Toronto Stock Exchange Symbol: AKL
MONTREAL, Sept. 5 /CNW Telbec/ - AKELA Pharma Inc., (TSX: AKL), a drug
development company focused on developing therapies for the inhalation, pain
and CNS markets, today announced positive results from the double-blind
extension part of its Fentanyl TAIFUN(R) Phase IIb trial. The results
demonstrated statistically significant differences compared to placebo in the
measured primary and secondary efficacy variables resulting in faster and
superior pain relief. Fentanyl TAIFUN(R) is a fast-acting Fentanyl formulation
delivered using the Company's TAIFUN(R) dry powder inhaler platform.
A total of 50 patients were randomized and started the extension part of
the study. In the Intent-To-Treat (ITT) population, the median time to
significant pain relief in the Fentanyl TAIFUN(R) group as measured by a
decrease of at least 2 points on the numerical pain scale (NPS) was
5.2 minutes, which was statistically significantly faster when compared to
placebo (P=0.007). The mean difference in sum of pain intensity difference
(SPID) was also statistically significantly in favor of Fentanyl TAIFUN(R) for
the whole 60 min pain episode (P=0.050). This was already seen in numerical
pain scale scores up to 15 minutes (P=0.008) when compared to placebo.
"We are extremely satisfied to have demonstrated beyond doubt the faster
and superior pain relief provided by Fentanyl TAIFUN(R) to patients. The
additional knowledge and data accumulated during this clinical trial, as well
as the positive feed-back by the authorities during the recent End-of-Phase II
meetings makes us confident when preparing our Phase III study protocols."
said Dr. Halvor Jaeger, Chief Executive Officer of Akela Pharma Inc.
Phase IIb for Fentanyl TAIFUN(R) was a multi-center, multinational
clinical trial in cancer patients with severe persistent pain on maintenance
opioid therapy. The first part of the trial was a single arm, open-label dose
titration to evaluate the effective individual dose for significant pain
relief with Fentanyl TAIFUN(R) in the treatment of breakthrough cancer pain.
The second part included responders from the open-label part randomized to
receive the titrated doses or placebo.
Chronic pain associated with advanced cancer is commonly treated with
strong opioid analgesics, such as fentanyl. Breakthrough pain episodes are
sudden and intense flares of pain that "break through" a long-acting
continuous treatment, such as a transdermal patch or a slow release tablet.
Breakthrough pain episodes are common in cancer patients, often occurring
several times a day.
Conference call information:
Akela will host a conference call at 11:00 am, on Wednesday September 5,
2007. Interested parties may also access the conference call by webcast at
The telephone number to access the conference call is 1-800-731-5319. A
replay of the call will be available until Wednesday September 12, 2007. The
telephone numbers to access the replay are 416-640-1917 and 1-877-289-8525
with code number 21245927#.
About Akela Pharma Inc.
Akela Pharma is an integrated drug development company focused on
developing therapies for the growing multi-billion dollar inhalation, pain and
CNS 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
Akela's common shares trade on The Toronto Stock Exchange ("TSX") under
the symbol "AKL" with 82.3 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; Tina Posterli (U.S. Media), (917)