Ascend Therapeutics Presents Positive Data From Phase 2 Breast Tumor Cell Proliferation Study At Annual San Antonio Breast Cancer Symposium
December 6, 2003 - Herndon, VA ASCEND Therapeutics, Inc. announced today that it presented data from a Phase 2 dose-escalating study comparing the antiproliferative effect of the Company's percutaneous TamoGel™ (4-Hydroxytamoxifen gel) to oral tamoxifen on malignant breast cancer. The data was presented at the 26th Annual San Antonio Breast Cancer Symposium held December 3 - 6, 2003 in San Antonio, Texas.
Data from the study concluded that TamoGel™ has a local impact on tumor proliferation with much lower systemic exposure than tamoxifen, and that TamoGel can be tested in future prospective trials of chemoprevention or ductal carcinoma in situ (DCIS) adjuvant therapy.
This study was an important one for us," explained Dr. Dana Hilt, Chief Medical Officer, ASCEND Therapeutics. "In addition to the positive data from this trial, we have two separate Phase 2 studies currently ongoing in cyclic breast pain and reduction in breast density. These data released today show that 4-OHT gel can have a biologic effect on breast tumor cells in vivo in patients undergoing resection. These data also provide additional support for a potential role of this drug in chemoprevention of breast cancer in high risk patients."
The randomized study was designed to analyze if TamoGel™, administered percutaneously on the breast skin, can inhibit the proliferation of malignant breast tumor cells to the same extent as orally administered tamoxifen. Forty-nine postmenopausal women with an invasive estrogen-receptor-positive breast cancer were randomized to receive TamoGel™ (0.5, 1, or 2 mg/day as a topical gel), oral tamoxifen (20 mg/day), or no treatment. Response was evaluated using tumor cell proliferation markers (Ki-67, PCNA) and apoptosis markers in tissue samples obtained by Tru-cut biopsy before treatment and at surgery after approximately 3 weeks of treatment.
Administration of TamoGel™ for 2-3 weeks was well tolerated and resulted in reductions in tumor tissue proliferation indexes. The level of reduction was comparable between TamoGel™ 1.0 mg/day, TamoGel™ 2.0 mg/day, and oral tamoxifen (20 mg/day). Plasma levels of 4-OHT in the TamoGel™ group were lower in the Tamogel treatment groups relative to the oral tamoxifen group, supporting the hypothesis that therapeutic local effects can be achieved while minimizing systemic 4-OHT exposure.
"We are pleased to have results from our study presented at this important breast disease conference," noted Jay Bua, Chief Executive Officer of ASCEND Therapeutics. "We look forward to obtaining results from our current Phase 2 studies in the second half of 2004 and presenting them at future medical meetings.
About TamoGel™
TamoGel™ is a percutaneously applied gel formulation of 4-Hydroxytamoxifen (4-OHT) that is currently under investigation in a variety of benign and malignant estrogen-dependent conditions by ASCEND Therapeutics. 4-OHT is a metabolite of tamoxifen that is up to 100 times more potent than tamoxifen in inhibiting breast cell proliferation in vitro. (Malet, Cancer Research, 1988). TamoGel™ is formulated as an enhanced hydroalcoholic gel for transdermal delivery. I.e., the gel is applied directly to the surface of the breast, where it is absorbed into the breast tissue.
About ASCEND Therapeutics
Based in Herndon, Virginia, ASCEND Therapeutics, Inc. is a biopharmaceutical company engaged in the discovery and development of innovative therapeutic products for the treatment of underserved chronic conditions. ASCEND's initial product pipeline includes transdermal hydroalcoholic gel-based products in the areas of women's and men's health. ASCEND's gel product TamoGel™ is currently in two separate Phase 2 clinical trials for breast pain and breast density. DHT, its product for elderly hypogonadism, will begin Phase 2 trials in 2004.