Novartis SEG101 (crizanlizumab, formerly SelG1) significantly reduces frequency of sickle cell pain crises in Phase II study
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Novartis International AG /
Novartis SEG101 (crizanlizumab, formerly SelG1) significantly reduces frequency
of sickle cell pain crises in Phase II study
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* SEG101 reduced annual rate of sickle cell-related pain crises (SCPC) by
45.3% compared to placebo in patients with or without hydroxyurea therapy
* SEG101 is a potential new disease-modifying, preventive treatment option for
patients with SCPC; first in nearly 20 years
* Data being highlighted in ASH 2016 media briefing, presented at Plenary
Scientific Session and published simultaneously in The New England Journal
of Medicine
Basel, December 3, 2016 - Results from the Phase II SUSTAIN study show that
SEG101 (crizanlizumab, formerly SelG1), an anti-P-selectin antibody, reduced the
median annual rate of sickle cell-related pain crises (SCPC) by 45.3% compared
to placebo (1.63 vs 2.98, p=0.010) in patients with or without hydroxyurea
therapy[1]. Novartis today announced that the data are being featured in the
official press briefing at the 58(th) American Society of Hematology (ASH)
Annual Meeting and presented during the Plenary Scientific Session tomorrow
(Abstract #1, 2:00 - 4:00 p.m. PST). The results also are being published
simultaneously in The New England Journal of Medicine.
"Acute painful episodes, commonly referred to as vaso-occlusive crises, are a
substantial cause of morbidity in sickle cell disease with limited treatment
options," said Kenneth I. Ataga, M.D., Division of Hematology/Oncology,
University of North Carolina, Chapel Hill. "These findings show that
crizanlizumab significantly reduces the frequency of painful crises and
represents a potentially novel disease-modifying therapeutic option."
In the SUSTAIN study, patients were assigned to high-dose (5.0 mg/kg), low-dose
(2.5 mg/kg) and placebo arms. The study met its primary endpoint, reduction of
the annual rate of SCPC in the high-dose arm by 45.3% vs. placebo (medians of
1.63 vs. 2.98, p=0.010). In the low- dose arm, the annual rate of SCPC was
reduced by 32.6% vs. placebo (medians of 2.01 vs. 3.0, p = 0.180). For patients
in the high dose arm, time to first SCPC vs. placebo was 2.9 times longer
(medians of 4.07 vs. 1.38 months, p = 0.001) and time to second SCPC was 2.0
times longer than placebo (medians of 10.32 vs. 5.09 months, p = 0.022)[1].
"Patients have long been in need of a new therapy for treatment of SCPC, the
most common and debilitating complication of sickle cell disease," said Bruno
Strigini, CEO of Novartis Oncology. "We are pleased that data from the SUSTAIN
study show SEG101 may have the potential to become the first new option for
patients dealing with SCPC since hydroxyurea was approved for use in sickle cell
anemia about 20 years ago[2]."
Despite its availability, hydroxyurea often is not utilized primarily due to
concerns about patient compliance and potential adverse events[3],[4].
About the SUSTAIN trial
The SUSTAIN trial was a multicenter, multinational, randomized, placebo-
controlled, double-blind, 12-month study to assess safety and efficacy of the
anti-P-selectin antibody SEG101 with or without hydroxyurea therapy in sickle
cell disease patients with sickle cell-related pain crises. Patients included in
the study had a history of 2 to 10 pain crises in the previous 12 months.
Patients receiving hydroxyurea or erythropoietin were included if prescribed for
the preceding 6 months and dose was stable for at least 3 months. The trial
randomized 198 patients age 16 to 65 to receive high dose SEG101, low dose
SEG101 or placebo[1].
Adverse events that occurred in 5% or more of patients in an active dose group
and were elevated over placebo by at least 2-fold were arthralgia, pruritus,
vomiting, chest pain, diarrhea, road traffic accident, fatigue, myalgia,
musculoskeletal chest pain, abdominal pain, influenza and oropharyngeal pain.
There were no apparent increases in infections with SeG101 treatment. Five
deaths occurred during the study, 2 at 5.0 mg/kg, 1 at 2.5 mg/kg and 2 in
placebo; no deaths were deemed related to the study drug[1].
About SEG101 (crizanlizumab)
SEG101 (crizanlizumab, formerly SelG1) is a humanized anti-P-selectin monoclonal
antibody that binds a molecule called P-selectin on the surface of endothelial
cells and platelets in the blood vessels, causing a blockade of P-
selectin[1],[5]. P-selectin drives the vaso-occlusive process[1],[6]. Vaso-
occlusive crises, also known as SCPC, occur episodically when sickle-shaped red
blood cells block blood flow through blood vessels[7]. The therapeutic blockade
of P-selectin can prevent painful vaso-occlusion in small blood vessels and
maintain blood flow[1],[7].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "potential," "potentially," "may," or similar terms, or by
express or implied discussions regarding potential marketing approvals for
SEG101, or regarding potential future revenues from SEG101. You should not place
undue reliance on these statements. Such forward-looking statements are based on
the current beliefs and expectations of management regarding future events, and
are subject to significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee that SEG101
will be submitted or approved for sale in any market, or at any particular time.
Nor can there be any guarantee that SEG101 will be commercially successful in
the future. In particular, management's expectations regarding SEG101 could be
affected by, among other things, the uncertainties inherent in research and
development, including unexpected clinical trial results and additional analysis
of existing clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
competition in general; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected manufacturing, safety or quality
issues, and other risks and factors referred to in Novartis AG's current Form
20-F on file with the US Securities and Exchange Commission. Novartis is
providing the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Ataga KI, et al. SUSTAIN: A Multicenter, Randomized, Placebo-Controlled,
Double-Blind, 12-Month Study to Assess Safety and Efficacy of SelG1 with or
without Hydroxyurea Therapy in Sickle Cell Disease Patients with Sickle Cell-
Related Pain Crises. Abstract #1. 2016 58(th) American Society of Hematology
(ASH) Annual Meeting, San Diego, California.
[2] Segal JB, Strouse JJ, et al. Evidence Reports/Technology Assessments, No.
165. Rockville, MD: Agency for Healthcare Research and Quality (US); 2008 Feb.
[3] Zumberg MS, Reddy S, et al. Hydroxyurea therapy for sickle cell disease in
community-based practices: a survey of Florida and North Carolina
hematologists/oncologists. Am J Hematol. 2005 Jun;79(2):107-113.
[4] Miller ST, Kim HY, et al. for Sickle Cell Disease Clinical Research Network
(SCDCRN). Inpatient management of sickle cell pain: A 'snapshot' of current
practice. Am J Hematol. 2012 Mar;87(3):333-336.
[5] Novartis Pharmaceuticals Corporation. Data on file. 2016.
[6] Manwani D. Frenette PS. Vaso-occlusion in sickle cell disease:
pathophysiology and novel targeted therapies. Blood. 2013; 122(24):3892-3898.
[7] Quinn CT. Anti-adhesive therapy for sickle cell disease. The Hematologist.
2014; 11(6):15.
# # #
Novartis Media Relations
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E-mail: media.relations(at)novartis.com
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Source: Novartis International AG via GlobeNewswire
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Datum: 03.12.2016 - 19:00 Uhr
Sprache: Deutsch
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