Produktlinie

Product Line with 8-Prenylnaringenin


Project 1: needs approval from authorities
Working title: “SKIN-PIN-FORTE (mite, low)”
Therapeutic Area: Anti-aging skin (face, décolleté, preferably (but not exclusively) elderly women)
Application Form: Crème, Lotion, New Patch Forms (all topical)
Route of Administration: Dermal
Probability of Realization: High
Daily 8-PN dose (mg): max 1mg
Scientific Basis: Estradiol (dermal) is effective in the treatment of wrinkles
Schmidt et al: Treatment of skin ageing with topical estrogens; Int J Dermatol 35 (9): 669-674 (1996)
Time to Market (best guess): 1.5 – 2 years

Project 2: needs approval from authorities
Working title: “AGEART” (derived from HRT)
Therapeutic Area: Gynecology – Hormone Replacement Therapy (HRT)
Application Form: Tablet, coated Tablet, Capsule, Drinking solution
Route of Administration: Oral
Probability of Realization: Medium to High
Daily 8-PN dose (mg): 50mg (best guess)
Scientific Basis: 8-PN is an orally active estrogen, the problem is to find a dose that does not need to be counteracted by a progestin but has inhibitory effects on bone resorption and suppresses other symptoms in menopause (hot flashes, mood disturbances etc.)
Time to Market (best guess): 4-5 years

Project 3: needs approval from authorities
Working title: “AGEART PLUS
Therapeutic Area: Gynecology – Hormone Replacement Therapy (HRT)
Application Form: Tablet, coated Tablet, Capsule
Route of Administration: oral
Probability of Realization: high
Daily 8-PN dose (mg): 50mg 8-PN plus 20µg/d norgestrel or 35µg norethisterone acetate or 100µg drospirenone or any other progestin in an equivalent dose
Scientific Basis: Oral combined HRT products have been on the market for a long time. AGEART PLUS, the only product containing a plant derived estrogenic component, would compliment the universe of products already on the market.
Time to Market (best guess): 4-5 years

Project 4: needs approval from authorities
Working title: “GYNGENIN”
Therapeutic Area: Gynecology, Life-style preparation
Application Form: Lube, vaginal creme
Route of Administration: intravaginally
Probability of Realization: medium to high
Daily 8-PN dose (mg): 0.1 contained in 2.5 g crème (40µg 8-PN/g crème)
Scientific Basis: The effective area dose of 1 µg/cm² is derived from skin studies (Skin area dose was lowered by a factor of 2 because of expected higher rate and degree of absorption through the slightly damaged and mostly dry mucous membrane)
Time to Market (best guess): 2-3 years

Project 5: as dietary supplement no need for approval from authorities
Working title: “ARTECTION”
Therapeutic Area: Cardiovascular
Application Form: Tablet
Route of Administration: Oral
Probability of Realization: medium to high
Daily 8-PN dose (mg): 0.1 to 0.2 mg/day. This dose corresponds to the 8-PN content of 1 liter of hopped beer and is also able to compensate for the deficiencies in estradiol production in older men. This prevents losses in bone substance and libido or returns them to normal and prevents arteriosclerosis (via lipid metabolism).
Time to Market (best guess): 1 year

Project 6: as (dietary) supplement to an approved drug product it is a change in formulation but no new approval from authorities seems necessary
Working title: “ARTECTION-PASS
Therapeutic Area: CV
Application Form: Tablet, coated Tablet, Capsule
Route of Administration: Oral
Probability of Realization: medium to high
Daily 8-PN dose (mg): 0.5 – 1mg 8-PN/d plus 100mg ASS
Scientific Basis: see Project 5
Time to Market (best guess): 2 years

Contact

KAIROSmetics UG

Dr. Michael Hümpel
Am Volkspark 81
10715 Berlin
Deutschland

info@kairosmetics.de

Mobile: +49 173 2400598
FAX +49 451 39689516

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