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[BioSpecialist]

Gene-based Brain Cancer Drug --P3 results in July

This stock is significantly undervalued ...

Ark therapeutics (AKT.L)

Marketcap: 143 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 70p

Pipeline:
http://www.arktherapeutics.com/main/research_development.php?content=product_portfolio
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Cerepro (malignant glioma) final Phase III results in July 08
about Cerepro
http://www.arktherapeutics.com/main/products.php?content=products_cerepro

Trinam (haemodialysis access) start Phase III in 1H 08
about Trinam
http://www.arktherapeutics.com/main/products.php?content=products_trinam

Vitor (cachexia) start Phase III in 1H 08
about Vitor
http://www.arktherapeutics.com/main/products.php?content=products_vitor
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Exciting times for Ark Therapeutics

Created:11 March 2008
Written by:Richard Hemming

The much anticipated data for Ark Therapeutics’ brain cancer drug, Cerepro, is due at the end of July and chief executive Nigel Parker knows what is at stake: “Once we get an approval of Cerepro the future of this company is assured.”

Nomura Code analyst Samir Devani puts the likelihood of success of the Phase III trial at 50 per cent. A failure would see a 50 per cent fall in the share price, but success is likely to see the share price north of 200p, he says.
Ark raised over £35.4m in a placing and open offer at 105p a share last November, and the company is building up a stronger early and late stage pipeline. But investors’ confidence will be increased by Dr Parker’s belief that the compelling results for Cerepro seen in Phase II - versus patients on standard treatment - will occur again in the bigger Phase III trials.

Elsewhere, Trinam, a treatment for blood vessel blockages in dialysis patients and Vitor, for cancer-related muscle wastage, are both entering Phase III trials this half.

Nomura Code expects a loss per share of 10.9p in 2008 and has a fair value of 130-140p on the shares.
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Gene therapy for high-grade glioma with an adenoviral vector containing the Herpes Simplex virus thymidine kinase gene (Cerepro™): From pre clinical studies to a randomised phase II survival study

Objective
The aim of these studies was to evaluate the efficacy and safety of CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with intravenous Ganciclovir in pre clinical animal model as in patients with operable high grade glioma. Our randomised, controlled, phase II study involved 36 patients with operable primary or recurrent high-grade glioma.

Methods
Patients were randomised in phase II study either to receive CereproTM (3x1010 pfu) by local injection into the walls of the tumor cavity at the time of tumour resection, followed by intravenous ganciclovir, 5mg/kg twice daily for 14 days (n=17) or standard care consisting of radical excision (n=19). Patients in both groups with primary tumours received postoperative radiotherapy.

Results
In the phase II study, there was an increased mean survival from 39.0±19.7 (SD) in control group to 70.652.9 weeks in the treatment group (p=0.0095) following CereproTM therapy. Median survival increased from 37.7 to 62.4 weeks. The percentage increase in mean survival was 81% and median survival was 65%. This therapy was well tolerated according to adverse events, clinical chemistry, haematology and immunology. There was no evidence of any deterioration in quality of life or increased use of concomitant medications.

Conclusions
CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with ganciclovir is a novel, safe, promising therapy for operable malignant glioma.



Presentations (please read the March 2008 presentation)
http://investors.arktherapeutics.com/presentations


More Infos
http://www.iii.co.uk/investment/detail?code=cotn:AKT.L&display=news&it=le