Positive Mycograb trial results for the treatment of Candidiasis not so long ago (20th April 06) :
Full report Link :
http://www.investegate.co.uk/Article.aspx?id=200604200700527151B
Conclusions as follows:
Conclusion:
The conclusion of the paper is that "Mycograb(R) plus lipid-associated
amphotericin B produced significant clinical and culture-confirmed improvement
in outcome for patients with invasive candidiasis."
Mycograb(R) is the subject of a Common Technical Document ("CTD") for market
authorisation submitted to the EMEA in March 2005. Progress to date remains
consistent with a market launch by the end of 2006.
Prof. Arturo Casadevall from the Albert Einstein College of Medicine, New York,
said:
"Candidiasis is associated with an unacceptably high mortality rate even when
treated with antifungal drugs. Prof. Pachl's report shows that the
administration of Mycograb(R) in combination with amphotericin B to patients
with invasive candidiasis reduced candida-attributable mortality over 4-fold,
markedly improved the overall response, and increased the rate of
culture-confirmed clearance of Candida species, compared with the administration
of amphotericin B alone. This could hasten the arrival of the third-age of
antimicrobial therapy."
Prof. James Burnie, Chief Executive of NeuTec, commented:
"We are delighted that Mycograb(R) has generated so much interest and that now
the results of the pivotal trial have been published in a prestigious journal in
the field of infectious diseases. We believe that Mycograb(R) represents a new
era in the treatment of life-threatening infections. This drug reduces the
mortality of an infection which kills around 1 in 5 patients on standard
antifungal therapy. Mycograb is currently being given under a compassionate use
programme, in which it has been used in combination with either amphotericin B
or caspofungin."
Other indications:
NeuTec recently reported that patient recruitment was completed in a phase Ib
study to evaluate the safety and efficacy of Mycograb(R) in combination with
Docetaxel in metastatic or recurrent breast cancer patients. We also recently
reported that an IND in the US has been obtained for a double-blind,
placebo-controlled, multi-centre phase III study using Mycograb(R) in
combination with generic amphotericin B and 5-flucytosine against Cryptococcus
neoformans - a cause of mortality in HIV infected patients. Hospitals in the
US, South Africa and South America have agreed to take part in the study which
will commence shortly.