Elacytarabine Phase II in acute myeloid leukaemia (AML)
Positive data from the elacytarabine (CP-4055) Phase II study in patients with late stage acute myeloid leukaemia (AML) will be presented at the poster session on Saturday, May 30, 2009 at 8:00AM - 12:00PM EDT (Location: Level 2, West Hall C). The poster, abstract # 7047, is titled "A phase II study with CP-4055 in patients with second salvage AML". An interim analysis of efficacy and safety data from 40 patients will be presented. The data have been assessed by an independent data monitoring committee and confirms the positive results (20 patients) presented at the American Society of Hematology Annual Meeting 2008.
Intravenous CP-4126 Phase I in solid tumours
Promising data from the first Phase I study of the novel nucleoside analogue Intravenous CP-4126 in patients with advanced
solid tumours will be presented at the poster session on Saturday, May 30, 2009 at 8:00AM - 12:00PM (Location: Level 2, West
Hall C). The poster, abstract # 2577, is titled " First-in-human study of a novel nucleoside analogue, CP-4126, in patients
with advanced solid tumors". The objectives of the study was to determine the maximum tolerated dose, the recommended dose
for Phase II studies, and to establish the safety profile and pharmacokinetic characteristics of Intravenous CP-4126. The
complete results of the Phase I study will be presented, confirming previously presented encouraging data.
"We are pleased that ASCO has accepted studies from our two lead development products for presentation this year" says CEO Geir Christian Melen in Clavis Pharma. "The results demonstrate that we have a promising oncology portfolio covering both solid tumours and haematological malignancies."
Contact:
Geir Christian Melen
Chief Executive Officer
Office : +47 24 11 09 50
Mobile : +47 91 30 29 65
E-mail :
geir.christian.melen@clavispharma.com
Gunnar Manum
Chief Financial Officer
Office : +47 24 11 09 71
Mobile : +47 95 17 91 90
E-mail :
gunnar.manum@clavispharma.com
About Elacytarabine and nucleoside transporter (hENT1)
Clavis Pharma's lead product candidate elacytarabine (CP-4055) is a patented Lipid Vector Technology (LVT) version of the
gold standard leukaemia drug, cytarabine. Elacytarabine has in clinical Phase I studies shown activity in haematological malignancies
and a variety of solid tumours, and has shown superior activity over the parent drug cytarabine in a variety of preclinical
tumour models. Many Acute Myeloid Leukaemia (AML) patients respond poorly to cytarabine treatment. Published data indicate
that this is due to low expression levels of a specific cellular uptake mechanism (a specific nucleoside transporter, hENT1)
required for cellular uptake of cytarabine (Hubeek et al, Br J Cancer 2005 and Galmarini et al, Leukemia Research, 2002). One important characteristic of elacytarabine is its independence of this cellular uptake mechanism for cellular uptake,
indicating that elacytarabine may provide superior clinical benefit for these patients.
Both the US Food & Drug Administration (FDA) and the European Commission have granted orphan drug designation to elacytarabine for the treatment of Acute Myeloid Leukaemia (AML). These designations represent important milestones in the Company's strategy to achieve marketing approval for elacytarabine as rapidly and efficiently as possible. Elacytarabine is proposed by the World Health Organization as the international non-proprietary name (pINN) for CP-4055. The proposal is supported by the United States Adopted Name Council. Elacytarabine is also in Phase II in ovarian cancer.
About Intravenous CP-4126
Intravenous CP-4126 is a patented LVT analogue of gemcitabine (Gemzar®, Eli Lilly), a blockbuster cancer drug and one of the
leading products on the world oncology market.
The standard treatment for advanced pancreatic cancer is currently gemcitabine. Unfortunately, published data indicate that many patients respond poorly to gemcitabine treatment. Up to 2/3 of pancreatic cancers have a deficient cellular uptake of gemcitabine due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the cell membrane (Giovannetti et al., Cancer Research 2006;66:3928-3935) .Cellular uptake of Intravenous CP-4126 in contrast to gemcitabine is independent of hENT1, which offers a potential clinical advantage to Intravenous CP-4126 in the treatment of pancreatic cancer and lung cancer.
About Clavis Pharma
Clavis Pharma ASA is an oncology focused pharmaceutical company using its proprietary Lipid Vector Technology (LVT) platform
to create New Chemical Entities (NCEs), by significantly improving already established drugs. The improvements are achieved
by chemically binding specific unsaturated lipids to existing, and well understood, approved pharmaceuticals. Data generated
suggests the resulting patentable NCEs offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties,
greater tissue penetration and, in many cases, additional modes of action.
Clavis Pharma's objective is to develop its drug candidates until significant value has been created and proof of principle in man has been shown. For further clinical development and commercialisation of the products, Clavis Pharma will enter into strategic partnerships with established pharmaceutical or biotech companies. The company's product portfolio includes four new cancer drugs: Elacytarabine is in Clinical Phase II, Intravenous CP-4126 is in Clinical Phase I, Oral CP-4126 in Phase I, and CP-4200 is in early preclinical development. Results indicate that these products have promising potential for several cancer indications within solid tumours and leukaemia.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS).
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