Invented by Morris A. Mann, RegeneRx Biopharmaceuticals Inc

Alopecia, commonly known as hair loss, is a condition that affects millions of people worldwide. It can be caused by a variety of factors, including genetics, hormonal imbalances, stress, and certain medical conditions. While there are several treatments available for alopecia, many of them are expensive and have limited effectiveness. This has led to a growing demand for hair regeneration compositions that can effectively treat alopecia and promote hair growth. The market for hair regeneration compositions for the treatment of alopecia is rapidly expanding. According to a report by Grand View Research, the global hair loss treatment market is expected to reach $12.6 billion by 2024. This growth is driven by an increasing number of people suffering from hair loss, as well as advancements in technology and research that have led to the development of more effective hair regeneration compositions. There are several types of hair regeneration compositions available in the market, including topical solutions, oral medications, and hair transplant surgeries. Topical solutions are the most commonly used form of hair regeneration compositions. These solutions are applied directly to the scalp and work by stimulating hair follicles and promoting hair growth. Some of the most popular ingredients in these solutions include minoxidil, finasteride, and ketoconazole. Oral medications are another form of hair regeneration compositions that are used to treat alopecia. These medications work by blocking the production of DHT, a hormone that is responsible for hair loss. Some of the most commonly used oral medications for alopecia include finasteride and dutasteride. Hair transplant surgeries are a more invasive form of hair regeneration compositions. This procedure involves removing hair follicles from one area of the scalp and transplanting them to another area. While this procedure can be effective, it is also expensive and requires a significant amount of downtime for recovery. In addition to the different types of hair regeneration compositions, there are also several methods of application related thereto. These methods include derma rollers, laser therapy, and platelet-rich plasma (PRP) therapy. Derma rollers are small handheld devices that are used to create tiny punctures in the scalp, which stimulates hair growth. Laser therapy involves using low-level lasers to stimulate hair follicles and promote hair growth. PRP therapy involves injecting a patient’s own blood plasma into the scalp, which contains growth factors that stimulate hair growth. In conclusion, the market for hair regeneration compositions for the treatment of alopecia is growing rapidly. With advancements in technology and research, there are now several effective treatments available for hair loss. Whether it’s through topical solutions, oral medications, or hair transplant surgeries, there are several options available for those suffering from alopecia. Additionally, the different methods of application related thereto provide patients with even more options for treating their hair loss. As the market continues to expand, it’s likely that we will see even more innovative treatments for alopecia in the future.

The RegeneRx Biopharmaceuticals Inc invention works as follows

The compositions for hair regeneration containing T1?1, T4?4 or a combination of these are disclosed. The treatment methods are: (1) cleaning the scalp with an agent for cleansing; (2) treating it with a keratin solution system; (3) applying an anesthetic; (4) applying an acids peel solution; and (5) applying an hyperactive urea formula.

Background for Hair Regeneration Compositions for Treatment of Alopecia, and Methods of Application Related Thereto

Alopecia is a serious problem that has plagued mankind and animals for many thousands of years. Alopecia can cause embarrassment and psychological problems such as depression in many people. It also affects their self-image and sexuality. Alopecia is thought to be caused by a variety of etiologies that affect both males and women, including gonadal steroids. Alopecia (male pattern baldness, androgenic hair loss, etc.) is more common among men than women. Cosmetic research has spent millions of dollars on this research and thousands of hours to find a solution.

Hair loss is a normal phenomenon.” The cycle of hair growth includes the development and birth of the follicle as well as a phase in which the hair is shed. The hair follicle secretes a specific substance that causes the alternation of phases between growth (anagenic phase), regression, (catagenic) and rest (telegenic phase). This gland-like structure gradually produces a mass keratin and then eliminates it and replaces it after a period of rest. The cycle starts with the growth of the hair-follicle which rises from the dermis, containing large numbers of mesenchymatous (mesodermal) cells. This results in the formation a dermal papula. The cells that surround the dermic-papilla undergo a 12-hour active division to produce cells that line up, become longer and start to keratinize. Hair growth. In the catagenic stage, mitosis is no longer occurring and the bulb separates from the papilla to rise towards the surface. The hair has been fully keratinized in the telogenic stage and is ready for expulsion. “After three to four month, another mitotic phase begins in the germination area of the hair. A new hair follicle forms.

The art still needs methods and compositions to treat alopecia. This invention fills this need, and also provides other related benefits.

