By Brady Huggett
EntreMed Inc., giving its anticancer product 2ME2 the new name of Panzem, began Phase II trials in prostate cancer for the product, bringing to 12 the total number of trials for its Panzem, Endostatin and Angiostatin products.
Panzem also is in two Phase I trials for breast cancer and one Phase II for patients with multiple myeloma. The Phase II trial in prostate cancer will be split into two sites - Indiana University and the University of Wisconsin - with a total of 32 patients to be enrolled.
"We are totally committed to bringing some of these molecules to patients and adding options to patients with cancer, who have very few at the moment," said Joanna Horobin, executive vice president for commercial development at EntreMed, commenting on the 12 trials. "We have more angiogenesis inhibitors in human clinical trials in oncology than any other company that I am aware of, including the largest ones."
The study, said Horobin, should be fully recruited in six to nine months and completed in about a year, though she mentioned the difficulty in predicting the nature of such things. However, the two locations for the study should improve the timeline and help with recruiting, she said.
EntreMed, of Rockville, Md., registered for a potential $42 million public offering last week, and while the money won't be used entirely for these trials, most of it will, Horobin said. (See BioWorld Today, Feb. 7, 2001.)
Being orally available is an important aspect of Panzem, said Mary Sundeen, senior director, corporate communications at EntreMed.
"It's patient-friendly," she said. "They can carry it around with them, go to the movies, whatever, they can go on with their life."
Panzem (2-methoxyestradiol) is anti-proliferative, meaning it is designed to stop tumor cells from growing as well as to restrict new blood vessel growth, thus having a double effect on cancer. And, like many products working their way through trials, the product earned a new moniker.
"We looked at a lot of names," Horobin said. "We chose Pan, meaning 'all,' because it affects a lot of different cells. And zem, if you look at it in the mirror, looks like ME2. It's a pretty strong name and people are interested in getting strong products for cancer. It tested well all over the world."
Sundeen said EntreMed is working on an injectable form of Endostatin. It is examining a continuous infusion pump against a subcutaneous injection in European trials, although patients that have been on the protocol for intravenous administration may be able to access the continuous infusion pump in the United States at the Dana-Farber Cancer Institute in Boston.
Horobin said Endostatin has completed the first stage of Phase I, but classified Angiostatin as "a little further behind," saying recruitment of the first Phase I trials is not yet complete.
"The programs are moving absolutely on schedule," she said.
"Our philosophy is we initiate in the U.S. and then find a way to take the molecules into Europe, and then maybe into Japan," Horobin said. "That way, once the molecules do get approved, we can launch in many countries and won't miss a heartbeat."
EntreMed's stock (NASDAQ:ENMD) rose 31.25 cents Thursday to close at $20.625. n