Axelar reports good safety profile of AXL1717 in Phase I/II in cancer patients
(Thomson Reuters ONE) -
STOCKHOLM, SWEDEN - September 26, 2011. Axelar AB, a Karolinska Development AB
portfolio company, today releases results of the completed Phase I/II clinical
safety study for its drug candidate AXL1717 at the European Multidisciplinary
Cancer Congress (ESMO) meeting in Stockholm, Sweden. All major objectives were
met in the study and signs that suggest clinical benefit were observed in some
patients with non-small cell lung cancer.
AXL1717 is the first targeted oral small-molecule Insulin-like Growth Factor 1
(IGF-1) receptor inhibitor clinically tested which does not affect the closely-
related insulin receptor. The drug was administered to a total of 49 advanced-
stage cancer patients with progressive solid tumors who had no remaining
treatment options. The main purpose of the study was to investigate the safety
profile of AXL1717. The open label study consisted of three parts: a single day
twice-daily ascending dose part, a 7-28 days twice-daily dose-finding part, and
an extension part at a fixed twice-daily dose for 28 days in two cycles 14 days
apart.
All major objectives have been met in the clinical study and the results from
the study show that:
* AXL1717 was well-tolerated with no unexpected drug-related dose-limiting
adverse events even at exposures being 5-10 fold higher than those needed
for obtaining anti-tumor activity in animals. No changes in blood levels of
glucose, insulin or C-peptide were reported.
* Dose-related, easily-monitored and reversible neutropenia was the only dose-
limiting event. Since neutropenia has been shown in toxicity studies in
animals, this event was expected to occur also in man. The recommended Phase
II dose was found to be 400 mg AXL1717 twice-daily as monotherapy in a
continuous 28-day treatment. At this dose only few neutropenias were
registered.
Fifteen non-small cell lung cancer (NSCLC) patients administered with AXL1717 as
single agent treatment with a total duration of at least two weeks were
reported. The patients were assessed with imaging at the start of the study and
thereafter every two months.
In spite of the study design with repeated wash-out periods and frequent dose
changes, signs that suggest clinical benefit were observed in these fifteen
NSCLC patients. Partial response in one of the NSCLC patients, according to
RECIST criteria, was reported following treatment with AXL1717 as monotherapy.
At cut-off, five patients were still alive and two of these patients had not
reported progression. The results may therefore improve further over time.
The next step will be to study clinical efficacy with continuous dosing of the
AXL1717 drug candidate in a randomized Phase II study in NSCLC patients, a
program which is fully financed.
Dr. Johan Harmenberg, CEO, Axelar:
"We are very satisfied with the results of the study that support Axelar's
strategy to direct the upcoming randomized Phase II program towards patients
with non-small cell lung cancer. We believe that AXL1717 has the potential to
become an effective treatment in patients with lung cancer."
Dr. Torbjörn Bjerke, CEO, Karolinska Development:
"Axelar is one of Karolinska Development's prioritized companies. The data
presented today from the completed clinical study strengthens our belief that
AXL1717 can become an important novel treatment for patients with non-small cell
lung cancer, and potentially those with other tumors. We look forward to the
next important milestone which is the initiation of the randomized Phase II
study."
A poster with more detailed data from the clinical study will be presented at
ESMO at 2.00 p.m. today and thereafter it will also be available on Axelar's and
Karolinska Development's websites.
For further information, please contact:
Johan Harmenberg, CEO, Axelar AB
Phone: +46 (0) 70 514 54 53, e-mail: johan.harmenberg(at)axelar.se
Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke(at)karolinskadevelopment.com
TO THE EDITORS
About Axelar
Axelar AB is a Swedish biotech company founded in 2003. The company is
developing insulin-like growth factor-1 (IGF-1) receptor inhibitors for
treatment of cancer and other diseases. Axelar is part of the Karolinska
Development portfolio of companies. www.axelar.se
About AXL1717
Axelar's lead compound, AXL1717 provides a novel potential treatment regimen for
a wide range of cancers. AXL1717 is the first targeted oral small-molecule
Insulin-like Growth Factor 1 (IGF-1) receptor inhibitor with no observable
effect on the closely-related insulin receptor. Most tumor cells are dependent
on the IGF-1 receptor signal pathway and the IGF-1 receptor is therefore
regarded as a promising target for cancer therapy. To date, there are no IGF-1
receptor inhibitor drugs on the market. AXL1717 has just completed its first-in-
man phase I/II clinical trial and the compound has already demonstrated a
superior preclinical efficacy against numerous tumors and an excellent
tolerability profile.
About Karolinska Development
Karolinska Development aims to create value for investors, patients, and
researchers by developing innovations from world class research into products
that can be sold or out-licensed with high returns. The business model is to:
SELECT the most commercially attractive medical innovations; DEVELOP these to
the stage where the greatest return on investment can be achieved; and
COMMERCIALIZE the innovations through the sale of companies or out licensing of
products. This will result in upfront payments, milestone payments and
royalties.
An exclusive deal flow agreement with Karolinska Institutet Innovations AB,
along with other cooperation agreements with leading Nordic universities,
delivers a continuous flow of innovations.
Karolinska Development's flexible exit strategy enables projects to be exited at
whichever stage of development offers the greatest return on investment, usually
after Phase II clinical trials have indicated the desired pharmaceutical effect
on patients - this being an important value enhancing step.
Today, the portfolio consists of over 35 projects at various stages, from
concept development to Phase II clinical trials, twelve projects are in clinical
trials. The portfolio is particularly strong in the areas of cancer,
dermatology, inflammation, cardiovascular disease, women's health and diseases
that affect the central nervous system. For more information, see
www.karolinskadevelopment.com.
Press release as PDF:
http://hugin.info/143071/R/1549505/476491.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Karolinska Development AB (publ) via Thomson Reuters ONE
[HUG#1549505]
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Datum: 26.09.2011 - 08:31 Uhr
Sprache: Deutsch
News-ID 69181
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