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The first of four Myriad presentations at the meeting was entitled, "Antitumor Activity of MPC-2130 in Human Ovarian and Prostate Tumor Xenografts in Athymic Nude Mice." The presentation described the ability of MPC-2130 to inhibit the growth of blood and solid tumors such as lymphomas, ovarian cancers and prostate cancers, in mouse cancer models. In addition, in vitro studies showed that MPC-2130 was not a substrate for MDR pumps and has significant brain penetration. In preclinical testing, the compound has performed as a broad-acting inducer of apoptosis.
Three additional data presentations are scheduled for today, between 1:00-5:00 pm, and are entitled:
* MPC-6827, a small molecule inhibitor of microtubule formation with high brain penetration: absorption, distribution, metabolism, excretion, and clinical consideration. * MPC-6827: A small molecule inhibitor of microtubule formation that is not a substrate for multi-drug resistance pumps. * MPC-6827, a small molecule inhibitor of microtubule formation: pharmacokinetics in Nu/+ mice and Sprague Dawley rats following intravenous administration
These studies demonstrate that MPC-6827 acts through tubulin; however, unlike other current cancer drugs that effect tubulin, MPC-6827 was equally potent in the induction of apoptosis in cancer cell lines, regardless of the cell line's multiple drug resistance status. These data suggest that MPC-6827 may be effective in the treatment of multiple drug resistant cancers.
In addition to its well-validated cancer drug target and avoidance of MDR, MPC-6827 has the ability to cross the blood/brain barrier and achieve high concentrations in the brain. In preclinical studies, MPC-6827 was demonstrated to reach approximately 1500% greater concentration in the brain than in the blood. The highest brain penetration percentage of drugs that are currently used in treating brain cancer is that of temozolomide, which reaches a peak brain concentration level that is just 29% of the blood plasma concentration. This aspect of the drug candidate suggested an opportunity to study anti-tumor activity in patients with primary brain tumors and brain metastases that are resistant to current standard of care therapy. A Phase 1 study is currently ongoing that is designed to evaluate the potential of MPC-6827 to treat metastatic brain cancer without significant systemic exposure or toxicity.
In preclinical testing, MPC-6827 was demonstrated to be significantly more active than the relevant standard-of-care chemotherapy drug at inhibiting tumor growth in xenograft models of cancer. In these models, MPC-6827 was as effective as doxorubicin in breast cancer, gemcitibine in pancreatic cancer, irinotecan in colon cancer, carboplatin in ovarian cancer and demonstrated a substantial inhibition of prostate cancer tumor growth, for which there is no currently recognized standard of care.
About Multiple Drug Resistance
Cancer cells may become resistant to anti-cancer drugs through a cellular function that actively secretes 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. Both MPC-2130 and MPC-6827 were tested to determine their relative susceptibility to MDR pumps and were shown to be equally effective in anti-cancer activity against both the resistant and non-resistant cell lines tested, demonstrating that the drug candidates are not substrates for MDR pumps.
About Myriad's Clinical Trials in Cancer
Investigational drug MPC-6827 is being studied in two Phase 1 human clinical trials. Both trials use an escalating dose regimen designed to evaluate the safety and pharmacokinetic profile of MPC-6827 in patients with advanced solid tumors. The second Phase 1 trial with this drug candidate focuses on metastatic brain tumors. This more narrowly focused trial is designed to demonstrate the potential seen in preclinical testing with MPC-6827 to treat metastatic brain cancer by achieving therapeutic concentrations in the brain that are sufficient to treat tumors without significant systemic exposure or toxicity.
Also in the Phase 1 clinical trial stage is MPC-2130. The 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 demonstrated significant cancer cell killing activity in ovarian cancer and prostate cancer as well as two lymphoma cell lines, Burkitt's lymphoma and T-cell lymphoma. MPC-2130 was also shown to be effective in mice implanted with human tumors, by demonstrating a significant reduction in ovarian cancer and prostate cancer. In addition, Myriad is evaluating MPC-7869 in a large, well-controlled, 3-year, Phase IIb clinical trial in prostate cancer, which is expected to complete its clinical study period in the second calendar quarter of 2006. Myriad is also developing a broad range of pre-clinical compounds, with three late-stage programs in the fields of cancer, HIV and emesis that have the potential to reach the human clinical trial stage during the next 12 months.
To Review the Presentation Materials
The presentations are published in the 2005 Proceedings of the AACR, and are available online at www.AACR.org or by using the following link: http://www.abstractonline.com/viewer/?mkey=%7B218FF7E7-9F17-4030-9BB4- 8C029B0C9B4E%7D
About Myriad Genetics, Inc.
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. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward looking statements are based on management's current expectation and are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth or implied by forward-looking statements. These include, but are not limited to, uncertainties as to the extent of future government regulation of Myriad Genetics' business; uncertainties as to whether Myriad Genetics and its collaborators will be successful in developing, and obtaining regulatory approval for, and commercial acceptance of, therapeutic compounds; the risk that markets will not exist for therapeutic compounds that Myriad Genetics develops or if such markets exist, that Myriad Genetics will not be able to sell compounds, which it develops, at acceptable prices; and the risk that the Company will not be able to sustain revenue growth for its predictive medicine business and products. These and other risks are identified in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2004. All information in this press release is as of April 18, 2005, and Myriad undertakes no duty to update this information unless required by law.
SOURCE Myriad Genetics, Inc. 04/18/2005 CONTACT: William A. Hockett, Vice President of Corporate Communications of Myriad Genetics, Inc., +1-801-584-3600, bhockett@myriad.comWeb site: http://www.AACR.orgWeb site: http://www.myriad.com