The present invention is a method that can be used to treat alopecia. It is based on a discovery that the primary reason for alopecia among humans and warm-blooded animals is a reduction in cell-mediated immune system. Alopecia androgenetica is a condition that occurs very rarely before puberty. This is because puberty causes an increase in estrogens and androgens. Alopecia areata, alopecia Totalis and cell-mediated immune deficiencies are directly linked to alopecia. The thymus, which controls cell-mediated immune system, also involutes during puberty. The hypothesis was then that hair loss was likely caused by an infectious agent. Hair loss is rare without inflammation. In order to find out the cause of inflammation, which is responsible for alopecia in its various forms, we conducted investigations. To determine the infectious agent we developed chemical systems to solubilize Keratin, and chemical systems which induce significant exfoliation.

It has been discovered that a fungus causes virtually all hair loss. The fungus is located at the junction of dermal and epidermis. It can be seen with Wood’s Lamp (UV) radiation. The fungus on the scalp is a species of trichophyton with a sex-dependent variation. The type of fungal growth on male scalps is genetically distinct from that on female scalps. Despite not wanting to be tied down by this theory it is believed this fungus is a primary cause of hair loss. This fungus can be spread by ectoparasites, which is also surprising. The parasitic organism was isolated and analyzed under a microscope. It was found to belong to the demodicidea species. This parasitic organism has been detected in all test subject who have experienced hair loss.

The present invention provides compositions, methods, and apparatuses to eliminate the ectoparasite and resolve the problem of fungal infection, thus treating alopecia in the scalps of warm-blooded animals, including humans, who are in need. The phrase “treating alopecia” is used to refer to stimulating and/or regeneration hair growth through topical application of a composition for hair regeneration of this invention. The term “effective amount” is used in this document to refer to an amount of a hair regeneration composition that stimulates or regenerates hair associated with hair loss affiliations such as male pattern hair loss.

The hair regeneration compositions of the invention may contain T1 or T4 and optionally a steroid. They can also contain an indole-based substance, a mitocide, a bioflavanoid, an antifungal material, an antiinflammatory fatty acid, and/or an absorption enhancer.

As used herein, T?1 and T?4 are isolated extracts of thymosin fraction 5; a steroid includes tamoxifen citrate, progesterone, pregnenolone, spironolactone, pregneaolone, dehydroepiandrosterone (DHEA), diosgenin, triphenylethylene based compounds and/or testolactone; an indole-based compound includes indole, melatonin, N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide, skatole, and/or indole-3-carbinol; a mitocite is a solution of surfactant, fragrance and skin penetrant, wherein the skin penetrant includes PX-13, the surfactant includes GEMTEK surfactant (GEMTEK is a proprietary non-ionic surfactant that comprises an alkyloxypolyethyleneoxyethanol, a non-ionic alcohol ethoxylate surfactant, monoethanolamine, tall oil fatty acids, an alkylopolyglycoside surfactant, a tetrasodium salt of ethylenediaminetetraacetic acid (EDTA), with the balance being deionized water), and the fragrance includes menthol, benzyl alcohol, eugenol, phenoxyethanol, isopropyl palmitate, isopropyl myristate, benzyl salicylate, phenylethyl salicylate, thymol, isoamyl salicylate, phenylethyl salicylate, TRITON X-100 surfactant (TRITON X-100 is a octoxynol-9), benzoic acid, benzyl benzoate, methyl salicylate, phenol, oleic acid, caproic acid, and/or carbaryl; a bioflavanoid includes querretin methyl chalcone; an anti-fungal material includes undecylenic acid, griseofulvin, terbinafine and/or an azole compound; an anti-inflammatory fatty acid includes TES TRIOLATE (TES TRIOLATE is a tris-oleoyltromethamine ethane sulphate phospolipase A-2 inhibitor) and/or PX-13; and a skin absorption enhancer includes khellin, methyl nicotinate, MSM-Decy methyl sulfoxide, diethylene glycol, citric acid, pyruvic acid, phenoxyethanol, transcutol, GEMTEK surfactant, phosphatidyl choline, MCT oil and/or water.

The methods of the invention for treating alopecia comprise the steps of cleaning the scalp with a cleansing agent, treating the cleaned scalp with a Keratin Solvent System, applying an acid peel to the keratin-treated scalp and applying the hair regeneration compositions of the invention to the acid peeled skin. The methods of the invention include an optional step that involves applying a topical numbing agent after the scalp is treated with a keratin solution system, but before the application of the acid peel. These topical anesthetics are preferably formulated with a surfactant to enhance penetration, and a solubilization solution that facilitates penetration. Another optional step is the application of hyperactive urea formulations to dissolve bumps on the scalp surface. This optional step occurs after the application of the acid peel solution, but before the application of the hair-regeneration composition.

