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DEVELOPMENT
| First Application: Fenretinide |
Retinoids are a class of structural Vitamin A analogs that influence cellular proliferation and differentiation, while exhibiting broad chemo-preventive activity in carcinogenesis models. Retinoic acids and retinols are soluble compounds that serve as the active ingredient in several parenteral products on the market. In contrast, neutral (uncharged) retinoids are poorly soluble and current dosage forms are unable to achieve adequate systemic exposure following oral or parenteral administration. The limited options for administration of these novel retinoids are major impediments in realizing their therapeutic potential.
The first neutral retinoid application for this novel drug delivery system is a promising cancer prevention agent, called fenretinide, which was created and developed by Johnson & Johnson (J & J). Upon discontinuation of development, J & J transferred fenretinide to the United States National Cancer Institute (NCI) where it was tested as an oral application in the treatment of various cancer indications. The results, flowing from these human clinical trials, have highlighted the potential of this agent in the treatment of a number of cancer indications. Unfortunately, this potential has never been fully realized since existing pharmaceutical technology has depended on utilizing orally dosed formulations that were incapable of achieving effective drug levels due to the insoluble and non-absorption nature of the compound.
In solving this problem by creating an intravenous version of fenretinide, the drug can be delivered in dosage levels shown to produce internal concentrations that induce cell death without additional toxic or allergic effects due to vehicle excipients, toxic substances used in traditional IV drug formulations. Moreover, SciTech envisions creating a product that can deliver combination drug therapies and/or target that delivery to specific organs, such as the pancreas, by utilizing this advanced technology.
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| Products |
- Fenretinide Chemotherapy Intravenous (IV) Treatment (Lead Product). Fenretinide has been tested for over 25 years and has proven to be effective in treating and preventing cancers. SciTech has combined its nanoparticle drug-delivery platform with fenretinide as a promising approach to realize increased clinical benefit in these cancers as well as possible new indications such as pancreatic cancer. SciTech has partnered with Campbell University's (North Carolina) department of Pharmaceutical Sciences to develop this scale-up formula which will be used for mass-reproduction in a manufacturing environment. SciTech plans to batch manufacture this fenretinide product for proof of concept clinical studies in 2008 and combined Phase I/II Clinical Trials in 2009.
- Fenretinide Topical Chemotherapy (First Product). Cancerous and pre-cancerous skin lesions result from excessive exposure to UV irradiation from the sun. One of the leading abnormalities, Actinic Keratosis (AK) is a pervasive and serious pre-cancerous condition capable of leading to basal (BCC) and squamous cell carcinoma (SCC). In the United States, SCC is the second most common form of skin cancer, afflicting 200,000 people per year. SciTech has created a second unique fenretinide product for topical delivery in the treatment of various precancerous/cancerous lesions of the skin. SciTech’s topical drug product is better tolerated and more efficacious than products currently available on the market.
- Expanded Product Line. After proving the viability of its fenretinide treatment for one cancer indication, to be chosen during Phase I trials, SciTech will test (or license) fenretinide for up to seven other cancer applications. SciTech will also employ its delivery system with other types of neutral retinoids and other investigational agents for acute medical conditions in order to develop a portfolio of product applications.
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