Clinical Trials

Clinical Trials

A phase I, placebo controlled, dose escalation safety and pharmacokinetic study of (Z)-Endoxifen in healthy female volunteers.

This double-blinded study consisted of two parts:

1) A three-arm placebo controlled study with our proprietary formula of Topical Endoxifen amongst 24 volunteers; and

2) A three-arm placebo controlled study with our proprietary Oral Endoxifen amongst 24 volunteers, in both single and multiple dose administrations. One woman in the Topical Part (receiving placebo) was dropped due to lack of compliance and replaced.

Findings

Parameter Topical Endoxifen Oral Endoxifen
Safety There were no reported significant adverse safety events There were no clinically significant safety signals and no clinically significant adverse events in participants receiving oral Endoxifen
Tolerability Topical endoxifen at the dose levels and for the dosing duration utilized in the study was well tolerated by the study subjects Oral Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study
Pharmacokinetics Higher levels of endoxifen was achieved in the blood of subject who received higher doses of the topical drug Oral Endoxifen demonstrated blood levels that have been associated with a therapeutic effect in the adjuvant setting in women with breast cancer

A phase I, placebo controlled, dose escalation safety and pharmacokinetic study of Topical Endoxifen in healthy male volunteers.

This double-blinded study consisted a three-arm placebo controlled study with our proprietary formula of Topical Endoxifen amongst 24 volunteers; the design was identical to that of the female study.

Findings (Preliminary)

Parameter Preliminary Results
Safety There were no clinically significant safety signals and no clinically significant adverse events in participants receiving topical Endoxifen
Tolerability Topical Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study
Pharmacokinetics Topical Endoxifen was either at or below the limit of quantitation

AG-1001-AU-02: An open label, pilot and expansion pharmacodynamic Study of (Z)-endoxifen in Patients with Invasive Breast Cancer Prior to Undergoing Mastectomy or Lumpectomy.

This study is designed to determine if Oral Endoxifen “turns’ down” or reduces tumor cell activity in patients with newly diagnosed estrogen receptor positive breast cancer. Participating patients will receive Oral Endoxifen for at least 21 days prior to surgery, or during the “Window of Opportunity.” Tissue samples obtained from the initial biopsy and again at surgery will be analyzed and results compared to determine if cancer cell activity is lower following Oral Endoxifen administration. If a reduction in tumor cell activity is reduced in at least two of the first eight patients, then the study will be expanded to enroll an additional 17 patients.

This study is being conducted by Dr. Vinod Ganju, Peninsula & South Eastern Haematology & Oncology Group, Franksten, Victoria, Australia.

ATOS-009: KARMA CREME-1: A DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARMED, PILOT STUDY OF THE EFFECTS, SAFETY AND TOLERABILITY OF TOPICAL ENDOXIFEN IN HEALTHY WOMEN

Ninety healthy menopausal women will be enrolled to assess the effect, safety and tolerability of Topical Endoxifen. The investigational medicine will be applied daily for up to 6 months. Mammograms will be performed at 3 and 6 months to ascertain if mammographic breast density is reduced. Randomization is 1:1:1 (0, 10 and 20 mg/day).

This study is being conducted by Per Hall, MD, at South General Hospital, Stockholm, Sweden. Dr. Hall is Professor, Karolinska Institutet, Institution for Medical Epidemiology and Biostatistics, and the Department of Oncology, Södersjukhuset.

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AN OPEN LABEL, PHASE 2 PHARMACOKINETIC STUDY OF PRE-SURGICAL INTRAMUSCULAR AND INTRADUCTAL FULVESTRANT IN WOMEN WITH INVASIVE BREAST CANCER OR DCIS UNDERGOING MASTECTOMY OR LUMPECTOMY

Up to 30 women newly diagnosed patients with Stage 1 or 2 invasive ductal carcinoma or DCIS, prior to mastectomy or lumpectomy will be enrolled. This study will compare the effect of fulvestrant when administered by two different routes. Six women will receive a single dose of fulvestrant as directed in the prescribing information, i.e., via one or two intramuscular injections into the buttocks. The other 24 women will receive a single dose of fulvestrant via intraductal (through the nipple into the milk ducts) infusion to the site of the cancer. Surgery will be performed at least 14-days but no longer than 50-days following fulvestrant administration. Tissue samples obtained from the initial biopsy and again at surgery will be analyzed and results compared to determine if there is any difference in cancer cell activity between the two routes of administration.

This study is being performed Sheldon Feldman, MD, at Montefiore Medical Center, Brooklyn, New York.

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