Cleaning the scalp can be done with a shampoo that contains a GEMTEK solution, a hard surface ethoxylated cleaner. The keratin solution system may include a urea solution, an acidic solution and/or gel formulations containing urea, citric, urea peroxide, propylene, glycol and ethoxylated alcohol. The acid peel solution contains a physiological acids. The optional GEMTEK solubilization and surfactant composition contains GEMTEK. “The optional formulation of hyperactive urea includes urea and citric acid. It also contains urea-peroxide. 2-phenoxyethanol. Propylene glycol. GEMTEK SC 1000.

The following detailed description will reveal these and other aspects.

As mentioned above, this invention discloses compositions for treating alopecia through topical application of a hair-regeneration composition to a patient’s scalp. The hair regeneration composition can be administered in any way that will deliver an effective amount to the animal. This includes delivery to hair follicles. The administration can be done by applying the topical composition directly to the scalp or any other area that is desired for hair stimulation.

The hair regeneration composition has been formulated for topical application. Topical formulations suitable for hair regeneration include liquids, lotions, creams, and gels. Topical administration can be done by applying directly to the scalp or another area. This can be done by applying a liquid or lotion formulation to the scalp or by rubbing it on. The topical formulation can be applied in any quantity that is sufficient to speed up hair growth. Treatments may be repeated according to the hair growth rate.

Accordingly, one embodiment of the invention provides a composition for hair regeneration that includes as an active ingredient certain extracts from thymosin. Specifically, an extract called thymosin fragment 5. The hair regeneration composition may also include other components, such as a mitocide or bioflavanoid. Below, each of the components is described in more detail.

Thymosin Fraction 5

Thymosin fraction 5, (TF5), is a mixture of partially purified polypeptides prepared by calf thymus. TF5 is routinely made from calf thymus. It can also be made from thymus tissue of porcine, ovine and murine species, as well as goat, rat, chicken and human. The preparation and isolation of TF5 has been described by Hooper in The purification of bovine thymosin, Ann. NY Acad Sci. 249:125, 1975). The FIGURE shows a representative purification method. TF5 is composed of 40-50 distinct polypeptides, which are concentrating on polyacrylamide gel plate (pH 3.5-7.9). TF5 is free of endotoxins, carbohydrates, and lipids. TF5 was shown to restore immune function in thymic or immunodeficient animals, humans with primary immunodeficiencies and immunosuppressed patients. This mixture of peptides has a primary effect on cell-mediated immune system.

Low, “The Chemistry and Biology of Thymosin I” (Low) state that thymosin (T?) is an immunomodulatory 28 amino acid peptide (molecular mass 3,108 daltons). “Isolation, characterization and biological activity of T?1 peptide and polypeptide?1 from the calf thymus”, J. Bio. Chem. Chem. Chem. 257:1000, 1982). T?1-T?4 are highly preserved in nature, and their amino acids sequences are the same in most mammalian species. More than a dozen TF5 like preparations were prepared from calf and porcine thymus tissues. The thymic extracts thymostimulin(TP-1), TFX thymalin thymoject thymovocal and others are variations of TF5 formulation. They are all partially-purified preparations containing mainly polypeptide mixtures of molecular weights less than 15,000. T1 and T4 are the major biologically active components in TF5. Other thymosins peptides, such as T2 to T11 and T3 and T4 at lower concentrations can also be found. T?13 to T?13. MB3S and MB40. Ubiquitin. Thymulin (FTS), the thymic humoral (THF?)2 factor, and thymopoietin. The TF5 extracts that are prepared using variations of the original procedure to prepare TF5 can also contain? The TF5-like extracts prepared by variations of the procedure used to prepare TF5 may also contain? “As key ingredients, and smaller amounts of other peptides such as Pro T?3, THF?2, TP and MB35 and MB40.

The present invention covers TF5 as well as all TF5 like thymic extracts containing T?1 or T?4. T?1 or T?4 are characterized by their ability, among other things, to regulate and stimulate cell-mediated immunity and enhance wound healing. They also have the ability to increase resistance against microbial infections, as well as to decrease microbial adhesion (Baumann, et. al., “Preclinical Studies of Thymosin?1 and Thymosin?4”, In: Mauer H. R. Goldstein A. L. Hager E. D.,Thymic 13-17, 1977). As used in this application, the terms TF5 and TF5-like refer to only those thymic extractions that contain T?1 or T?4. The presence of T1 or T4 is required in TF5 or TFS-like formulations. Other peptides can be present at some concentration, but the concentration should range from 0.05-0.1% by weight.

