Atossa Therapeutics Unveils Positive Results from KARISMA-Endoxifen Trial
(Z)-Endoxifen has been shown to significantly reduce mammographic breast density, potentially leading to groundbreaking strategies for cancer prevention.
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a biopharmaceutical company operating in the clinical stage with a dedication to developing innovative solutions for breast cancer, has recently released encouraging topline data from its Phase 2 KARISMA-Endoxifen study. This trial focused on the effects of (Z)-endoxifen among premenopausal women with elevated mammographic breast density (MBD).
Key Insights from the Study
The trial, overseen by the esteemed Karolinska Institute, showed that low dosage levels of (Z)-endoxifen led to a noteworthy reduction in MBD while being generally well tolerated by participants. Detailed insights from the study indicated that the Atossa-sponsored ATOS-016R trial randomized healthy women into groups receiving either placebo or doses of 1 mg and 2 mg of (Z)-endoxifen, with 80 women in each group. The duration of this research spanned six months.
The change in mammographic density served as a crucial indicator for therapy response, with endpoint comparisons made relative to baseline measurements. Results revealed a statistically significant change in density: a reduction of 19.3 percent for the 1 mg group and 26.5 percent for the 2 mg group when benchmarked against the placebo group. Impressively, no major differences in demographic factors such as age or BMI were reported across the randomization arms.
Interestingly, prior research has noted that women experiencing a decrease in breast density—around 10 percent or more—while on tamoxifen saw a remarkable reduction in breast cancer incidence, making these findings particularly relevant.
Adverse Effects and Tolerability
Throughout the trial, no significant changes emerged in hematological safety tests or vital signs, adding to the safety profile of the treatment. Plasma concentrations of (Z)-endoxifen after one month were recorded at 5.18 ng/mL for the 1 mg dosage and 10.87 ng/mL for the 2 mg dosage, maintaining consistency at the three and six-month marks.
While a few participants experienced side effects leading to discontinuation—four for the placebo group, five for the 1 mg, and twelve for the 2 mg group—none reported vasomotor symptoms as a reason for exiting the study. Assessment via a validated questionnaire indicated only minor increases in these symptoms across treatment groups.
The Importance of Addressing Mammographic Breast Density
In the U.S., nearly half of women undergoing mammograms have dense breast tissue; while this condition is not uncommon and considered non-abnormal, it complicates the detection of tumors on mammograms and independently increases the risk for developing breast cancer.
Looking Ahead
Dr. Steven Quay, Chief Executive Officer of Atossa Therapeutics, expressed his enthusiasm regarding the topline results, emphasizing the significance of this study for preventive approaches to breast cancer. As analysis of the trial continues, the potential of (Z)-endoxifen, particularly the 1 mg dosage, to effectively decrease breast density—comparable or superior to existing therapies—opens new doors for millions of women facing challenges associated with dense breast tissue.
As Atossa and the Karolinska Institute prepare to present detailed results at an upcoming symposium, the anticipation grows. Publication in a peer-reviewed journal next year is also on the agenda, further validating these key findings.
About (Z)-Endoxifen
(Z)-endoxifen stands out as a highly effective Selective Estrogen Receptor Modulator (SERM) that may not only inhibit estrogen receptors but also engage in receptor degradation. This compound has shown promise even in cases where other hormonal treatments have failed and engages a powerful oncogenic protein known as PKC?1 within clinically relevant blood concentrations. Preliminary studies suggest that (Z)-endoxifen could maintain or even enhance bone benefits while minimizing endometrial effects in comparison to standard treatments.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is committed to advancing innovative medical treatments in oncology, specifically concentrating on utilizing (Z)-endoxifen to develop preventive and therapeutic strategies for breast cancer. For detailed information about their initiatives and research, visit their official website.
Contact Information
Michael Parks, VP Investor and Public Relations
484-356-7105
michael.parks@atossainc.com
Frequently Asked Questions
What is (Z)-endoxifen?
(Z)-endoxifen is a powerful selective estrogen receptor modulator, which is instrumental in developing therapies for breast cancer by effectively managing breast density.
Why is mammographic breast density important?
Breast density is a critical factor as it can hinder the effectiveness of mammograms and is often associated with a higher risk of breast cancer.
What were the main results of the KARISMA-Endoxifen study?
The study showed a significant reduction in breast density with (Z)-endoxifen, supporting its potential as a safe preventive treatment for breast cancer.
How was the trial conducted?
The trial was a randomized phase 2 study involving healthy women, comparing the effects of placebo and (Z)-endoxifen over six months.
What are the next steps for Atossa Therapeutics?
The company plans to present detailed findings at medical conferences and is working toward publishing results in a peer-reviewed journal.
