Agreement to Develop Rapid Diagnostic Test for Nasopharyngeal Cancer
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Agreement to Develop Rapid Diagnostic Test for Nasopharyngeal Cancer

LONDON—Dec. 12, 1996 -- Cortecs International ("Cortecs") (NASDAQ:DLVRY/LSE:COR/ASX:CRI) the U.K. based pharmaceutical company, has signed an exclusive agreement with Cancer Research Campaign Technology Limited ("CRCT") for the development of diagnostic tests for nasopharyngeal cancer ("NPC").

Cortecs plans to initiate a program aimed at developing and commercializing a series of diagnostic products, using whole blood, plasma, serum or saliva, suitable to assist in diagnosing NPC.

This agreement furthers the Company's strategy, implemented following last Summer's successful capital raising, to increase shareholder value by exploiting its platform technologies. At its AGM, the Company advised shareholders that it was negotiating for two additional antigens to expand the range of diseases addressed by its rapid point-of-care diagnostic technology. On November 25, 1996 the Company announced the first of these, an antigen to enable detection and early diagnosis of tuberculosis.

New antigens developed by third parties which are offered to the Company for incorporation with Cortecs' rapid point-of-care diagnostics technology, such as NCP and tuberculosis, can provide Cortecs with commercial opportunities of significant potential at very low risk and cost. The Company has demonstrated that these rapid point-of-care products are of interest to major international pharmaceutical groups for sales and distribution. Cortecs will seek such collaborations for the products resulting from the new antigen agreements.

The Agreement

CRCT will provide access to CRC funded work by Dr. John Arrand at the Paterson Institute of Cancer Research, Manchester, U.K. This work has produced reagents and antigens which have been demonstrated to be useful in diagnosing NPC. Cortecs will combine this know how and technology with its own ELISA and rapid point-of-care technologies used in its Helisal range of products. An ELISA test will be designed for use in hospitals and laboratories in diagnostic screening procedures. The rapid point-of-care tests are planned to be small, self contained and capable of being used without the need for special training or personnel or any additional apparatus and therefore may be useful for testing "at risk" populations.

Commenting on the announcement, Dr. Michael Flynn, President of Cortecs and Chief Scientific Officer, said: "NPC patients show an abnormal response to Epstein-Barr Virus ("EBV") infection. CRCT have developed technology which may make it possible to identify patients showing this response. CRCT and Cortecs' combined technologies could enable screening and rapid screening systems to be put in place in countries where the populations are most at risk. An ELISA and a rapid point-of-care diagnostic could be extremely useful for earlier detection of nasopharyngeal cancer and therefore allow early medical intervention."

Dr. Susan Foden, Managing Director of CRCT, said: "We are pleased to see exciting research funded by CRC being taken on for development by Cortecs. The work by Dr. John Arrand should give Cortecs a good start in developing urgently needed tests for early diagnosis for NPC. It is good to see CRCT expediting rapid progress from bench research to diagnosis in the field by way of this collaboration."

Nasopharyngeal Cancer

There is much evidence to support an association between infection with Epstein-Barr Virus ("EBV") and NPC and the immune response of patients with NPC to EBV is diagnostic of the tumor.

In certain Chinese populations (southern provinces of China, Hong Kong, Taiwan, Singapore and Malaysia) the incidence is 15 - 30 per 100,000 per year. In these populations it is the most common tumor among men and the second most common among women and it is estimated that annual incidence could be as high as half a million. There is also evidence of high mortality associated with the disorder among black American men age 60-80 years old. However, in most countries NPC is rare with rates of less than 1 per 100,000 per year.

In 1982, the International Union Against Cancer recommended that "screening programs and reliable test systems for the early detection of individuals at risk by immunological and biomedical surveys should be extended as a high priority". It is estimated that the population at risk in China, Hong Kong, Taiwan, Singapore, South Korea, Malaysia, Indonesia, Thailand, the Philippines and Vietnam totals almost 1.7 billion people.

Parties to the Agreement

Cancer Research Campaign Technology is the technology transfer subsidiary of the Cancer Research Campaign and was established in 1987 to develop the fruits of Campaign-funded research to benefit the public worldwide. CRCT seeks discoveries resulting from the Campaign's research portfolio and develops and exploits these in partnerships with biotechnology and pharmaceutical companies on an international basis. All profits from the Company's activities are plugged back into the Campaign's vital program of cancer research.

Cortecs International

Cortecs International is a British-based company quoted on the London Stock Exchange, the Australian Stock Exchange and on Nasdaq. The Company specializes in the development of new oral pharmaceutical delivery systems, new oral mucosal vaccines and point-of-care rapid diagnostics which provide the opportunity to advance the management of serious diseases such as:

OSTEOPOROSIS

Oral Calcitonin - an oral therapy for the prevention of bone breakdown. In Phase II/III.

Osteosal - a rapid doctors' office test in collaboration with Osteometer to detect increased bone breakdown indicating the risk of the disease osteoporosis and also to monitor the adequacy of therapy. In development.

HELICOBACTER PYLORI

Helisal - a rapid doctors' office whole blood test for the detection of H. pylori. In the market. A rapid saliva test. In development. A 'one-step' whole blood test for the detection of H. pylori. In development.

Oral Therapeutic Vaccine - in development to stimulate immunity. Oral Therapeutic - in research to improve eradication results.

DIABETES

Glycosal - three rapid doctors' office tests in collaboration with Exocell to assist in the management and identification of diabetes. In development.

Oral Insulin - In Phase I trials.

Neurulin - a topical product to treat diabetic neuropathy. In Phase II testing.

CYSTIC FIBROSIS & CHRONIC BRONCHITIS

Pseudostat - an oral therapeutic antigen to treat and prevent lung infection with Pseudomonas aeruginosa now in Phase II trials.

Flustat - an oral vaccine against influenza entered Phase I trials.

TUBERCULOSIS

Diagnostics - ELISA tests to provide hospitals and laboratories with serodiagnostic procedures. In development. Rapid point-of-care, self-contained diagnostic kits, designed for use without any special training. In development.

THRUSH

Moniliastat - an oral therapeutic vaccine against vaginal thrush. Enters human trials in current financial year.

MALE HORMONE DEFICIENCY

Halo Testosterone - an oral male hormone replacement therapy in development to treat male hypogonadism. In development.

Cortecs also markets a range of ethical and OTC medicines and diagnostic products.

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