SAN FRANCISCO, Dec. 17 Medivation, Inc.(Nasdaq: MDVN) today announced that it has completed patient enrollment in aPhase 1-2 dose-escalation clinical trial of MDV3100, its novel androgenreceptor antagonist, in castration-resistant prostate cancer patients, andthat it will seek approval from the U.S. Food and Drug Administration (FDA) toadvance to Phase 3 clinical trials next year.
The open-label, U.S. Phase 1-2 study evaluated prostate cancer patientswho had failed standard hormonal therapies, including men who had also failedstandard chemotherapy regimens. A total of 140 men were enrolled in the trial,which evaluated doses between 30 and 600 mg/day. Patients are being followedand may remain on treatment for as long as they continue to tolerate the drugand their disease does not progress.
Preliminary results of this trial, covering 73 treated patients in the 60,150 and 240 mg/day dose groups, were presented in October at the 20thEORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Thedata showed encouraging and durable anti-tumor activity as measured byprostate specific antigen (PSA) declines, radiographic findings, circulatingtumor cell (CTC) changes and time on treatment. These data also suggested adose-response trend, with a higher percentage of patients in the 240 mg/daydose group experiencing 90 percent reduction in PSA levels, radiographicpartial responses and conversions to favorable CTC counts of less than fivepost-treatment.
The Company expects to move into Phase 3 trials with either the 240 or the360 mg/day dose, both of which have been generally well tolerated. The 480mg/day dose did not have acceptable tolerability due to side effects,primarily fatigue. Efficacy data from the 360 mg/day dose group are underanalysis and will be presented at an upcoming medical meeting, along withadditional efficacy data from the 240 mg/day and lower dose groups. Finalselection of the Phase 3 dose will be made following completion of dataanalyses.
"We are pleased to have reached another development milestone in ourprostate cancer program by successfully completing enrollment in our Phase 1-2clinical trial in castration-resistant prostate cancer patients with limitedtreatment options," said Lynn Seely, M.D., chief medical officer ofMedivation. "We look forward to presenting additional data from this trialand to advancing this program into Phase 3 development in 2009, as we havepreviously guided."
About Prostate Cancer and MDV3100
Prostate cancer is the most common non-skin cancer in the United Statesand the third most common cancer worldwide. More than 1 million men in theUnited States have prostate cancer. An estimated 186,320 new cases areexpected to be diagnosed in 2008, and approximately 28,660 men are expected todie this year from the disease. Patients with castration-resistant (also knownas hormone-refractory) prostate cancer have few treatment options and a poorprognosis.
Overexpression of the androgen receptor is believed to contribute to theprogression of castration-resistant prostate cancer. MDV3100 is a novelsmall-molecule androgen receptor antagonist that inhibits androgen receptorfunction by blocking nuclear translocation of the androgen receptor and DNAbinding.
Medivation, Inc. is a biopharmaceutical company focused on the rapiddevelopment of novel small molecule drugs to treat serious diseases for whichthere are limited treatment options. Medivation aims to transform thetreatment of these diseases and offer hope to critically ill patients andtheir caregivers. In September 2008, Medivation entered into a globalagreement with Pfizer Inc to develop and commercialize Dimebon for thetreatment of Alzheimer's and Huntington's diseases. With Pfizer, the Companyis conducting a broad Dimebon clinical development program, including apivotal and confirmatory Phase 3 trial, known as the CONNECTION study, inpatients with mild-to-moderate Alzheimer's disease. The program also includesadditional trials planned to begin next year in Alzheimer's disease, as wellas further development of Dimebon in patients with mild-to-moderateHuntington's disease. In addition, a Phase 1-2 clinical trial of MDV3100 inpatients with castration-resistant (also known as hormone-refractory) prostatecancer is ongoing. For more information, please visit us athttp://www.medivation.com.
This press release contains forward-looking statements, includingstatements regarding the timing and expected dosing regimen of Phase 3 trialsof MDV3100, which are made pursuant to the safe harbor provisions of thePrivate Securities Litigation Reform Act of 1995. Any statements contained inthis press release that are not statements of historical fact may be deemed tobe forward-looking statements. Forward-looking statements involve risks anduncertainties that could cause Medivation's actual results to differsignificantly from those projected, including, without limitation, risksrelated to progress, timing and results of Medivation's clinical trials,difficulties or delays in obtaining regulatory approval, enrollment ofpatients in Medivation's clinical trials, partnering of Medivation's productcandidates, including Medivation's collaborative relationship with Pfizer,manufacturing of Medivation's product candidates, competition withMedivation's product candidates should they receive marketing approval, theadequacy of Medivation's financial resources, unanticipated expenditures orliabilities, intellectual property matters, and other risks detailed inMedivation's filings with the Securities and Exchange Commission, includingits quarterly report on Form 10-Q filed on November 10, 2008, with the SEC.You are cautioned not to place undue reliance on the forward-lookingstatements, which speak only as of the date of this release. Medivationdisclaims any obligation or undertaking to update or revise anyforward-looking statements contained in this press release.
SOURCE Medivation, Inc.