"Successful Completion of Phase II in acute myeloid leukaemia (AML) patients paved the way for important strategic fund raising"
Oslo, Norway, 27 August 2009
During the second quarter Clavis Pharma announced the successful completion of a Phase II study of its lead development candidate, elacytarabine, in late-stage acute myeloid leukaemia (AML). The study showed that compared to historical data for similar patients, elacytarabine may increase survival threefold, increase remission rates and reduce short-term mortality.
Following these positive clinical results, the Company conducted a new equity financing, raising NOK 136.8 million (gross) in a private placement and a subsequent offering. Proceeds of the offering will be used to fund the further development of the company's pipeline of novel anticancer drug candidates. The fundraising was announced in June and completed successfully in two stages in July and August.
First and second quarter report highlights:
- The Company announced in June the successful completion of a Phase II study of it's lead development candidate, elacytarabine (CP-4055), demonstrating that elacytarabine may increase survival threefold in patients with late-stage acute myeloid leukaemia (AML). Elacytarabine also demonstrated improved remission rates and reduced short-term mortality compared to detailed historical outcome analysis of similar AML patients. Based on these encouraging results, the Company is in preparation for an elacytarabine registration study in late-stage AML.
- Encouraging data from the Phase I study of elacytarabine in combination with idarubicin in AML patients was presented at the American Association of Cancer Research (AACR) 100th Annual Meeting in April in Denver, USA. Following the positive results, the Company is currently initiating a Phase II study in patients with AML who have failed their 1st course of treatment.
- In May, the Company announced pre-clinical data that differentiate CP-4200 from current standard therapy. CP-4200, Clavis Pharma's fourth drug candidate, represents a new family of Lipid Vector Technology (LVT) drugs called epigenetic modulators, which are expected to constitute an important drug class of future cancer therapy.
- The Company's R&D programs are progressing well, resulting in R&D and other operating expenses of NOK 38.7 million for the first six months of 2009. The Company had cash and cash equivalents of NOK 44.1 million as of 30 June 2009, prior to the fundraising completed in July and August.
Major events after 30 June
- The Company announced in June a private placement and a subsequent offering that was completed successfully in July and August respectively. These share offerings raised NOK 136.8 million in gross proceeds. The offerings were substantially oversubscribed and were supported by existing shareholders, as well as new institutional investors.
- In July, the United States Food and Drug Administration (FDA) approved the Investigational New Drug application (IND) for Intravenous CP-4126, thereby giving clearance to enrol patients in the clinical Phase II programme in newly diagnosed (1st line) pancreatic cancer in the USA. The programme was initiated in Europe in April. The objective is to compare the safety and efficacy of Intravenous CP-4126 to gemcitabine, with primary focus on patients with deficient levels of a certain nucleoside transporter (hENT1) responsible for the active transport of gemcitabine into cancer cells.
Commenting on today's announcement, Geir Christian Melen, the CEO of Clavis Pharma, said: "The encouraging elacytarabine phase II data has been a key development in validating the potential of our Lipid Vector Technology to produce cancer drugs with enhanced performance. This positive news coupled with the new funding that we now have in place, means that we are in a position to generate further shareholder value by continuing the development of elacytarabine and progressing our promising pipeline of differentiated anti cancer drug candidates."
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
For international press enquiries:
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
Office : +44 207 282 2948
E-mail : clavispharma@citigatedr.co.uk
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 well 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
and improved penetration into cells.
The Company's business strategy is to develop innovative oncology drug candidates until safety and efficacy has been demonstrated in humans and to establish partnerships with pharmaceutical or biotech companies for further development and commercialisation. The company may consider retaining marketing or co-marketing rights in certain territories and may develop its own sales and marketing capacity in these regions.
The company's product portfolio includes four new cancer drugs: Elacytarabine and Intravenous CP-4126 are in Clinical Phase II, 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).
Disclaimer
The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there
be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful
prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
No expressed or implied representations or warranties are given concerning Clavis Pharma or the accuracy or completeness of the information or projections provided herein, and no claims shall be made by the recipient hereof by virtue of this information or the information or projections contained herein.
Clavis Pharma(TM) is registered trademarks of Clavis Pharma ASA.