO of Azaya. “Developing a cancer treatment such as ours takes an extraordinary amount of time and effort, and I am pleased to initiate our Phase I trial for patient enrollment,” he added. Read more

FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma

The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts.

Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin’s lymphoma. It is a slow growing cancer that affects lymphocytes, a type of white blood cell that helps the body fight infection.

The cancer usually starts with dry skin and a red rash, and then itching that can be very severe and the skin can develop tumors that become ulcerated and then infected. In some cases the cancer spreads to the blood, lymph nodes and internal organs.

If a patient has localized CTCL they can be treated with topical agents such as special skin creams or with phototherapy, but if the cancer spreads then they usually need chemotherapy. Read more

FDA Approved Leukemia Drug Shows Promising Activity In Ovarian Cancer Cells

The drug Sprycel, approved for use by the U.S. Food and Drug Administration in patients with chronic myeloid leukemia, significantly inhibited the growth and invasiveness of ovarian cancer cells and also promoted their death, a study by researchers with UCLA’s Jonsson Comprehensive Cancer Center found.

The drug, when paired with a chemotherapy regimen, was even more effective in fighting ovarian cancer in cell lines in which signaling of the Src family kinases, associated with the deadly disease, is activated.

The study appears in the Nov. 10, 2009 edition of the British Medical Journal.

Ovarian cancer, which will strike 21,600 women this year and kill 15,500, causes more deaths than any other cancer of the female reproductive system. Few effective therapies for ovarian cancer exist, so it would be advantageous for patients if a new drug could be found that fights the cancer, said Gottfried Konecny, an assistant professor of hematology/oncology, a Jonsson Cancer Center researcher and first author of the study. Read more