Thanks, Baird. Guess it's a gamble on whether upping the dose will jack up the efficacy enough to get approval.
I'm not too concerned about market size, but it looks to me like they may just be rolling the dice on efficacy here.
Note that even if they are successful, there is a potential competitor ahead of them:
DATA SAFETY MONITORING BOARD APPROVES PROGRESSION OF THYMITAQ® PHASE III ETHECC TRIAL IN LIVER CANCER
BERWYN, PA, January 13, 2003 ? EXIMIAS Pharmaceutical Corporation announced the independent Data Safety Monitoring Board (DSMB) unanimously recommended the continuation of the Phase III ETHECC trial (Evaluation of THYMITAQ® in Hepatocellular Cancer). The anticancer agent THYMITAQ® is the only drug with clinical data showing a survival advantage in liver cancer.
The DSMB interim review of safety data was successfully completed in over 140 patients from the ongoing global trial. ?The DSMB stated that the ETHECC trial can continue without modifications since the safety profile is acceptable and no safety concerns have been identified?, said Dr. José Garcia-Vargas, EXIMIAS? Vice President, Clinical Development. Data Safety Monitoring Boards are comprised of independent oncologists and statisticians responsible for evaluating patient safety and ensuring the integrity of trials.
The pivotal Phase III ETHECC trial is underway at nearly 70 sites in the US, Canada, Europe and South Africa. THYMITAQ® is the only drug currently in a full phase III program for the treatment of liver Cancer. The trial, designed to show increased survival in patients with primary liver cancer, is planned to complete enrollment by the end of 2003.
?We are pleased with the decision of the DSMB to continue the progress with the ETHECC trial without any hesitations. Having reached the 50% accrual mark in 2002, our planned NDA submission is on track for the second half of 2004?, said Dr. Elizabeth Corsi, President and CEO.
About THYMITAQ®
THYMITAQ® is a novel, potent direct thymidylate synthase (TS) inhibitor with broad spectrum anticancer activity in solid tumors. The FDA has designated THYMITAQ® as a Fast Track product and the program has also received Orphan Drug Status. There are over a million cases of liver cancer worldwide and many patients are untreated because there is no treatment approved for liver cancer.
About EXIMIAS Pharmaceutical Corporation
EXIMIAS Pharmaceutical Corporation is a specialty pharmaceutical company that develops, markets and sells unique prescription products in oncology and hospital based markets. The company has two novel pharmaceutical clinical stage products, THYMITAQ® a unique anticancer and lanimostim, for serious fungal infections. Our strategy is to acquire additional products which can generate revenues and establish a commercial infrastructure to leverage our pipeline products from a sales and marketing perspective.
Never previously heard of this drug or Eximias - they are privately held:
eximiaspharm.com
TLRK does look real tempting at these prices, though.
Peter |
