Myriad Genetics Submits IND on Cancer Drug Candidate
[With the interest level in cancer and CNS diseases on this board, I’m surprised there hasn’t been more discussion of MYGN. Does anyone here own them?]
>> - Company's Third Cancer Program to Begin a Phase I Clinical Trial -
SALT LAKE CITY, Dec. 28 /PRNewswire-FirstCall/ -- Myriad Genetics, Inc. (Nasdaq: MYGN), announced today that it has submitted an Investigational New Drug (IND) application to the FDA to begin a Phase I human clinical trial with MPC-2130 (previously referred to as MPI-176716), a broad-acting inducer of apoptosis in cancer cells.
The Phase I clinical study is designed to evaluate the safety and pharmacokinetic profile of MPC-2130 in patients with advanced metastatic tumors or blood cancers as well as refractory cancer that has progressed despite previous chemotherapy. In preclinical studies MPC-2130 has demonstrated significant cancer cell killing activity in ovarian cancer, prostate cancer and two lymphoma cell lines, Burkitt's lymphoma and T-cell lymphoma. MPC-2130 was also evaluated in xenograft mouse models of ovarian cancer and prostate cancer. The drug candidate reduced growth of ovarian cancer tumors by 61% relative to controls. MPC-2130 was also effective in demonstrating a significant reduction in tumor volumes in mice implanted with human prostate cancer.
"MPC-2130 is our second investigational drug for cancer to enter the clinic using the apoptotic pathway and fighting cellular proliferation by causing cancer cells to self-destruct. However, our two cancer compounds are very different and function at independent points in the apoptosis pathway," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "Not only does each compound demonstrate preclinical attributes that provide it with potentially broad utility in metastatic cancer, but the two drug candidates also display their best potencies against different cancer types."
Multiple Drug Resistance
Importantly, MPC-2130 was shown to be highly effective in cancer cell lines that are resistant to multiple drugs. Cancer cells may become resistant to chemotherapy through a cellular function that actively purges drug from the cell. The function is carried out by MDR pumps and is the primary cause of cancers' resistance to many marketed drugs such as paclitaxel and vinblastine. MPC-2130 was tested to determine its susceptibility to MDR pumps, and 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.
Myriad's Clinical Drug Development Programs
* FLURIZAN(TM) (R-flurbiprofen) is Myriad's investigative drug for Alzheimer's. This drug candidate is being investigated in a large, well-controlled Phase 2 trial in Alzheimer's disease that is expected to complete its study period in the first quarter of calendar 2005.
* FLURIZAN is also under study in a large, well-controlled, 3-year, Phase 2b clinical trial in prostate cancer. This study is expected to complete in second quarter of calendar 2006.
* MPC-6827 was Myriad's first apoptosis-inducing cancer drug candidate. The IND was submitted to the FDA in December 2004. The Phase 1 study is a dose escalating clinical trial in cancer patients with solid tumors.
* MPC-2130 is the Company's second cancer IND submitted to the FDA this month. The Phase 1 study will evaluate the safety of the drug candidate in cancer patients with both solid tumors and blood cancers.
* Myriad is developing a broad range of development stage compounds toward human clinical trials, with two late-stage programs that may reach the clinic over the next 12 months, in the fields of HIV and CINV (chemotherapy-induced nausea and vomiting). <<
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