February 04, 2005

IN BRIEF: LIGAND PHARMACEUTICALS INC.

Ligand Pharmaceuticals Inc. confirmed that Pfizer Inc. submitted a supplemental New Drug Application to the Food and Drug Administration in December to use Ligand's selective estrogen receptor modulator, lasofoxifene, for the treatment of vaginal atrophy. In August 2004, Pfizer filed an NDA for lasofoxifene to be used in the prevention of osteoporosis. The pharmaceutical brand is the first of Ligand's royalty-bearing products to reach the NDA submission stage.

Thursday, January 27, 2005

IN BRIEF: GTX INC.

GTx Inc. began a Phase III trial of its nonsteroidal selective estrogen receptor modulator Acapodene (toremifene citrate) for the prevention of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia, a precancerous lesion in prostate cancer. For the double-blind study, patients will be randomized to 20 mg of Acapodene or placebo. The primary endpoint is the incidence of prostate cancer.

Monday, July 19, 2004

ACAPODENE MAY PREVENT PROGRESSION TO PROSTATE CANCER AMONG PATIENTS WITH PIN, NEW STUDY SHOWS

The investigational prostate cancer drug Acapodene (toremifene citrate) appears to reduce the incidence of prostate cancer in high-risk men, according to GTx Inc. The company has licensed worldwide rights to develop, market and distribute toremifene citrate from Orion Corp. for the prevention and treatment of prostate cancer.

GTx's Phase IIb trial compared Acapodene with placebo among 514 male patients with high-grade prostatic intraepithelial neoplasia (PIN), a premalignant lesion that has the strong possibility of progressing to prostate cancer.

At one year, there was a significant reduction in prostate cancer cumulative risk in the Acapoden 20 mg arm: 24.4 percent versus 31.2 percent in the placebo group. Furthermore, patients with a negative prostate cancer biopsy after six months of treatment showed a 48 percent risk-reduction after a full year of treatment.

Compared with men who developed prostate cancer while receiving placebo, those who developed prostate cancer while receiving Acapodene exhibited no significant difference in tumor grade, but showed a trend toward lower grade. Serious adverse events were also comparable between placebo and Acapodene.

These data were presented in Memphis, Tenn., at the 4th International Prostate Cancer Congress.

"[T]his study puts to rest the controversy about high grade PIN--high grade PIN patients are at high risk for prostate cancer," said Dr. Oliver Sartor, chief of hematology/oncology at the Louisiana State University Health Sciences Center and co-chair of the congress. "I am very encouraged by the Acapodene Phase IIb data and I am impressed with the reduction in prostate cancer following repeat biopsies as well as the low toxicity of Acapodene."

Acapodene is a nonsteroidal selective estrogen receptor modulator, a small molecule that blocks estrogen receptors in the prostate.

June 3, 2004

ACAPODENE REDUCES RATE OF PROSTATE CANCER IN HIGH-RISK MEN, STUDY SHOWS

In a recent Phase IIb intent-to-treat analysis, GTx Inc.'s Acapodene (toremifene citrate) reduced prostate cancer incidence in patients at high risk for developing the malignancy.

The one-year, four-arm, double-blind study included 514 men with a high risk for prostate cancer, which was defined as having biopsy-proven precancerous prostate lesions called high-grade prostatic intraepithelial neoplasia (PIN). The subjects received 20, 40 or 60 mg of Acapodene or placebo orally once daily and underwent biopsy again at six and 12 months after randomization.

GTx said the results confirmed that patients with high-grade PIN are at high risk of developing prostate cancer: 31 percent of the patients in the placebo group received a prostate cancer diagnosis within one year.

As compared with the placebo arm, patients who received 20 mg of Acapodene for one year showed a 46 percent reduction in the incidence of prostate cancer.

Of the patients who developed prostate cancer, tumor grades were similar between the Acapodene and placebo groups.

GTx plans to initiate a Phase III trial with Acapodene this year after it meets with the Food and Drug Administration.

The company said it has licensed the worldwide rights to develop, market and distribute toremifene citrate from Orion Corp. for the prevention and treatment of prostate cancer. The drug is a small, nonsteroidal that modulates the estrogen receptor.