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We currently have four programs underway: Endoxifen is the most active metabolite ingredient of the FDA-approved drug tamoxifen, which has been used since its approval in for breast cancer survivors to prevent recurrence as well as the development of new cancer. We are developing both oral and a topical formulation of endoxifen. In mid we completed a Phase 1 clinical study which was conducted by a leading Clinical Research Organization in Australia.

The study was a placebo-controlled, repeat dose study of 48 healthy female volunteers. The objectives read article to assess safety, tolerability and pharmacokinetics of both formulations of endoxifen over 28 days.

All objectives were successfully met in the topical arms of the 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 developing breast cancer.

To date, 30 U. Although oral tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most physicians and their patients. In mid we completed a Phase 1, placebo-controlled study of our proprietary topical Endoxifen. All this web page of that study were successfully met:. The data from the Phase 1 study demonstrate the suitability of topical Endoxifen for further clinical development.

We have initiated a Phase 2 study of our topical endoxifen in women with MBD. The study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Best ndb online casino blog. Per Hall, MD, Ph.

The placebo-controlled, double-blinded study is expected to enroll up to subjects. The primary endpoint is MBD reduction, which will be measured after six and twelve months of dosing, as well as safety and tolerability. Research indicates that low endoxifen levels in breast best ndb online casino blog 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, casino bonus sin deposito it would be use to treat breast cancer before surgery to remove the cancerous tumor. We best ndb online casino blog developing our patented microcatheter best ndb online casino blog to deliver therapeutics through the nipple directly to the site of the cancer.

The goals of this delivery method are to increase the amount of the therapy getting to the targeted area while reducing the side effects that would otherwise be caused by delivering the drug through the blood stream.

We believe our patented intraductal microcatheter technology may be useful in delivering a number of drugs directly to the breast best ndb online casino blog. The initial drug we are studying using our microcatheters is fulvestrant. Fulvestrant 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 are currently conducting a Phase 2 just click for source using our microcatheter technology to deliver fulvestrant at Montefiore Medical Center.

This trial is a Phase 2 study in women with ductal carcinoma in situ DCIS or Stage 1 or 2 breast cancer invasive ductal carcinoma scheduled for mastectomy or lumpectomy within 30 to 45 days. This study is assessing the best ndb online casino blog, tolerability, cellular activity and distribution of fulvestrant when delivered directly into breast milk ducts of these patients compared to those who receive the same drug by injection. Of the 30 patients required for full enrollment, six will receive the standard intramuscular injection of fulvestrant and 24 will receive fulvestrant with our microcatheter device.

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: This 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 natural ducts of the breast. Typically, these receptors are used barona casino graft the specificity of a monoclonal antibody onto a T cell, with transfer of their coding sequence facilitated by retroviral best ndb online casino blog. The receptors are called chimeric because they are composed of parts from different sources.

Endoxifen Endoxifen is the most active metabolite ingredient of the FDA-approved drug tamoxifen, which has been used since its approval in for breast cancer survivors to prevent recurrence as well as the development of new cancer. All objectives of that study were successfully met: There were no check this out significant safety signals and no clinically significant adverse events in participants receiving topical Endoxifen.

Topical Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study. Topical Endoxifen crossed the skin barrier when applied daily to the breast, as demonstrated by low but measurable Endoxifen blood best ndb online casino blog detected in a dose-dependent fashion.

Microcatheter Technology We are developing our patented microcatheter technology to deliver therapeutics through the nipple directly to the site of the cancer.


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