在健康女性志愿者中,(Z)dendoxifen的I期,安慰剂控制的,剂量升级的安全性和药代动力学研究。

This double-blinded study consisted of two parts:

1)在24名志愿者中,我们专有局部内昔芬的三臂安慰剂对照研究;和

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

范围 局部内昔芬 口服内昔芬
Safety There were no reported significant adverse safety events 没有临床上明显的安全信号,并且在接受口服内昔芬的参与者中没有临床明显的不良事件
Tolerability 研究受试者可以很好地耐受剂量水平的局部昔夫蛋白的剂量水平和剂量持续时间 口服内昔芬在每个剂量水平和研究中使用的剂量持续时间都得到很好的耐受性
药代动力学 Higher levels of endoxifen was achieved in the blood of subject who received higher doses of the topical drug 口服内昔芬表现出与乳腺癌女性辅助环境中治疗作用有关的血液水平

AG-1001-AU-02:在进行乳房切除术或乳房切除术之前,对浸润性乳腺癌患者的(Z) - 糖蛋白的开放标签,试验和扩张性药效学研究。

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:

  • 在初始活检和手术之间,每位患者的KI-67在每位患者中降低了50%以上,总体降低了74%。
  • 所有六个病人ki - 67治疗后25%以下ment. 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.
  • 治疗范围为16-40天,平均22天。
  • 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.

AT-301-AU-01:健康成年人对AT-301鼻喷雾的双盲,随机和安慰剂对照的安全研究。

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.

该研究总共将32名健康的成年受试者招募成一个单一升剂剂量组或一个多种剂量的多种剂量组。

This study was conducted in Australia.

盲目的初步结果:

  • AT-301在单剂量或多剂量下似乎是安全且耐受性良好,持续14天。
  • 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.