Contact Us
HavaH Therapeutics, Pty Ltd
- Nyroca House
- 10-20 New Street
- North Adelaide, South Australia 5006 Australia
- +61 8 7200 5606
- hi@havahtx.com
Developing androgen therapies for breast disease by utilizing the innate breast-tissue-specific hormone/immune interface
Who We Are
Havah has completed world leading pre-clinical and clinical trials (Phase I,II and III) to develop androgen-based pharmaceuticals for use in breast disease.
Havah is one of the first biotechs to utilize the breast tissue specific innate hormone/immune interface.
Background
Androgens are an essential hormone in both men and women-the balance between estrogens and androgens is critical in the maintenance of hormonal homeostasis and the interface between hormonal function and the immune system.
Havah Therapeutics lead product delivers a unique androgen product to effect a beneficial tissue specific alteration in estrogen:androgen ratio and reduce breast tissue autoimmune inflammation
The Market
An unmet need as recently declared in A Global Consensus Position Statement on the Use of Testosterone Therapy for Women that:
“As no approved female product is presently approved by a national regulatory body, the panel highlighted the pressing need for more research into testosterone therapy for women and the development and licensing of products indicated specifically for women.”
Orphan indications in rare breast disease where autoimmunity is the underlying mechanism of the pathogenesis e.g. granulomatous and peri-ductal mastitis
Reducing high mammographic breast density known to be associated with;
Reducing high mammographic breast density known to be associated with;
- An increased risk of breast cancer
- An increased difficulty of breast cancer detection
- Reducing side-effects of breast cancer treatment
Introduction
There have been over last 20 years many attempts at trying to introduce an androgenic product for women. For numerous reasons there have been no successful registered products available for clinicians despite over 4 million off label prescriptions per annum being written for a testosterone product for women in the USA alone.
A recent consensus opinion from the representative clinical colleges outlined the importance of a registered product being made available for women diagnosed with hypoandrogenism. This would then open the door for multiple other uses for androgenic products as a therapeutic intervention in conditions which are being targeted by company such as HavaH Therapeutics.
HavaH Therapeutics is dedicated to developing androgenic products for women and draws on an extensive international network of experts.
After 30 years of preclinical and clinical research into androgen function in women I intend to use this blog to elaborate on how I personally view the developments occurring in the andrology of women.
HavaH Therapeutics is dedicated to developing androgenic products for women and draws on an extensive international network of experts.
After 30 years of preclinical and clinical research into androgen function in women I intend to use this blog to elaborate on how I personally view the developments occurring in the andrology of women.
Stephen N Birrell
MD PhD
Founder and Chairman
HavaH T+Ai Therapy
THE BASIS OF T+Ai THERAPY
Shifting the fulcrum of the breast tissue testosterone: estradiol axis to cause favourable breast tissue specific change by utilising the dimorphic nature of natural testosterone i.e whether it covers to the potent androgen 5α-dhydrotestosterone (DHT) or estradiol
Executive Staff
Stephen N Birrell, Founder and Chairman
Founder and inventor, 30-year breast cancer specialist/surgeon and renowned medical innovator, clinical oncologist, widely published molecular oncologist in leading journals incl. Nature, founder/ pioneer of three leading (Australian) multi-disciplinary breast centres in both the public and private sectors. Dr Birrell, with his scientific research partner, Prof Wayne Tilley, are internationally recognized for pioneering the use of androgens in breast disease.
MD PhD FRACS
Kathy Harrison, CEO
Biotech company leader with 30 years industry experience including 9 years in patent attorney practice. Leadership roles in biotech companies have included CEO of ASX listed Dimerix Ltd and current Director of Estrenue Pty Ltd. Kathy has extensive experience in intellectual property strategy, commercial drug development strategy and achieving drug development milestones. Kathy’s qualifications in science, intellectual property law and governance provide the depth of skill to lead HAVAH through its next stage of growth.
MSc, FIPTA, GAICD
Tim Luscombe, CFO and Company Secretary
Tim is a Director of Bio101 who provide outsourced CFO, company secretarial and corporate advisory services to the healthcare sector. A Qualified Chartered Accountant, Tim has extensive experience in providing financial advice, company secretarial and CFO services to Healthcare businesses ranging from ASX listed entities to Not-for-Profit organisations. Tim is CFO and Company Secretary for a number of ASX listed, public unlisted and private companies in the medical technologies, medical devices, biotechnologies and pharmaceuticals sectors. Tim holds a Bachelor of Commerce from the University of Melbourne and a Certificate in Governance Practice from the Governance Institute of Australia.
Joe Schacter, Business Development
Previous experience with Business Development and Operations at two technology startups. Prior to that, Joe was an Analyst on the licensing team at Torreya Partners, a boutique advisory firm in New York. He helped Torreya source Iota Biosciences, which Torreya founded and then was acquired by Astellas
Presentations
Dr Stephen Birrell talk about testosterone in gynaecology at a National Meeting June 4th 2022
Advisory Board
- Prof. Jack Cuzick, CBE FRS
- John Snow Professor of Epidemiology Queen Mary University UK
- Prof Anthony Howell
- Professor of Oncology Manchester University UK
- Prof Charles Loprinzi
- Susan Komen Regis Professor of Oncology Mayo Clinic MN USA
- Prof Laura Esserman
- Prof Surgery and Radiology UCSF USA
- Prof Neal Rosen
- Director of Cancer Research MSKCC USA
- Prof Suzanne Fuqua
- Head Molecular and Cellular Biology, Baylor College Houston USA
- Prof Ed Gelman
- D-Director for Clinical Research, HICCC Columbia University NY USA
- Prof Jason Carroll
- Director Breast Cancer Research, Cambridge Institute Cambridge Uni UK
- Prof Karen Knudsen
- Chief Executive Officer of American Cancer Society
- Prof Ganesh Raj
- Dr Paul Peters Chair in Urology UT Southwestern USA
- Prof Tom Fleming
- Prof of Biostatistics University of Washington USA
- Prof Wayne Tilley
- Dame Roma Mitchell Chair of Cancer Biology University of Adelaide Australia
- Dr Scott Berry
- CEO Berry Consultants Austin TX USA
- Prof Don Berry
- Prof Dept of Biostatistics UT MD Anderson Houston USA
- Dr Lois Rosenberger
- CEO LBR Consulting KY USA
- Mr John Ramsey
- ex-Director Global Drug Development AstraZenca UK