Toronto Stock Exchange Symbol: AKL
MONTREAL, Nov. 12 /CNW Telbec/ - Akela Pharma Inc. (TSX: "AKL"), a drug
development company focused on developing therapies for the inhalation and
pain markets, today announced positive final results from its pilot
GHRH Phase II study. Within only 4 weeks of treatment, Akela GHRH induced a
highly significant stimulation of endogenous growth hormone (GH) secretion and
a marked increase of circulating insulin-like growth factor (IGF-1) as
compared to placebo in patients with chronic kidney disease. These endocrine
effects were associated with a significant increase in Fat Free Mass (FFM),
and concomitant reduction in Fat Mass (FM) when measured by DEXA scan and
bioelectrical impedance (BIA). As we reported in July 2007, the study did not
reveal significant changes between treatment groups in total body protein
turnover. Total body protein turnover, as measured by 13C leucine kinetics,
was normal in both treatment groups already at baseline, most probably
reflecting adaptative changes of metabolic balance in the chronic disease
ABOUT THE STUDY:
The study was conducted at 3 European sites. It was designed to evaluate
the clinical potential of GHRH analogue (AKL-0707) administration in improving
body composition, nutritional and metabolic parameters in malnourished
patients with stage IV or pre-dialytic stage V chronic kidney disease (CKD).
Malnutrition was defined by either serum albumin (less than)40 g/l, body mass
index (BMI) (less than)23, or a greater than 5% loss of body weight in the
last 6 months.
Twenty-eight patients were randomized to either GHRH analogue
subcutaneously (sc.) (13 patients) or placebo sc. (15 patients). Twenty-six
subjects completed the study as planned. The mean age was 61.8 and 63.4 in the
GHRH analogue and placebo groups, respectively. The treatment was administered
twice daily (AM & PM) for 28 days, at a dose of approximately 15 (micro)g/kg
body weight (BW).
The measurement of protein turnover as assessed by 13C-leucine kinetics
was selected as the primary parameter to monitor the trend in protein
metabolism as published clinical data suggested an improvement in lean body
mass was not to be expected within one month of treatment. In addition, the
study focused on the effect of GHRH analogue on endogenous 24-hour growth
hormone (GH) secretion, circulating total insulin-like growth factor (IGF-1)
and its binding proteins IGFBP-1 and IGFBP-3, fat-free mass (FFM) and fat mass
(FM) as assessed by Dual X-ray absorptiometry (DEXA) and bioimpedance (BIA),
biochemical parameters of nutritional and metabolic states, as well as safety
In the Intention to Treat (ITT) population, a 4-week treatment with GHRH
analogue produced the following statistically significant (p(less than)0.05)
changes in comparison to placebo:
- A 393% increase in mean 24-hour integrated GH secretion rate as
compared to a 22% increase in the placebo group (24h AUC). GHRH
analogue treatment did not affect the natural pulsatile rhythm of
endogenous GH secretion.
- A 104% increase in median total circulating IGF-1, mean 26.7% decrease
in IGFBP-1 and no significant change in IGFBP3 concentration,
indicating an increase in the free circulating IGF-1 available to
tissues, as compared to 3.5% increase in IGF-1 and 2.4% increase in
IGFBP concentrations in the placebo group.
- A marked improvement in the global nutritional state as assessed by the
physicians. In the GHRH group, 6 out of 9 patients rated malnourished
at baseline were classified well-nourished after 4 weeks of therapy. By
contrast, the nutritional assessment remained unchanged in each of
11 patients classified malnourished in the placebo group.
- An increase from baseline in FFM (median 3.3 kg by BIA and 1.6 kg by
DEXA) and a concomitant decrease in FM (median 1.8 kg by BIA and 0.4 kg
by DEXA). These changes were observed in all but one (11/12) patients
in the GHRH analogue group on day 28, and contrasted with a decrease in
FFM and an increase in FM in the placebo arm. The increase in FFM was
most pronounced in the leg and trunk regions.
- A GH-mediated increase in median extracellular water (ECW) by 1.9 L and
intracellular water (ICW) by 1.2 L. While ratio of median ECW/ICW (1.2)
on day 28 remained unchanged, indicating no negative impact in terms of
extracellular fluid retention.
- A significant increase in fasting insulin levels, as typically observed
with human growth hormone treatment. The change in fasting insulin was
not associated with adverse changes in fasting glucose or glycosylated
hemoglobin levels, indicating that the GHRH analogue treatment did not
adversely affect the glucose balance of the patients.
