Out-licensing

Hexabrix, the contrast material used in the study thus far, has also proven to be effective for atopic dermatitis/eczema in a mouse model and for allergic conjunctivitis in a rat model.

The contrast media used for injection for x-ray use has been shown to have anti-allergy properties. When applied to the skin topically and in enough concentration the media has the ability to inhibit antibody-antigen reactions and any enzymatic reaction. When tested in humans Hexabrix was more effective than placebo in all tested parameters.Particularly significant differences were found in " sneezing "and " runny nose " two of the most bothersome symptoms associated with allergies.

A license is now being offered for the drug at a significantly low price. Please see below for further details of the benefits of this unique and efficient drug:

1. The product is distinctly unique, there is no other small molecule that will do what this product will for allergic rhinitis. This product offers more that anything in the pipeline (ie H1 antagonists, corticosteroids, allergans inducing an immune response, and monoclonal antibodies to suppress IgE.)

2. In 2009 the global allergic rhinitis market was worth $7bn and had an annual growth rate of 10%. Market research says that current drugs take 8 hours or more to induce a response and says that ‘Any new drug with better response rates will capture value in the market' This drug has an almost immediate effect on the symptoms and signs of allergic rhinitis.

3. Problems with current intranasal allergy drugs: Steroids effective bur takes days and still necessitates antihistamines. Montelukast (leukotriene) inhibitor is only modestly effective and is believed to be having problems in some countries. 4% NA cromolyn did not differ from placebo in a 32 patient trial. Decongestive drugs can cause ‘rebound effects'.

4. In a survey of 2500 adults the following adverse effects for drugs being used in allergic rhinitis were noted: drying feeling 47%, dripping in throat 41%, drowsiness 37%, bad taste 32%, burning 17% and headache 16%. In our 20 person clinical trial there were no adverse effects nor were there any in about 150 anecdotal trials. This makes the material more likely to be acceptable for children's allergies. Furthermore although the company have not yet tested it, the material should be amenable to inhalation therapy in the treatment of asthma.

5. The material is the x-ray contrast medium called ‘Hexabrix (ioxoglate) It is off-patent some years ago. We now wish to switch to another C.M (Visipaque) Any other contrast material now on the market or in development will also be satisfactory. The patents cover all current x-ray contrast media on the market and cover media on the market and cover all triiodinated benzene ring products (current or potential) It is the triiodinated benzene ring that accounts for the success of our product. This product acts on the IgE in the area of topical application to inhibit the mast cell that when stimulated to release their products constitute the linchpin events in allergy. No similar product on the market has a full and detailed explanation.

6. As the product attaches to the Fc (constant) portion of immunoglobins rather than to the Fab (variable) portion, the potential to use topical application of the product for many other situations where mast cells play a prominent role is there. There is good preliminary data for example that might serve well in eczema/atopic dermatitis. Xolair, the injectable drug for asthma is a monoclonal anti-IgE drug that costs a huge amount of money and takes months to kick in. It is a very large molecule and while it might have an ultimate effect on allergic rhinitis, practical considerations in terms of expense, immediacy of action and safety put the products in a different and more favourable position.

 

Early Stage

The company have 3 issued US patents, 1 US patent pending, 1 issued European Patent and 1 issued Japanese patent.

We seek to out-partner with a company that can carry our allergic rhinitis project to completion and would then sell to a major pharma or would market our drug themselves. We would seek a nominal up-front payment and a share in royalties.

Alternatively an out-partner might wish to buy our entire patent rights and then would have the right to exploit the antigen- antibody inhibition and the general enzyme inhibition that can be used in many ways besides general allergy.