, Aug 29, 2012
/PRNewswire/ -- Proacta Incorporated announced today that the US Food and Drug Administration has allowed its Investigational New Drug (IND) Application for PR610, a hypoxia-activated, irreversible multi-kinase inhibitor (MKI) for the treatment of cancer.
The IND allowance permits Proacta to initiate human clinical trials of this novel, first in class treatment. Initially, development will focus on patients with non-small cell lung cancer who have developed resistance to reversible tyrosine kinase inhibitors such as erlotinib and /or gefitinib. In such cases, no effective treatment is currently available.
The first clinical study will be conducted at sites in the US and New Zealand. Proacta expects to initiate patient enrollment in the coming weeks.
PR610 is Proacta's proprietary hypoxia-activated irreversible MKI discovered at the Auckland Cancer Society Research Centre, University of Auckland, New Zealand. Reversible MKI's are currently used for the treatment of several types of cancer. However, resistance often develops to reversible MKI's and side effects limit their use at higher doses.
PR610 utilizes an irreversible MKI that is activated in areas of severe hypoxia, a characteristic of most solid tumors. Localized release of the irreversible MKI within tumors leads to higher tumor concentrations and lower concentrations in normal tissues, which should result in improved efficacy and fewer side effects. In addition, irreversible MKI inhibitors are not affected by some of the resistance mechanisms that limit use of reversible MKI inhibitors.
In subsequent studies, Proacta expects to evaluate PR610 in other cancers that are currently treated with first-generation reversible tyrosine kinase inhibitors such as gastric, breast, and pancreatic.
In 2011, Proacta engaged in the collaboration for research, development and commercialization of PR610 in Japan with Yakult Honsha Co., Ltd. whose pharmaceutical business is focused on oncology.
About Proacta Incorporated
Proacta is a San Diego based biotechnology company dedicated to the development and commercialization of hypoxia-activated oncology drugs. Proacta has a pipeline of hypoxia-activated prodrugs for the treatment of cancer that are licensed from the University of Auckland in New Zealand. For more information, visit the Proacta web site at www.proacta.com.