Encouraged by the data gained in the exploratory study with RPHE-7193, Robert Gadimian announces that Rophe Pharma is in the process of raising the funds needed to conduct the IND-enabling studies in order to open its first IND with the FDA and initiate its first Phase 1/2 study in US where RPHE-7193 will be studied head-to-head against minoxidil. The study will be designed to demonstrate clinical and statistical superiority against minoxidil.
EXCITING RESULTS WITH NEW HAIR GROWTH PRODUCT
In the exploratory study conducted with RPHE-7193 significant hair growth is observed in men after only 4-8 weeks of use, indicating this treatment may bring hope in fight against hair loss to millions.
EXISTING HAIR GROWTH PRODUCTS HAVE LIMITED RESULTS
According to the America Hair Loss Association, MPB – also referred to as androgenetic alopecia — accounts for more than 95% of hair loss in men. By the age of 35, two-thirds of American men will experience some degree of appreciable hair loss; by the age of fifty, approximately 85% of men will contend with significantly thinning hair. Approximately 25% of men who suffer with MPB began the painful process of losing their hair before reaching the age of 21. For men unhappy with MPB the effects can be wide-ranging and affect quality of life, both personal and professional. In spite of this wide spread issue, no drug has been able to satisfactorily solve MPB in all men.
ACTIVE INGREDIENT IS ALREADY APPROVED BLOOD PRESSURE DRUG
Hydralazine, or, RPHE-7193, like minoxidil, is a blood pressure drug with hair growth as side effect and was approved decades ago for treatment of blood pressure but has hair growth as side effect.
FIFTY MILLION PEOPLE SUFFERING HAIR LOSS COULD BE HELPED
And some estimates put that number higher. Robert Gadimian says Rophe Pharma is poised to get their new product, RPHE-7193 into this market. After fund raising Rophe Pharma will expand research into market segments and demographics not yet studied. The two already approved drugs for male pattern baldness (MPB) have not been studied in men above age 41 but Robert Gadimian is testing RPHE-7193 in that age group — since as mentioned above, most of the men who suffer from hair loss are above age 41.
AHLA ADVISES USING ONLY FDA APPROVED TREATMENTS
Minoxidil and finasteride currently constitute the only two FDA-approved drugs for hair loss treatment. Millions more remain vigilant and eagerly poised for the introduction of legitimate and approved pharmaceutical drugs that would expand their range of choices. This has led the American Hair Loss Association to address the questionable hair treatment therapies on the market and warn its members to use hair loss treatments that are approved by the FDA.:
Under Gadimian’s guidance, Rophe Pharma is planning to conduct the required studies by the FDA to get the product approved and bring to market the desperately needed hair growth drug that will work for most men in all age groups.