Abstract
| Grant Number: | 5R44CA099307-03 |
| Project Title: | DermX: Topical Protector Against Radiation Dermatitis |
Abstract: Numerous clinical studies have described the negative impact of radiotherapy-induced dermatitis on cancer patients during and after their 5-6 week course of radiotherapy. Virtually all patients develop at least a mild dermatitis, and for almost half it's a painful side effect lasting weeks. There can be scarring, limitations on more aggressive radiotherapy, and can result in patients quitting radiotherapy, with a significant effect upon tumor recurrence. There are no products on the market that prevent or treat this dermatitis.
ProCertus, an early-stage biotech company, has developed a topically-applied small molecule drug for a product, DermX, that confers complete protection against the Grade 1->4 dermatitis seen in a rodent radiodermatitis model, a model that closely reflects the human experience. Based upon market analysis, ProCertus has concluded that a topical preventive for radiodermatitis would be well-received by cancer patients, and yield annual revenues in the range of $250 million. A DermX product would reduce radiotherapy-associated pain, could potentially enable more aggressive radiotherapy where dermatitis is dose-limiting,
and could reduce the drop-out rate late in radiotherapy courses. Phase II funds will enable us to
address the key, remaining issues in DermX scientific development, which are: i) ensure that topicallyapplied DermX does not affect external beam radiation killing of tumor cell xenografts in nude mice, ii) optimize a topical delivery vehicle that enables full radioprotection of skin stem cells while allowing insignificant levels of DermX active agent to enter systemic circulation, and iii) complete cGMP-certified batch synthesis of DermX that is required for studies prior to filing for its Investigational New Drug (IND) status.
At the end of this Phase II project, ProCertus envisions a DermX product ready for clinical trials that: i) is a topical solution devoid of systemic side effects, ii) is applied 1-2 times in the 30 min before radiotherapy, and iii) is expected to prevent the Grade 1-4 dermatitis normally experienced by radiotherapy patients.
Thesaurus Terms:
drug design /synthesis /production, pharmacokinetics, radioprotective agent, topical drug application
chemoprevention, cytoprotection, drug screening /evaluation, neoplasm /cancer radiation therapy, nonhuman therapy evaluation, polyamine, therapy adverse effect
athymic mouse, laboratory rat, miniature swine
| Institution: | PROCERTUS BIOPHARM, INC. |
| SUITE 175B |
| MADISON, WI 53719 |
| Fiscal Year: | 2006 |
| Department: | |
| Project Start: | 13-AUG-2003 |
| Project End: | 31-MAY-2008 |
| ICD: | NATIONAL CANCER INSTITUTE |
| IRG: | ZRG1 |
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