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

Parameter 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.

 

Interim Results: The open-label study was designed to permit an interim analysis of the Ki-67 change. The requirement was to achieve a meaningful Ki-67 change in at least two of eight patients. Interim results are as follows: All patients (N=6) experienced a significant reduction in Ki-67. A summary of these results includes:

  • Ki-67 was reduced by more than 50% in every patient in the window of opportunity between initial biopsy and surgery, with an overall reduction of 74%.
  • All six patients had a Ki-67 below 25% after treatment. In a paper entitled, “Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients,” Ki-67 was an independent prognostic value for predicting overall survival in ER+ breast cancer patients. Ki-67 levels below 25% were associated with the lowest risk of death in this systematic review and meta-analysis.  
  • Treatment ranged from 16-40 days with an average of 22 days.
  • There were no safety or tolerability issues, including vasomotor symptoms such as hot flashes and night sweats, which are often a tolerability challenge for patients on tamoxifen.

ATOS-010: 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 were enrolled to assess the effect, safety and tolerability of Topical Endoxifen. The investigational medicine was applied daily for up to 6 months. Mammograms were performed at 3 and 6 months to ascertain if mammographic breast density was reduced. Randomization was 1:1:1 (0, 10 and 20 mg/day).

This study was 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.

 

See Results ->

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AT-301-AU-01: A PHASE 1, DOUBLE-BLINDED, RANDOMIZED, AND PLACEBO-CONTROLLED SAFETY STUDY OF AT-301 NASAL SPRAY IN HEALTHY ADULTS.

This study was designed to determine the safety and tolerability of AT-301 nasal spray which is being developed for at home use for patients recently diagnosed with COVID-19.

The study enrolled a total of 32 healthy adult subjects into either a single ascending dose group or a multiple ascending dose group each with two different doses.

This study was conducted in Australia.

Blinded Preliminary Results:

  • AT-301 appears safe and well tolerated at single or multiple doses for 14 days.
  • There were no serious adverse events, no discontinuations, and only one subject of the 32 subjects experienced adverse events that were considered moderate in severity. All other adverse events were considered mild.

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