Myriad Genetics, Inc. has submitted an Investigational New Drug (IND) application to the FDA to begin a phase I clinical study with its pro-apoptotic cancer drug candidate, MPC-6827.

The study is designed to evaluate the safety and pharmacokinetic profile of MPC-6827 in patients with advanced solid tumours, in an escalating dose regimen. In preclinical testing, MPC-6827 has been equally active against multiple drug resistant cancers as with susceptible tumours, unlike many of the current options in cancer chemotherapy, a limitation that represents a significant unmet medical need, the company claims here.

"MPC-6827 has demonstrated the ability to inhibit tumour growth in preclinical testing, with activity in animal models of human melanoma and cancers of the ovary, breast, prostate, colon and pancreas," said Adrian Hobden, president of Myriad Pharmaceuticals, Inc. "This IND submission is a major milestone in the development of this new drug candidate, and we are excited about the possibility of demonstrating the same activity in cancer patients that we have found in preclinical testing with MPC-6827," he added.

In preclinical testing, MPC-6827 was demonstrated to be significantly more active than the relevant standard-of-care chemotherapy drug at inhibiting tumour growth in xenograft models of cancer. MPC-6827 was shown to be more effective than doxorubicin in breast cancer, gemcitibine in pancreatic cancer, irinotecan in colon cancer, carboplatin in ovarian cancer and demonstrated a substantial inhibition of prostate cancer tumour growth, for which there is no currently recognized standard of care.

"MPC-6827 is Myriad's third clinical drug development program and we are on schedule to move a fourth program into the clinic in the very near future," said Peter Meldrum, President and Chief Executive Officer of Myriad Genetics, Inc. "Our drug candidates address Alzheimer's disease and multiple types of cancer, all diseases for which we believe there is significant unmet medical need and very large potential markets."

Cancer cells may become resistant to chemotherapy through a cellular function that actively excretes drug from the cell. The function is carried out by multiple drug resistance (MDR) pumps and is the primary cause of cancer's resistance to marketed drugs such as paclitaxel and vinblastine. MPC-6827 was tested, in parallel with vinblastine and docetaxel, to determine its relative susceptibility to MDR pumps. MPC-6827 was shown to be equally effective in anti-cancer activity against the MDR cell lines tested, suggesting that the drug candidate is not a substrate for MDR pumps.
In contrast, the potency of the currently marketed drugs was substantially reduced against these MDR cell lines, requiring approximately 20 to 70 times more drug in the case of docetaxel and 165 to 1,200 times more drug for vinblastine, to reach the same level of activity that was measured in non-MDR cells, the release says.

MPC-6827 was identified by Myriad researchers from a family of compounds acquired from Maxim Pharmaceuticals, Inc. All chemistry, lead optimization and preclinical development on the compound were performed by Myriad or for Myriad under its direction.

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.