Dermos^TM

Aphios Corporation has developed Dermos™ as a topical treatment for AIDS associated Kaposi’s sarcoma (AIDS-KS) and other skin cancers as well as proliferative diseases of the skin utilizing a nanosomal formulation of a potent anticancer drug [U.S. Patent Pending, 2003].

Nanosomes™ are small, uniform liposomes that are less than one nanometer in diameter. Liposomes are microscopic vesicles of phospholipid bilayers comprised of single or multiple lipid bilayers. Liposomal formulations of daunorubicin and doxorubicin have been approved by the FDA for first-line and second-line systemic treatment of AIDS-KS. Paclitaxel, a unique anti-mitotic agent, has been approved by the FDA for systemic application in metastatic cases of breast cancer and refractory cases of ovarian cancer, and AIDS associated Kaposi’s sarcoma. These three drugs, while being very effective, are burdened by systemic toxicities such as neutropenia, myelosuppression, alopecia, nausea and vomiting.

A topical formulation of an antineoplastic drug that is effective against visual and sub-cutaneous Kaposi’s sarcoma will reduce the systemic use of these drugs, minimizing blood toxicity levels and improving a patient’s quality of life. Nanosomes are ideal vehicles for the topical delivery of antineoplastic agents.

Aphios developed Dermos™ for the treatment of AIDS-KS by: (1) comparing the deposition of paclitaxel into and across hairless mouse skin following in vitro and in vivo topical application of various formulations; (2) validating the use of in vitro diffusion experiments to predict in vivo deposition behavior; (3) comparing the kinetics of uptake into and across hairless mouse skin following topical in vivo application of various formulations; (4) evaluating the effects of formulation composition on the deposition of these agents in hairless mouse skin; and (5) in vivo evaluation of best topical preparation against KS Y-1 tumors induced in nude mice.

To characterize the early steps accompanying apoptosis, KS cells were monitored by 3D epifluorescence confocal microscopy 48 hrs after treatment with the topical preparation. Cells treated with PBS showed defined normal nucleoli. In contrast, KS Y-1 cells treated with the topical formulation exhibited overall induced reduction in cell size as well as diffuse staining and clumping of chromatin which is consistent with apoptosis.

The Dermos™ formulation with other active ingredients will also find utility in melanoma, other types of skin cancers and proliferative diseases of the skin such as alopecia.

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