There are multiple types of skin disorders that could cause anyone concerned about cancer to wonder about a spot on their skin or on a loved one’s skin. This fear of having cancer is not unfounded as the incidence of skin cancer is increasing at an alarming rate due in large part by ultraviolet (UV) exposure either over time or to excessive sun burn. Rubigo Therapeutics is a development stage biotech company focused on developing a technology using an active polymeric material that offers a topically controlled release of small molecules targeted at tissue lesions suspected of being cancerous and longer term, a therapeutic delivery platform.
Although melanoma is the fifth leading cause of death associated with cancer in men and seventh for women, ahead of ovarian, identifying these types of lesions are not always as easy as everyone would like. Additionally, even squamous-cell carcinoma, which is typically perceived as benign, can become lethal if not addressed early enough. Early confirmatory feedback that an odd looking mole or lesion is cancerous can be of tremendous value to patients, physicians and healthcare payers to either objectively dismiss a concern or plan an appropriate, timely course of action.
The list of possible market opportunities and possible drug candidates that could be combined with Rubigo Therapeutics’ unique technology is substantial; however, the company has elected to focus its development efforts in skin cancer involving Imiquimod, an immune response modifier, due to a number of competitive factors.
Imiquimod, which was developed and patented by 3M in the early 90’s and FDA approved in 2006 for genital warts, and subsequently for actinic keratosis and basal cell cancer, has shown clinical effectiveness to the FDA, prescribing physicians and healthcare payers. This has occurred over the past five years despite a broad array of topical delivery issues, questions involving dosing and adverse effects in patients. Due to Rubigo Therapeutics’ unique polymer construction, Imiquimod can be easily and consistently loaded and more importantly, delivered in a consistent and reliable fashion transdermally into the patient’s skin where needed. Early in vitro data suggests this can be done with lower concentrations of the active drug, providing additional control and means to control dosing of the therapeutic molecule than is currently offered by creams. The company believes that its substantially improved means of delivering a highly effective, market recognized therapeutic molecule for the treatment of skin cancer, both for early assessment and treatment which is protected by fresh intellectual property, makes Rubigo Therapeutics a novel technology entrant in a large, growing worldwide market.
In terms of treatment, all forms of skin cancer can be successfully treated surgically. From the perspective of healthcare payers such as the Center for Medicaid and Medicare Services (“CMS”) or Private Payer, management of skin cancers are costly and will continue to be costly unless earlier diagnosis and treatment can occur. Today, non-melanoma and melanoma disorders are estimated to cost as much as $1B and $1.9B per year respectively in the U.S. Consequently, the need to accelerate earlier assessment of potentially deadly and yet, treatable skin lesions is a very compelling need. This need is further enhanced when one can improve the information being discussed and utilized between patient and physician to achieve the best clinical outcomes and minimizing surprises and patient dissatisfaction regarding the loss of tissue or worse yet, becoming disfigured. Rubigo Therapeutics will be a presenting company at OneMedForum NY 2011 June 22-24.
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