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The objectives were to assess safety, tolerability and pharmacokinetics of both formulations of endoxifen over 28 days. All objectives were successfully met in the topical arms of online gambling reddit study. The topical formulation of our proprietary endoxifen is being developed for women with a condition call mammographic breast density, or MBD, which has been shown in third-party studies to result in a higher risk of online gambling reddit breast cancer.
To date, 30 U. Although oral tamoxifen has been shown to free slots for ipad MBD, the benefit-risk ratio is generally not acceptable what is online casino dealer most physicians and their patients. In mid we completed a Phase 1, placebo-controlled study of our proprietary topical Endoxifen. All objectives of that study were successfully met:.
The data from the Phase 1 study this web page the suitability of topical Endoxifen for further clinical development. We have initiated a Phase 2 study of our topical endoxifen in women with MBD.
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Research indicates that low endoxifen levels in breast cancer patients taking oral tamoxifen correlate with a higher risk of recurrence and new cancer as compared to breast cancer patients with adequate endoxifen levels.
Subject to favorable results from our Phase 1 study, we are planning to begin a Phase 2 study of oral endoxifen for these patients who are refractory to tamoxifen. We are also evaluating endoxifen in the neo-adjuvant setting, meaning it would be use to treat breast cancer before surgery to remove the cancerous tumor. We are online gambling reddit our patented microcatheter technology to deliver therapeutics through the nipple directly to the site of the cancer.
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Online gambling reddit is FDA-approved for metastatic breast cancer. It is administered as a monthly intramuscular injection of two injections, typically into the buttocks. We own one issued patent and several pending applications directed to the treatment of breast conditions, including cancer, by the intraductal administration of therapeutics, including fulvestrant. We read more currently conducting a Phase 2 study using our microcatheter technology to deliver fulvestrant at Montefiore Medical Center.
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The primary endpoint of the clinical trial is to compare the safety, tolerability and distribution of fulvestrant between the two routes of administration intramuscular injection or through our microcatheters.
The secondary endpoint of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimens. Digital breast imaging before and after drug administration in both groups will also be performed to determine the effect of fulvestrant on any lesions as well as breast density of the participant.
We plan to use our proprietary intraductal microcatheter technology to deliver CAR-T cells into the ducts of the breast for the potential targeted treatment of breast cancer.
We believe this method has several potential advantages: Casino with no deposit bonuses program is in the research and development phase and has not been approved by the FDA or any other regulatory body. Pre-clinical studies, and clinical studies demonstrating safety and efficacy among other things, and regulatory approvals will be required before commercialization. Chin J Cancer Res. The T cells, which can then recognize and kill the cancer cells, are reintroduced into the patient using a microcatheter into the online gambling reddit ducts of the breast.
Typically, these receptors are used to graft the specificity of a monoclonal antibody onto a T cell, with transfer of their coding sequence facilitated by retroviral vectors. The receptors are called chimeric because they are composed of parts from different sources.
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