SAN FRANCISCO, June 26, 2017 /PRNewswire/ -- Dr. Stephen N. Birrell MD PhD presented breakthrough findings into the reduction of mammographic breast density at the 8th International Breast Densitometry and Cancer Risk Assessment Conference in San Francisco, California. The conference, Co-Chaired by University of California, San Francisco, and Karolinska Institutet; included presentations and posters by researchers from institutions across the world, including the Mayo Clinic and Queen Mary University of London.
Dr. Birrell, Chief Medical Officer and founder of HAVAH Therapeutics was an invited speaker at the internationally attended conference at the forefront of research into improved breast cancer screening, risk assessment and preventative strategies. Following years of research into the field of breast cancer treatment and prevention, this was the first-time Dr. Birrell's research into the reduction of mammographic breast density was presented in a scientific forum.
Study Design and Objectives
Dr. Birrell undertook a study to examine the effect of HAVAH Therapeutics' T+Ai™ (testosterone plus aromatase inhibitor) therapy that intends to mimic the effects of tamoxifen by reducing mammographic breast density in pre-menopausal women without perturbations in hypothalamic-pituitary function. 150 women undergoing mammographic screening and having high mammographic breast density as determined by a percent volumetric breast density (%VBD) measurement of equal to or greater than 15.5% volumetric breast density (%VBD) as measured by Volpara, were randomly chosen for inclusion in the study. A VBD of 15.5% is equivalent to a BI-RADS D classification.
The participants were allocated in a non-randomized fashion to either (a) follow-up mammography at 1 year for mammographic breast density calculation or (b) treatment with a subcutaneous pellet of testosterone (60-100 mg) and anastrozole (1-3mg) (dependent on BMI) every 4 months plus a follow-up mammogram for mammographic breast density calculation at 1 year. There were no significant differences in the base-line characteristics of each cohort. Hormone levels were evaluated every 4 months and follicular stimulating (FSH) and luteinizing hormones (LH) were compared from baseline to the same stage of each woman's menstrual cycle 3 months later. Serum anastrozole levels were measured at 1 and 4 months after treatment was commenced.
74 women were included in the cohort study, (2 lost in pre-screening). None were lost to follow-up during the study period. There was a small (2%) reduction in mean %VBD in the control group compared to the treatment cohort (19.5%). There was no significant change in either FSH or LH. There were no serious adverse events and no androgenicity events resulting in cessation of treatment.
In conclusion, testosterone combined with anastrozole is an effective method of reducing high mammographic breast density in pre-menopausal women by manipulating the amplified hormone catalytic enzymatic system of high mammographic breast density tissue to effect an alteration in the breast tissue estrogen to testosterone ratio; thus inducing a state of breast tissue involution commensurate with that occurring with tamoxifen chemoprevention. This was achieved with excellent tolerance and no adverse effect on hypothalamic-pituitary function.
Dr. Birrell's cohort study results were supported by a poster presentation regarding a secondary study on the effect of T+Ai™ in reducing breast tissue stiffness and breast pain in a cohort of 10 women. A clear signal was observed with all women experiencing a reduction in tissue stiffness and pain of 53% and 67% respectively.
About Mammographic Breast Density
High mammographic breast density is widely accepted as a strong independent risk factor for developing breast cancer and significantly limits the efficacy of breast imaging. Large-scale clinical studies with long-term follow up have demonstrated that a reduction in mammographic breast density is associated with a reduction in the instance of breast cancer whilst an increase is associated with greater instance in breast cancer. Furthermore, high mammographic breast density greatly reduces the sensitivity of mammograms and results in many false-negative readings, or missed cancers.
Uptake of tamoxifen therapy as a therapeutic intervention to reduce mammographic breast density and as preventative agent for breast cancer has not been successful in pre-menopausal women due, in part at least, to its significant side effects. Unfortunately, tamoxifen has a profound effect on hypothalamic-pituitary function in pre-menopausal women. Tamoxifen is unique in that it has both anti-estrogenic and androgenic action in normal breast tissue inducing involution like that seen in post-menopausal breast tissue. Whereas much of the estrogenic effect in high breast density tissue results from intracranial aromatase activity that converts testosterone to estradiol, when testosterone is preferentially metabolized to 5α-di-hydrotestosterone there is a profound reduction in estrogenic action on normal breast tissue.
About HAVAH Therapeutics
HAVAH Therapeutics is a San Francisco-based women's hormonal health biopharmaceutical company. We develop innovative, proprietary hormonal therapies that aim to improve quality of life for women across the world. We bring together a world-class team passionate about helping women live lives free from the suffering caused by breast pain, debilitating menopausal symptoms and breast cancer.
HAVAH Therapeutics lead drug candidate T+Ai™ is currently undergoing clinical trials into the reduction of mammographic breast density and breast cancer prevention.
Attn: Nicholas J. Birrell, CEO
Phone: +1 (650) 799-4635
228 Hamilton Avenue, 3rd Floor, Palo Alto, California 94301 (USA)
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SOURCE HAVAH Therapeutics