>>SLOUGH, U.K., Jan. 10, 2005 (PRIMEZONE) -- Xenova Group plc (NasdaqNM:XNVA - News) (London:XEN.L - News) today announced that it has entered into a licensing agreement with Cancer Research Technology Limited (CRT) in respect of Xenova's intellectual property relating to TA-CIN. TA-CIN is a vaccine developed by Xenova as a treatment for women with cervical dysplasia, and has proved safe and immunogenic in Phase I and Phase II clinical trials.
CRT will facilitate a further Phase II clinical trial to be undertaken at St. Mary's Hospital Manchester and associated laboratory studies at the Paterson Institute for Cancer Research in Manchester to evaluate TA-CIN in combination with an immune modulator in subjects with vulval intra-epithelial neoplasia (VIN). This trial, expected to start shortly, will recruit between 20 and 30 women with known, pre-treated, or newly diagnosed VIN3. The primary end point is objective response of vulval intraepithelial lesions to treatment as well as evaluating safety, toxicity and tolerability of the combination treatment.
CRT will license TA-CIN patents, know-how and materials from Xenova and will undertake marketing of TA-CIN to potential commercial partners with a view to sub-licensing the development and commercialisation of the product. Net receipts from the sub-licensing of TA-CIN will be shared between Xenova and CRT after certain direct costs have been recouped.
Cervical dysplasia (also known as cervical intra-epithelial neoplasia, CIN) is one of a group of conditions, including VIN, known collectively as ano-genital intraepithelial neoplasia (AGIN), which are precursors to invasive cancers such as cervical cancer. Infection with certain high risk types of Human Papillomavirus such as HPV16, is closely associated with these dysplasias and cancers, which are difficult to treat and have a high recurrence rate.
David Oxlade, Chief Executive Officer of Xenova said: ``We are delighted that the promising TA-CIN vaccine is now progressing into further Phase II studies through this relationship with CRT. This collaboration provides further evidence of the potential value of Xenova's portfolio of novel cancer drugs.''
Dr. Keith Blundy, Chief Operating Officer of CRT stated: ``We are pleased to in-license and develop this opportunity from Xenova, which clearly demonstrates CRT's strategy for expanding our oncology portfolio and addressing our goal of cancer patient benefit.''
Notes to Editors
TA-CIN is a subunit vaccine comprising L2/E6/E7 proteins from Human Papillomavirus (HPV16), designed to generate a strong cellular immune response against HPV-infected cells. The vaccine is targeted at patients with cervical dysplasia (pre-invasive cervical disease), thus potentially preventing the onset of invasive cervical cancer. The initial product candidate for clinical trials is a genetically engineered fusion of three proteins from HPV 16 known to play a role in the progression of cervical disease. Published data have reported that tumour cells in more than 90 percent of patients with cervical cancer contain DNA from the HPV virus, specifically types 16 and 18.
Human papillomavirus (HPV) is a large family of small DNA viruses associated with a number of conditions ranging from skin warts and genital warts to cervical cancer. Infection with high risk types of HPV (such as HPV16 and HPV18) is strongly associated with ano-genital cancer and its precursor AGIN. These diseases are difficult to treat and have a high recurrence rate.
The successful results of a Phase I safety and immunogenicity study for TA-CIN were presented at the 19th International Human Papillomavirus Conference (September 2001). In this placebo-controlled, dose-escalating study, the vaccine was administered by intramuscular injection to 40 healthy volunteers. TA-CIN was found to be well tolerated. No serious adverse events were reported during the study. The vaccine was also found to be immunogenic. TA-CIN specific antibody responses, and positive T cell responses were seen in all of the cohorts receiving active vaccine.
In addition, TA-CIN has been evaluated in a prime boost strategy, in combination with TA-HPV. Pre-clinical studies, conducted by Xenova in conjunction with scientists at Leiden University Medical Centre, The Netherlands, demonstrated that use of TA-CIN together with TA-HPV, resulted in an immune response that was significantly greater than that observed with either product alone. In a subsequent Phase II prime boost clinical trial conducted at St. Mary's Hospital Manchester and the Paterson Institute for Cancer Research in Manchester, both products proved safe and well tolerated, and some clear clinical responses were demonstrated, even in women with long-standing disease.
Xenova originally licensed the rights to an L2 patent from CRT but returned these rights in early 2004 following the rationalisation of Xenova's patent portfolio following the acquisition of KS Biomedix Holdings plc.
TA-HPV is an immunotherapeutic vaccine developed for use alongside surgery in the treatment of cervical cancer and for the treatment of high-grade AGIN.<<
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On another subject, XNVA is on the Reg. SHO threshold securities list, FWIW.
Cheers, Tuck |
