Successful Investigational New Drug application (IND) Review for
Intravenous CP-4126>
Successful Investigational New Drug application (IND) Review for Intravenous CP-4126
(Thomson Reuters ONE) - Oslo, Norway, 3 July 2009 - Clavis Pharma ASA (OSE: CLAVIS) announcestoday that it has received clearance by the United States Food andDrug Administration (FDA) to include patients in the USA in its phaseII clinical programme for Intravenous CP-4126. Intravenous CP-4126 isin development as a new, first-line treatment for pancreatic cancerand the phase II program has already been initiated in Europe. ClavisPharma will now begin preparations at selected clinical sites for anexpansion of the phase II programme into the USA.Intravenous CP-4126 is based on Clavis Pharma's proprietary LipidVector Technology (LVT) and aimed at improving the therapeuticprofile of the current standard treatment for advanced pancreaticcancer, gemcitabine (Gemzar®). Currently it is estimated thatpancreatic tumours in up to two-thirds of patients have a deficientcellular uptake of gemcitabine due to deficient expression of anecessary transport protein, hENT1 (human equilibrative nucleosidetransporter 1) on the tumour cell membrane1. This is known to limitthe efficacy of gemcitabine treatment in these patients. In contrast,cellular uptake of Intravenous CP-4126 is independent of hENT1, whichoffers a potential clinical advantage for the product in thetreatment of pancreatic cancer. In the phase II programme, cancertissue (biopsies) from each patient will be collected and analysedwith regard to levels of hENT1. The relation between response totreatment and hENT1 levels will be studied."Our phase II programme for Intravenous CP-4126 follows thesuccessful completion of a phase I study in solid tumour cancerpatients. This earlier trial, in line with preclinical data, suggeststhat CP-4126 may be of clinical benefit for patients that do notrespond to gemcitabine as well as those that currently benefit fromgemcitabine," says Geir Christian Melen, CEO of Clavis Pharma. "Theacceptance of the IND is an important milestone for us thatacknowledge our data on file for Intravenous CP-4126 and may enableus to accelerate our phase II programme through expansion in theUSA."Contact:Geir Christian MelenChief Executive OfficerOffice : +47 24 11 09 50Mobile : +47 91 30 29 65E-mail : geir.christian.melen(at)clavispharma.comGunnar ManumChief Financial OfficerOffice : +47 24 11 09 71Mobile : +47 95 17 91 90E-mail : gunnar.manum(at)clavispharma.comFor international press enquiries:Mark Swallow / Nina Enegren / David DibleCitigate Dewe RogersonOffice : +44 207 282 2948E-mail : clavispharma(at)citigatedr.co.uk1 Ref: Giovannetti et al., Cancer Research 66, 3928-3935, April 1,2006About Intravenous CP-4126CP-4126 is a novel Lipid Vector Technology analogue of gemcitabine(Gemzar®), one of the world's leading cancer drugs, used in thetreatment of several cancers, such as pancreatic cancer, ovariancancer and non-small cell lung cancer. Gemzar is a blockbuster cancerdrug, with 2008 sales of USD 1.7 billion. Clavis Pharma is developingIntravenous CP-4126, which has a different therapeutic profile andmay potentially have effect in patients who are resistant orrefractory to gemcitabine treatment.About Pancreatic cancerPancreatic cancer is a very serious disease and an indication with ahigh unmet medical need. Approximately 37,000 new cases of pancreaticcancer were recorded in the USA in 2007. The 1-year and 5-yearoverall survival rates are estimated at 23% and 4%, respectively. Themajority of these patients have unresectable disease or will recurafter surgery. Median overall survival in these patients isapproximately 8-12 months. The standard first-line therapy forpatients with unresectable disease is gemcitabine monotherapy.Unfortunately, many of these patients fail to benefit from treatment.About Clavis PharmaClavis Pharma ASA is an oncology focused pharmaceutical company usingits proprietary Lipid Vector Technology (LVT) platform to create NewChemical Entities (NCEs), by significantly improving alreadyestablished drugs. The improvements are achieved by chemicallybinding specific unsaturated lipids to existing, and well understood,approved pharmaceuticals. Data generated suggests the resultingpatentable NCEs offer improved efficacy and reduced side effectsthrough enhanced pharmacokinetic properties, greater tissuepenetration and, in many cases, additional modes of action.Clavis Pharma's objective is to develop its drug candidates untilsignificant value has been created and proof of principle in man hasbeen shown. For further clinical development and commercialisation ofthe products, Clavis Pharma will enter into strategic partnershipswith established pharmaceutical or biotech companies. The company'sproduct portfolio includes four new cancer drugs: Elacytarabine[pINN] and Intravenous CP-4126 are in Clinical phase II, Oral CP-4126in phase I, and CP-4200 is in early preclinical development. Resultsindicate that these products have promising potential for severalcancer indications within solid tumours and leukaemia.The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange(ticker: CLAVIS).DisclaimerThe information contained herein shall not constitute an offer tosell or the solicitation of an offer to buy, nor shall there be anysale of the securities referred to herein in any jurisdiction inwhich such offer, solicitation or sale would be unlawful prior toregistration, exemption from registration or qualification under thesecurities laws of any such jurisdiction.This news release contains forward-looking statements and forecastsbased on uncertainty, since they relate to events and depend oncircumstances that will occur in the future and which, by theirnature, will have an impact on results of operations and thefinancial condition of Clavis Pharma. There are a number of factorsthat could cause actual results and developments to differ materiallyfrom those expressed or implied by these forward-looking statements.Theses factors include, among other things, risks associated withtechnological development, the risk that research & development willnot yield new products that achieve commercial success, the impact ofcompetition, the ability to close viable and profitable businessdeals, the risk of non-approval of patents not yet granted anddifficulties of obtaining relevant governmental approvals for newproducts.No expressed or implied representations or warranties are givenconcerning Clavis Pharma or the accuracy or completeness of theinformation or projections provided herein, and no claims shall bemade by the recipient hereof by virtue of this Information Memorandumor the information or projections contained herein. Anyrepresentations or warranties made to an investor in Clavis Pharmawill be subject to separate sale and purchase agreements to benegotiated between the parties.Clavis Pharma is a registered trademark of Clavis Pharma ASA.This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
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Datum: 03.07.2009 - 08:25 Uhr
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