Clinical Trials Update

RNS Number:9809C
Phoqus Group plc
30 August 2007

     Phoqus receives IND from FDA and initiates Phase II clinical trial of
Chronocort(TM)in patients with Congenital Adrenal Hyperplasia at the US National
                              Institutes of Health



West Malling, UK, 30th August 2007: Phoqus Group plc (AIM: PQS) ("Phoqus"), the
drug development company, today announces that it has initiated a Phase II
clinical trial at the US National Institutes of Health ("NIH") for its lead
product Chronocort(TM) in patients with Congenital Adrenal Hyperplasia ("CAH").



CAH, due to 21-hydroxylase enzyme deficiency, is a disease of the adrenal cortex
characterized by cortisol deficiency (with or without aldosterone deficiency)
and androgen excess. Current conventional therapy consists of hormone
replacement with a form of glucocorticoid (such as hydrocortisone), which is
often suboptimal and many unresolved clinical problems exist. Chronocort(TM) is
a newly-developed, slow-release formulation of hydrocortisone that mimics the
normal cortisol circadian rhythm, potentially providing improved clinical
outcomes of treatment.



The trial (Phoqus Study #004) is a Phase II, open-label, crossover study to
compare the steady state serum concentration profiles and pharmacodynamic
responses to Chronocort(TM) tablets (once daily) with Cortef(TM) immediate
release hydrocortisone tablets (three times daily) in the treatment of patients
with a diagnosis of CAH. 12 eligible male and female patients will receive a
minimum of 7 days of Cortef(TM) three times daily followed by approximately 28
+/- 3 days of Chronocort(TM) once daily. As such, the trial is designed to
establish clinical proof of concept for Chronocort(TM), the potentially first-
in-class circadian corticosteroid therapy, in CAH.  Chronocort(TM) has been
granted an IND by the US Food and Drug Administration ("FDA") and the study has
been reviewed by the NIH Institutional Review Board ("IRB"). Patient
identification is now underway, with first patient dosing expected in the next
few weeks. The results of Study #004 are expected to be available by the end of
November 2007.



The primary objectives of the trial are to: (1) compare the multiple dose
(steady state) serum cortisol concentration versus time profiles and
bioavailability of once daily Chronocort(TM) and three times daily Cortef(TM) in
patients with CAH; and (2) assess the safety and tolerability of Chronocort(TM)
in the treatment of patients with CAH. The secondary objectives of the study are
to compare the pharmacodynamic response to treatment with Chronocort(TM) and
Cortef(TM) in patients with CAH. The primary endpoints include pharmacokinetic
measures and the detection of adverse events.  Secondary endpoints include
several biochemical markers of pharmacodynamic response as well as fatigue and
quality of life evaluations.



One of these biochemical markers, 17-alpha-hydroxyprogesterone ("17-OHP"), is
the proposed primary endpoint for the future Phase III pivotal study of
Chronocort(TM) in CAH. 17-OHP is an androgenic cortisol precursor that is raised
in patients with CAH.  The use of 17-OHP as the primary efficacy endpoint for
the CAH registration study has already been accepted by the EMEA, and
provisionally accepted by the FDA pending further discussion and the outcome of
the Phase II trial.  In CAH the major therapeutic challenge is to control the
levels of such androgenic cortisol precursors, hence the selection of 17-OHP as
an efficacy endpoint.  Under conventional therapy, CAH patients do not receive
hormone replacement in a manner that matches the normal circadian rhythm,
resulting in low cortisol levels overnight.  Through the resulting loss of
negative feedback these low levels of cortisol in turn lead to the adrenal
glands being driven to produce excessive quantities of androgens such as 17-OHP.
 Androgens are masculinising steroid hormones which, when produced in excessive
quantities, can cause serious health problems. Chronocort(TM), by mimicking the
circadian rhythm of cortisol levels, is expected to restore negative feedback
overnight and therefore decrease the production of androgens.