The first studies on immunosuppressed mice (Oates, K. Goldstein, A. L. Thymosin) suggested the importance of TF5 and TF5-like products in preventing infection in immunocompromised individuals. In: De Vita, D. T. Hellman, S., Rosenberg, S. A. (eds. (eds. Goldstein, A. L. “Clinical Applications of Thymosin Alpha-1” Cancer Invest. 12:545-547, 1994). Early studies showed that immunosuppressed mice were more likely to survive infections with BCO or Candida or Cryptococcus if they were treated with T?1 or similar preparations. Immun. 23:330; Bistoni and al., “Increase of mouse resistant to Candida albicans infections by Thymosin A 1” Infect. Immun. 36(2):609-614, 1982). In mice with T-cells depleted, TF5 was found to restore Blastomyces dermatitis immunity (Longley R. E., and Cozad G. C. “Thymosin Restoration of Cellular Immunity to Blastomyces Dermatitidis in T.-cell Depleted Mice”, Infect. Immun. 26(1):187-92, 1979). In studies of the same type, cell-mediated immunity against Listeria monocytogenes in mice malnourished with protein was increased following treatment with TF5. In mice infected by Newcastle disease virus, the administration of T?1 or TF5 also increased the production of interferon. 1:411, 1981). In studies on mice, injections of TF5 and Toc1 increased resistance to Candida albicans infections (Bistoni et. al., “Increase of Mouse Resistance to Candida Albicans Infection by Thymosin a 1” Infect. Immun. 36(2):609-614 1982; Salvin S. B. & Neta R., “Resistance to infection and susceptibility in inbred murine strains. I. Cell Immunol. 75:160, 1983. The increased resistance against infection after TF5 administration has been attributed by some to an increase in specific cytokines, such as MIF or IFN. I. Cell Immunol. 75:160, 1983). Injection of TF5 and T?1 has also been shown to protect 5-fluorouracil (5FU)- or morphine-immunosuppressed mice against opportunistic infections with C. albicans, Listeria monocytogenes, Pseudomonas aeruginosa, and Serratia marescens (Ishitsuka et al., \”Protective activity of thymosin against opportunistic infections in animal models,\” Cancer Immunol. Immunother. Immunother. Ex. Immuno. 97:347-352, 1994). T?1 in combination with amantadine, an antiviral drug, and interferon has also been shown to be effective in mice infected by influenza virus. This new combination protocol was found to increase long-term survival, reduce viral titers, and restore a number immunological parameters such as natural killer cells activity, cytotoxic t-lymphocyte response, and subsets CD4+/CD8+. IFN in mice infected by influenza A virus. Int. J. Immunopharmacol. 18:95-102, 1996).

Clinical studies on humans have shown that thymic factor treatment can reduce the duration of viral infections, such as herpes zoster and herpes labialis, and also adenoviruses, hepatitis and cytomegaloviruses. (Ajiuti, A placebo-controlled trial of thymic hormonal treatment of recurrent Herpes Simplex Labialis in immunodeficient hosts: Results after 1 year follow-up,” Immunol. Immunopathol. Businco, L. & Rezza, E. “Therapy for viral disease in immunesuppressed patients using TP-1” Thymic hormones and T lymphocytes, (A. F. Wigzel ed. Academic Press, New York. p. 295. Demartino and colleagues, “T-lymphocytes of children with respiratory infections. Effect of thymostimulin use on the alteration in T-cell subsets” International Journal of Tissue Reaction. J. Tissue React. J. Tissue React. Churchill Livingstone Edinburgh, Churchill Livingstone Thompson and N. R. Rose, editors. ), Elsevier Biomedical, New York, p. 295, 1981). These studies suggest that TF5 preparations or TF5-like products may be helpful in preventing or reducing infections in immunocompromised host.

TF5 or TF5-like products have been used in clinical trials for patients with primary and second immunodeficiency. This category includes a number of syndromes relating to congenital immune system defects. This may include defects in T-cells, B-cells or both lymphocyte populations. The number and percentage of Erosette-forming cell in vitro has increased after incubation of TF5 or TF5-like preparations (Schulof R. S., Goldstein A. L. “Clinical Applications of Thymosin and Other Thymic Hormones” in Recent Advances in Clinical Immunology, R. A. Thompson, N. R. Rose (eds. Churchill Livingstone Edinburgh, p.243, 1983).

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