Novartis provides update on pegpleranib Phase III clinical trial program in patients with neovascular age-related macular degeneration (nAMD or wet AMD)
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Novartis International AG /
Novartis provides update on pegpleranib Phase III clinical trial program in
patients with neovascular age-related macular degeneration (nAMD or wet AMD)
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* Two pivotal Phase III studies did not show additional improvement in best
corrected visual acuity (BCVA) for pegpleranib and Lucentis (ranibizumab)
combination treatment over standard of care Lucentis monotherapy[1],[2]
* Recent Lucentis EU approval in new choroidal neovascularization (CNV)
indication demonstrates Novartis' strong commitment to innovate and grow
Lucentis (ranibizumab) as standard of care in diseases of the retina -
Lucentis is the only treatment available for a wide range of CNV conditions
* Novartis continues to discover and develop next generation of treatment for
neovascular age-related macular degeneration (nAMD) patients with RTH258
Basel, December 12, 2016 - Novartis today announced initial topline results from
two pivotal Phase III clinical studies evaluating the safety and efficacy
of pegpleranib in combination with Lucentis(® )(ranibizumab) for the treatment
of neovascular age-related macular degeneration (nAMD). Studies OPH1002 and
OPH1003, sponsored by Ophthotech Corporation, did not meet the primary endpoint
of superiority for the pegpleranib and ranibizumab combination therapy, measured
as best corrected visual acuity (BCVA) in terms of additional letter gains over
ranibizumab monotherapy. At month 12, patients in the pegpleranib and
ranibizumab combination treatment groups showed a 10.74 letter BCVA improvement
in study OPH1002[1] and a 9.91 letter BCVA improvement in study OPH1003[2].
Patients treated with ranibizumab alone showed a 9.82 letter BCVA improvement in
the OPH1002[1] study and a 10.36 letter BCVA improvement in the OPH1003[2]
study.
"We are fully committed to innovate and grow Lucentis as standard of care in
diseases of the retina and to continue our research in this area. The key
message from the data is that the proven efficacy of Lucentis monotherapy was
not improved by the addition of pegpleranib", said Vasant Narasimhan, Global
Head, Drug Development and Chief Medical Officer, Novartis. "Together with
Ophthotech we continue to analyze the data. We are confident that underlying
data will provide further understanding and guidance on how best to help
patients with this disease. Novartis continues researching new treatment options
for patients with nAMD, and we are looking forward to the phase III results of
our next generation treatment RTH258."
Data from the OPH1002 and OPH1003 studies, including secondary and exploratory
efficacy endpoints, will be presented at a future medical meeting.
About the OPH1002 and OPH1003 studies
The OPH1002 and OPH1003 studies are both randomized, double blind, Phase III
clinical trial studies designed to evaluate the safety and efficacy of
pegpleranib 1.5mg in combination with ranibizumab versus ranibizumab monotherapy
in people with subfoveal neovascular age-related macular degeneration
(nAMD)[1],[2]. A total of 1,248 patients over the age of 50 were enrolled across
both studies (621 patients in the OPH1002 study and 627 patients in the OPH1003
study)[6] and were randomized to receive either pegpleranib in combination with
ranibizumab or ranibizumab alone each month up to the 12 month primary endpoint
of the study[1],[2].
The primary efficacy endpoint in both studies was defined as mean change in best
corrected visual acuity (BCVA) from baseline at 12 months. A number of secondary
and exploratory efficacy endpoints are currently being analyzed across both
studies[1],[2].
About nAMD
Age-related macular degeneration (AMD) is a common and degenerative eye
condition caused by damage to the macula[3], and is globally ranked as the third
most common cause of blindness[7]. The disease is a leading cause of vision loss
in people aged over 50 years[3] and impacts an estimated 20 to 25 million people
worldwide[4]. It is the primary cause of blindness in industrialized
countries[7]. Neovascular age-related macular degeneration (nAMD or wet AMD)
occurs when abnormal blood vessels form underneath the macula and cause damage
to the cells, particularly if they leak blood and fluid into the eye[8]. Without
treatment, vision deteriorates within days[8].
About pegpleranib
Pegpleranib is a 32-mer pegylated DNA aptamer that selectively binds to PDGF-BB
and PDGF-AB homo and hetero-dimers, respectively, thereby disrupting the
interaction with their cognate tyrosine kinase receptors (PDGF-BB with PDGFR-
alpha alpha, PDGFR -ßß and PDGFR-alpha ß; PDGF-AB with PDGFR-alpha alpha and
PDGFR-alpha ß). These receptors are commonly expressed on cells of mesenchymal
origin such as pericytes[9]-[13].. In a preclinical model, pegpleranib potently
stripped neovascular pericytes from the underlying endothelial cells[14].
