Basilea's U.S. phase III HANDEL study with investigational compound oral alitretinoin meets study endpoints
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Basilea Pharmaceutica AG /
Basilea's U.S. phase III HANDEL study with investigational compound oral
alitretinoin meets study endpoints
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* 40% of alitretinoin-treated severe refractory chronic hand eczema patients
achieved "clear" or "almost clear" hands compared to 15% of patients
receiving placebo
* Topline safety data consistent with established profile of oral alitretinoin
Basel, Switzerland, March 12, 2012 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announced today topline results from its U.S. phase III HANDEL study with its
investigational compound oral alitretinoin in severe chronic hand eczema (CHE)
refractory to potent topical corticosteroids. The results cover observations
made during the treatment period and the first six-month post-treatment
observation period.
In this randomized, double-blind, placebo-controlled multicenter study, 596
adult patients with severe chronic hand eczema unresponsive to potent topical
corticosteroids were randomized either to a once-daily dose of 30 mg
alitretinoin or placebo for a treatment duration of up to six months. Since
alitretinoin belongs to a pharmaceutical class that is known to be teratogenic
and contraindicated in pregnancy, strict pregnancy risk management measures were
required for women of childbearing potential who participated in the study.
Patients included in the study had a long history of disease, for an average of
seven years, and had a pre-treatment run-in period of up to four months to
confirm the refractory nature of the disease towards potent topical
corticosteroids. Patients are being followed for twelve months post treatment in
total to assess sustainability of response and safety.
At the end of treatment, 40% of patients treated with alitretinoin achieved
"clear" or "almost clear" hands compared to 15% treated with placebo (p<0.001)
based on the primary outcome measure Physician Global Assessment (PGA) in the
intent-to-treat population, thereby achieving the primary study objective.
Consistent with the physicians' assessment, the secondary outcome measure of the
Patient's Global Assessment (PaGA) demonstrated that 39% of patients treated
with alitretinoin scored themselves as "cleared" or "almost cleared", compared
to 14% of patients treated with placebo (p<0.001). In another secondary measure
of treatment effect, the modified Total Lesion Symptom Score (mTLSS), the mean
reduction in score values was 54% in patients treated with alitretinoin compared
to 30% for patients treated with placebo (p<0.001).
Analysis of the topline data indicates that alitretinoin exhibited a safety
profile consistent with that reported in previously conducted clinical studies.
During therapy the most common adverse events considered as related to
alitretinoin were headache, followed by flushing, nausea and increased blood
triglycerides.
End-of-treatment data and currently available 12-month follow-up data did not
show an impact of alitretinoin on bone mineral density. Final bone mineral
density analyses will be performed after completion of the one-year post-
treatment observation period. These data are expected to be available around
mid-year.
Dr. Anthony Man, Chief Executive Officer of Basilea Pharmaceutica International
Ltd., said, "This is an important development milestone for alitretinoin. The
topline results of this large prospective randomized trial in patients in the
U.S. are consistent with previous randomized international studies. We plan to
discuss the final study results and the requirements for a risk evaluation and
mitigation strategy (REMS) with the FDA in the second half of 2012 in the
context of a potential filing of a New Drug Application in the U.S."
For additional information on the HANDEL study please refer
tohttp://www.clinicaltrials.gov/ct2/show/NCT00817063
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Monday, March 12, 2012, 4 p.m. (CET), during which the company will discuss
today's press release.
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+1 (1) 866 291 4166 (USA)
+44 (0) 203 059 5862 (UK)
A playback will be available 1 hour after the conference call until Wednesday,
March 14, 2012, 6 p.m. (CET). Participants requesting a digital playback may
dial:
+41 (0) 91 612 4330 (Europe and ROW)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 13412 followed by the # sign.
About chronic hand eczema
Hand eczema is a common disease that tends to run a persistent, relapsing
course.[1] Hand eczema are estimated to affect up to ten percent of the general
population.[2] Approximately five to seven percent of patients with hand eczema
are estimated to suffer from severe, chronic hand eczema.[2] Chronic hand eczema
can be defined as hand eczema that last for at least three months despite
adequate dermatological treatment or when the patient has suffered at least two
relapses within a year. It is usually characterized by a combination of signs
and symptoms of thick scaly skin that gives rise to painful fissures, blisters
and abrasions, erythema, itching and edema.
About Toctino® (oral alitretinoin)
In the U.S., oral alitretinoin is an investigational drug and not approved by
the U.S. Food and Drug Administration (FDA).
Toctino® was developed by Basilea Pharmaceutica International Ltd. It is
marketed in nine European countries as well as Canada and approved in another
17 European countries and Israel as a once-daily capsule for the treatment of
adults with severe CHE that is refractory to treatment with potent topical
corticosteroids.
Alitretinoin belongs to a class of medicines (retinoids) known to cause severe
birth defects if used in pregnant women. This means that if alitretinoin is
taken during pregnancy there is a very high risk that the baby will be born with
very severe and serious malformations. For this reason strict pregnancy
prevention for one month before, during, and one month after treatment as well
as monthly pregnancy testing is required for women of childbearing potential who
take alitretinoin.
Other side effects that have been reported with variable frequency in
association with use of the retinoid class of drugs (including alitretinoin) are
psychiatric effects, depression, mood changes, suicidal ideation; inflammatory
bowel disease; alterations in serum lipids, thyroid function, liver and muscle
enzymes; mucocutaneous effects; impaired vision and hearing as well as benign
intracranial hypertension.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Through the fully integrated research and
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd. the company focuses on innovative pharmaceutical products in
the therapeutic areas of bacterial infections, fungal infections, oncology and
skin diseases, targeting the medical challenge of resistance and non-response to
current treatment options in the hospital and specialty care setting.
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition, performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different from
any future, anticipated results, performance or achievements expressed or
implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is
providing this communication as of this date and does not undertake to update
any forward-looking statements contained herein as a result of new information,
future events or otherwise.
For further information, please contact:
+-----------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-----------------------------+--------------------------------+
| Peer Nils Schröder, Ph.D. | Barbara Zink, Ph.D., MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded fromwww.basilea.com.
References
1. Meding B, Wrangsjo K, Jarvholm B. Fifteen-year follow-up of hand eczema:
predictive factors. J Invest Dermatol 2005: 124: 893-897
2. Diepgen TL, Agner T, Aberer W, et al. Management of chronic hand eczema.
Contact Dermatitis 2007: 57: 203-10
Press release (PDF):
http://hugin.info/134390/R/1593061/501149.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1593061]
Unternehmensinformation / Kurzprofil:
Datum: 12.03.2012 - 07:15 Uhr
Sprache: Deutsch
News-ID 123532
Anzahl Zeichen: 10615
contact information:
Town:
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Kategorie:
Business News
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