Children’s Oncology Drug Alliance (CODA) Formed for Childhood Cancers
SYDNEY and COLUMBUS, OH, May 4, 2014 – Researchers and children’s cancer advocates in Australia and the U.S. have formed a unique research and development alliance to facilitate development of treatments for children fighting neuroblastoma, the most common and fatal form of solid cancer affecting infants.
“For too long, childhood cancers have been neglected despite the progress made with treatments for adult cancers. The Alliance brings together the science, expertise and funding to accelerate the development of a medicine that has the potential to change the way we treat solid cancers in children,”said Professor Peter Gunning, Head of the Oncology Research Unit at UNSW Medicine.
Currently there is no medicine approved to treat neuroblastoma, a cancer that affects up to 100 children in Australia and around 650 in the United States each year. Childhood cancers such as neuroblastoma currently are treated with chemotherapies that have been developed for adults with little consideration to the special needs of children.
CODA plans to work with U.S. and Australian regulators to launch and advance clinical trials of a unique new anti-cancer approach originally discovered and investigated by Professor Gunning’s UNSW research team and funded by The Kids’ Cancer Project. Now being taken forward commercially by Novogen, the drug, which belongs to a class of therapies known as anti-tropomyosins, has been specifically tailored to selectively target the structure of the cancer cell, causing it to collapse without adversely impacting healthy cells.
“These drugs are very promising and long overdue,” said Professor Peter Smith, M.D., Dean of UNSW Medicine, who has worked as a childhood oncologist and is a member of The Kids’ Cancer Project’s Research Advisory Committee.“Based on evidence seen in pre-clinical models, the anti-tropomyosins appear to have the potential to become the most significant development in the treatment of childhood cancer in more than 20 years.”
“Our research has shown anti-tropomyosins to be highly effective at killing neuroblastoma cells and slowing their growth in animal models,”said Professor Timothy Cripe, M.D., Chief of Pediatric Hematology/Oncology/Blood and Marrow Transplantation at the Nationwide Children’s Hospital. Affiliated with The Ohio State University, Nationwide Children’s Hospital is one of the top hospitals in the U.S. for treating children with neuroblastoma.
“The Holy Grail of childhood cancer therapy is a medicine that is effective against the cancer, but doesn’t leave the sort of damage that the child then has to deal with for the rest of his or her life,”Novogen CEO, Dr. Graham Kelly, said.“We believe the drugs we have developed have the potency, selectivity and safety profile to meet the special needs of children,” he said.
“We intend to make both our anti-tropomyosin and super-benzopyran drug technologies available for this cause,”Kelly added.
Novogen currently is finalizing pre-clinical research of its two lead dug candidates, with the goal of starting clinical studies in Australian and U.S. patients in 2015. The aim is that the childhood trials in neuroblastoma will be progressed in parallel with trials of anti-tropomyosins and super-benzopyrans for a number of adult cancers.
Novogen acquired the anti-tropomyosin technology from another Australian biotechnology company in 2013 and has used its drug discovery expertise to produce molecules substantially more potent in the lab than those originally developed.
The Kids’ Cancer Project has supported the anti-tropomyosin research program since its beginnings in 1998, providing funding of $9 million to date. The charity also aims to raise a further $2.7 million to support clinical trials of the new medicine in children with neuroblastoma who have exhausted other treatment options.
Col Reynolds OAM, Founder of The Kids’ Cancer Project, said:“Thanks to the generosity of our donors, we have been able to fund the initial research and proof-of-concept studies. The Alliance with Novogen and the other CODA partners now provides the means to progress to the clinical trial phase.”
Mr. Reynolds said The Kids’ Cancer Project would continue to fundraise to ensure that the next phase of research into a treatment for neuroblastoma was not delayed. He highlighted that childhood cancers are second only to breast cancer in terms of the number of years of life lost to cancer in Australia.“The Alliance would like to see other groups join the cause. We are keen to partner with anyone who can contribute to the development of improved treatment options for children with cancer,”he said.
The clinical trials due to start in the U.S. and Australia next year are the first important step towards this treatment becoming available to patients on a general basis; the process of which is expected to take a number of years.
Donations to The Kids’ Cancer Project can be made at www.thekidscancerproject.org.au.
Notes To Editors
Neuroblastoma is a cancer that develops from immature nerve cells found in several areas of the body. Neuroblastoma most commonly arises in and around the adrenal glands, which have similar origins to nerve cells and sit atop the kidneys. However, neuroblastoma can also develop in other areas of the abdomen and in the chest, neck and near the spine, where groups of nerve cells exist. Neuroblastoma most commonly affects children age 5 or younger, though it may rarely occur in older children. Some forms of neuroblastoma go away on their own, while others may require multiple treatments.
About The Kids Cancer Project
The Kids’ Cancer Project is an Australian charity focused on finding cures for childhood cancer. Their aim is to fund research programs dedicated to finding cures for childhood cancer. Ultimately, finding a cure is about saving children’s lives and ending the heartbreak childhood cancer brings to so many families. Currently The Kids’ Cancer Project is focused on finding cures for brain tumours and neuroblastoma.
About the University of New South Wales Australia
UNSW Australia is one of the country’s leading research and teaching universities. Established in 1949, it is ranked among the top 60 universities in the world, renowned for the quality of its graduates and its world-class research. UNSW is a founding member of the Group of Eight, a coalition of Australia’s leading research-intensive universities, and of the prestigious international network Universitas 21. With more than 50,000 students from over 120 countries, it is one of Australia’s most cosmopolitan universities.
About NewSouth Innovations
NewSouth Innovations is the gateway to research discoveries and inventions created at UNSW Australia. (The University of New South Wales). NSi focuses on transforming research discoveries into successful innovations and products to benefit society, the economy and future generations.
About Nationwide Children’s Hospital
Ranked in all 10 specialties on U.S.News & World Report’s 2013-14 “America’s Best Children’s Hospitals” list and among the Top 10 on Parents magazine’s 2013 “Best Children’s Hospitals” list, Nationwide Children’s Hospital is one of the nation’s largest not-for-profit freestanding pediatric healthcare networks providing care for infants, children and adolescents as well as adult patients with congenital disease. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s faculty train the next generation of pediatricians, scientists and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities in the U.S., supporting basic, clinical, translational and health services research at Nationwide Children’s. The Research Institute encompasses three research facilities totaling 525,000 square feet dedicated to research. More information is available at www.NationwideChildrens.org/Research.
Novogen is a public, Australian biotechnology company whose shares trade on both the Australian Securities Exchange (‘NRT’) and NASDAQ (‘NVGN’). The Company is based in Sydney, Australia, and with a U.S. office in New Haven, Connecticut. The Company has two main drug technology platforms known as super-benzopyrans (SBP) and anti-tropomyosins (ATM). SBP drugs target cancer stem cells and are being developed for the treatment of ovarian cancer and glioblastoma. ATM drugs target the cancer cell cytoskeleton and are being developed for the treatment of melanoma, prostate cancer, ovarian cancer and neuroblastoma. Novogen has entered into a joint venture with Yale University known as CanTx Inc. with the aim of developing an intra-peritoneal product for late-stage ovarian cancer.
Further information on CODA is available at www.childrensoncologydrugalliance.org
Further information on Novogen is available on the Company’s website, www.novogen.com.