Chronocort(TM) is also under development by Phoqus for the treatment of adrenal
insufficiency ("AI"), the failure of the adrenal glands to produce sufficient
steroid hormones. Both AI and CAH require patients to take life-long
corticosteroid hormone replacement therapy. However, current therapy does not
provide steroid in a natural physiological manner and as a result often only
poorly controls disease symptoms and can lead to the unwanted side effects of
steroid therapy.  Chronocort(TM) is designed to provide a new form of
corticosteroid hormone replacement therapy by releasing hydrocortisone in a
manner that will enable doctors to achieve a daily cycle (circadian rhythm) of
cortisol levels in patients that closely matches that of the normal population.
This in turn should improve disease symptom control and may also increase the
accuracy of the disease treatment and monitoring regimen, potentially reducing
the incidence of over or under exposure to steroids.



Chronocort(TM) has successfully completed three Phase I clinical studies which
have demonstrated that it is capable of achieving the appropriate
pharmacokinetic profile. Planning is underway for the remaining clinical
development programme which includes pivotal Phase III pre-registration studies
in both CAH and in AI.



Phoqus expects the CAH Phase III study to commence during the first quarter of
2008 and complete at the end of 2008, with filing for regulatory approval in the
first quarter of 2009. The Company anticipates that Chronocort(TM) will be
available for launch in the CAH indication during the fourth quarter of 2009,
assuming an accelerated review period of six months which could potentially be
available due to the unmet medical need in these patients.



The Phase III study for patients with AI is also expected to commence during the
first quarter of 2008 and to complete during the first quarter of 2009, with
filing during the second quarter of 2009. EMEA feedback and the pre-IND meeting
with the FDA for the AI pivotal development programme are expected during August
/ September this year.



Phoqus' CEO, Dr Richard Mason, commented:



"This is Chronocort's first clinical trial in patients with congenital adrenal
hyperplasia and will enable us to assess for the first time its potential to
improve the biochemical abnormalities that underlie the serious clinical
problems that persist in these patients despite conventional therapy."





Enquiries:

Phoqus Group plc                         Tel: [phone]
Dr Richard Mason, CEO
Dr Peter Johnson, CFO

Financial Dynamics                       Tel: [phone]
David Yates/John Gilbert


Notes to Editors


About Chronocort(TM)


Chronocort(TM) is the first circadian endocrine treatment for congenital adrenal
hyperplasia ("CAH") and adrenal insufficiency ("AI").  Chronocort(TM) uses
Phoqus' proprietary Qtrol(TM)modified release technology to provide a delayed-
and-sustained release profile of hydrocortisone to mimic the natural over-night
and early morning hormone levels found in healthy individuals that are
considered important in controlling both actual disease symptoms and also
reducing unwanted side effects resulting from excess steroid treatment.



Chronocort(TM) has successfully completed a number of Phase I clinical studies
and planning is underway for the full clinical development programme which
includes pivotal pre-registration studies in both CAH patients and patients
suffering from AI.



Phoqus appointed a medical advisory board at the beginning of 2007 comprising
leading endocrinologists from Europe and the USA to assist the Company in the
design of the clinical development programmes able to demonstrate patient
benefits and clinical superiority of Chronocort(TM) over existing therapies for
both CAH and AI.



Some of the underlying intellectual property supporting the Chronocort(TM)
product is licensed from Diurnal Limited, a spin-out from the University of
Sheffield financed by Biofusion plc.  Phoqus and Diurnal collaborate on certain
aspects of Chronocort(TM)'s development.





About Phoqus



Phoqus is a speciality pharmaceutical drug development company developing
secondary care products for patients with significant unmet medical needs
through the use of its proprietary drug delivery and re-formulation
technologies. These allow the company to change the pharmacokinetic profile of
drugs, either improving their therapeutic effect (efficacy and/or safety) in
existing indications, or to change their therapeutic effect so that they may
find use in new indications.



Phoqus' core capability is in oral drug delivery and it has combined its
technology platform with expertise in formulating tablets and tablet coat
powders to create a range of innovative and diverse drug delivery applications.
The Phoqus technology is protected by a substantial patent portfolio.  Phoqus'
underlying technology platform is based upon electrostatic dry powder
deposition. This process deposits charged powder particles on to the surface of
a substrate with high precision.



Based in Kent, Phoqus was established in 1998 and was admitted to trading on AIM
in November 2005. It is listed under the symbol "PQS".



Further background on the Company can be found at www.phoqus.com.




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