Pericyte stripping from a neovascular complex may leave the underlying
endothelial cells in an unprotected and vulnerable state, thereby increasing
their sensitivity to the effects of VEGF blockade[9]-[10],[12],[15]-[17].
Pegpleranib is currently being investigated in Phase III clinical trials for the
treatment of neovascular age-related macular degeneration (nAMD or wet
AMD)[1],[2],[5]
About the Ophthotech and Novartis license and commercialization agreement
In May 2014, Novartis signed a license and commercialization agreement with
Ophthotech Corporation (Ophthotech) and holds the exclusive rights to
pegpleranib outside the United States. Ophthotech holds the rights to
pegpleranib in the United States.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "commitment," "continues," "next generation," "continue,"
"confident," "will," "committed," "looking forward," "being analyzed," "being
investigated," or similar terms, or by express or implied discussions regarding
potential marketing approvals for RTH258, potential marketing approvals for
pegpleranib, alone or in combination with Lucentis, potential new indications or
labeling for Lucentis, alone or in combination with pegpleranib, or regarding
potential future revenues from RTH258, pegpleranib, Lucentis, or the combination
of pegpleranib and Lucentis. 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 RTH258 will be
submitted or approved for sale in any market, or at any particular time. Neither
can there be any guarantee that pegpleranib, alone or in combination with
Lucentis, will be submitted or approved for sale in any market, or at any
particular time. Nor can there be any guarantee that Lucentis, alone or in
combination with pegpleranib, will be submitted or approved for any additional
indications or labeling in any market, or at any particular time. Neither can
there be any guarantee that RTH258, pegpleranib, Lucentis, or the combination of
pegpleranib and Lucentis will be commercially successful in the future. In
particular, management's expectations regarding RTH258, pegpleranib, Lucentis,
and the combination of pegpleranib and Lucentis 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; global trends
toward health care cost containment, including ongoing pricing pressures;
unexpected safety, quality or manufacturing 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] ClinicalTrials.gov. Identifier NCT01944839. Available at
https://clinicaltrials.gov/ct2/show/NCT01944839. Accessed October 2016.
[2] ClinicalTrials.gov. Identifier NCT01940900. Available at
https://clinicaltrials.gov/ct2/show/NCT01940900. Accessed October 2016.
[3] National Eye Institute. Facts About Age-Related Macular Degeneration.
Available at https://nei.nih.gov/health/maculardegen/armd_facts. Accessed
October 2016.
[4] Chopdar et al. Age related macular degeneration. BMJ
2003; 326(7387): 485-488.
[5] ClinicalTrials.gov. Identifier: NCT01940887. Available at
https://clinicaltrials.gov/ct2/show/NCT01940887. Accessed October 2016.
[6] Novartis data on file.
[7] World Health Organization. Priority eye diseases: Age-related macular
degeneration. Available at
http://www.who.int/blindness/causes/priority/en/index7.html. Accessed October
2016.
[8] NHS Choices. Macular Degeneration. Available at
http://www.nhs.uk/Conditions/Macular-degeneration/Pages/Introduction.aspx.
Accessed October 2016.
[9] Benjamin LE, Hemo I, Keshet E. A plasticity window for blood vessel
remodelling is defined by pericyte coverage of the preformed endothelial network
and is regulated by PDGF-B and VEGF. Development. 1998; 125:1591-1598.
[10] Jo N, Mailhos C, Ju M, et al. Inhibition of platelet-derived growth factor
B signaling enhances the efficacy of antivascular endothelial growth factor
therapy in multiple models of ocular neovascularization. Am J Pathol.
2006; 168: 2036-2053.
[11] Andrae J, Gallini R, Betsholtz C. Role of platelet-derived growth factors
in physiology and medicine. Genes Dev. 2008; 22:1276-1312.
[12] Hall AP. Review of the pericyte during angiogenesis and its role in cancer
and diabetic retinopathy. Toxicol Pathol. 2006; 34:763-775.
[13] Fredriksson L, Li H, Eriksson U. The PDGF family: four gene products form
five dimeric isoforms. Cytokine Growth Factor Rev. 2004; 15:197-204.
[14] Mitchell TS, Bradley J, Robinson GS, et al. RGS5 expression is a
quantitative measure of pericyte coverage of blood vessels. Angiogenesis.
2008; 11:141-151.
[15] Bergers G, Hanahan D. Modes of resistance to anti-angiogenic therapy. Nat
Rev Cancer. 2008; 8:592-603.
[16] Erber R, Thurnher A, Katsen AD, et al. Combined inhibition of VEGF and PDGF
signaling enforces tumor vessel regression by interfering with pericyte-mediated
endothelial cell survival mechanisms. FASEB J. 2004; 18:338-340.
[17] Carmeliet P, Jain RK. Molecular mechanisms and clinical applications of
angiogenesis. Nature. 2011; 473:298-307.
# # #
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 12.12.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 512094
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Business News
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