There were no statistically or clinically significant differences between
the treatment groups in terms of safety assessments. There were no human
anti-GHRH antibodies detected in any of the patients.
There were altogether 128 on-treatment adverse events (AE) reported by
26 subjects: 70 with GHRH analogue and 58 with placebo. Only one AE, injection
site bruising, was classified as definitely caused by GHRH analogue treatment.
Four serious adverse events (SAE) were reported, 3 in the placebo and one in
the GHRH analogue groups. None of the SAEs were considered to be related to
the study medication.
"The positive final results of our GHRH Phase II clinical trial confirm
the substantial therapeutic potential of GHRH analogue, and clearly justify
pursuing further clinical studies in not only chronic renal failure but also
in other wasting diseases such as severe COPD and HIV-infection associated
wasting." said Dr. Halvor Jaeger, Chief Executive Officer of Akela Pharma Inc.
THE ISSUER HAS FILED A REGISTRATION STATEMENT (INCLUDING A PROSPECTUS)
WITH THE SEC (FILE NO. 333-146684) FOR AN OFFERING OF ITS SECURITIES. BEFORE
YOU INVEST, YOU SHOULD READ THE PROSPECTUS IN THAT REGISTRATION STATEMENT AND
OTHER DOCUMENTS THE ISSUER HAS FILED WITH THE SEC FOR MORE COMPLETE
INFORMATION ABOUT THE ISSUER AND THIS OFFERING. YOU MAY GET THESE DOCUMENTS
FOR FREE BY VISITING EDGAR ON THE SEC WEB SITE AT WWW.SEC.GOV. ALTERNATIVELY,
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AND CO. INC. AT 125 BROAD STREET, 16TH FLOOR, NEW YORK, NEW YORK 10004,
ATTENTION: SYNDICATE DEPARTMENT, OR BY PHONE AT (212) 825 4341
Conference call information:
Akela will host a conference call at 11.00 am, on Monday November 12,
2007. Interested parties may also access the conference call by webcast at
The telephone numbers to access the conference call are 416-644-3426 or
1-800-594-3615. A replay of the call will be available until Monday
November 19, 2007. The telephone numbers to access the replay are 416-640-1917
and 1-877-289-8525 with code number 21253359#.
About Malnutrition in chronic renal failure (CRF)
CRF is a gradual and progressive loss of the ability of the kidneys to
excrete wastes, concentrate urine and conserve electrolytes. CRF usually
develops over years as the kidney structures are slowly damaged. Advanced CRF
is characterized by anorexia, malnutrition, wasting, latent inflammation,
accelerated atherosclerosis and a state of resistance to multiple endogenous
hormones. Resistance to endogenous growth hormone is believed to contribute to
tissue catabolism, but can be overcome by administration of exogenous growth
hormone at pharmacological doses. Administration of AKL-0707 may stimulate
endogenous growth hormone release sufficiently to reverse loss of muscle mass
particularly in pre-end stage CRF patients, in whom resistance mechanisms are
not as marked yet while many patients are already malnourished.
About Akela's GHRH (AKL-0707)
Akela's proprietary 29 amino-acid peptide analogue of GHRH is designed to
stimulate growth hormone secretion in patients. Positive results from its
previous Phase I/II trial showed that after administration of AKL-0707, a
rapid and very significant increase in the levels of growth hormones occurred
at all dosage levels without significant adverse events.
About Akela Pharma Inc.
Akela Pharma is an integrated drug development company focused on
developing therapies for the growing multi-billion dollar inhalation and pain
markets. Its lead product, for the treatment of breakthrough cancer pain, is a
fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry
powder inhaler platform. Its pipeline also includes therapeutics for asthma,
COPD, growth hormone deficiencies and controlled substance abuse deterrent
Akela's common shares trade on The Toronto Stock Exchange ("TSX") under
the symbol "AKL" with 11.7 million shares outstanding.
THIS NEWS RELEASE CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS THAT
REFLECT THE CURRENT VIEWS AND/OR EXPECTATIONS OF AKELA PHARMA INC. WITH
RESPECT TO ITS PERFORMANCE, BUSINESS AND FUTURE EVENTS. SUCH STATEMENTS ARE
SUBJECT TO A NUMBER OF RISKS, UNCERTAINTIES AND ASSUMPTIONS. ACTUAL RESULTS
AND EVENTS MAY VARY SIGNIFICANTLY.
For further information:
For further information: visit Akela's website at www.akelapharma.com,
or contact: Frédéric Dumais, Vice-President, Investor Relations, (514)
315-3330 ext. 106, Fax: (514) 315-3325