NICE, UK recommends photodynamic diagnosis of bladder cancer

Oslo Cancer Cluster member Photocure ASA, is pleased to announce that the National Institute for Health and Care Excellence (NICE) in the UK has published its first guidelines on bladder cancer, recommending photodynamic diagnosis for improved detection of bladder cancer. NICE makes evidence-based recommendations for healthcare, with the aim of improving treatment and reducing variations in care.

The NICE guidelines recognize cystoscopy as the standard for diagnosis and follow up for patients with bladder cancer, and recommend that people with suspected bladder cancer should be offered surgical removal of the tumor using white-light guided cystoscopy supported by additional techniques to improve tumor detection, such as photodynamic diagnosis.

Kjetil Hestdal, President and CEO of Photocure, said: “We are pleased to have photodynamic diagnosis included in the NICE guideline for diagnosis and management of bladder cancer. This is another important milestone providing further evidence of the value of Hexvix/Cysview in the diagnosis and management of bladder cancer patients. NICE is internationally recognised and well respected for its evidence-based recommendations.”

Photodynamic diagnosis of bladder cancer involves the instillation of a photosensitive compound, such as Hexvix®/Cysview® (hexaminolevulinate), into the bladder. Hexvix/Cysview accumulates in tumor tissue and fluoresces pink under blue light, allowing cancerous areas on the lining of the bladder to be distinguished from healthy tissue.2 Using Hexvix/Cysview as an adjunct to standard white-light cystoscopy (WLC) enables the urologist to better detect and remove lesions compared with white-light cystoscopy alone. After applying stringent cost-effectiveness analyses, NICE concluded “Photodynamic diagnosis appears to be a cost-effective alternative to WLC as an initial diagnostic test.”

Bladder cancer is the fifth most common cancer in Europe, accounting for an estimated 124,000 newly diagnosed cases and more than 40,000 deaths in 2012. Bladder cancer has a high recurrence rate (up to 78% of patients experience recurrence within 5 years of their initial diagnosis), making the lifetime costs of managing bladder cancer one of the highest of all cancers. If bladder cancer is detected at an early stage, the risk of recurrence can be reduced, and management and long-term outcomes for patients improved.

Per-Uno Malmström, Professor of Urology at Uppsala University, Sweden, said: “NICE is a leading authority in healthcare management; this recognition by NICE of the benefits that can be achieved from photodynamic diagnosis will open the door to improved management of bladder cancer for many patients.”

Gregers Hermann, Chief Urologist at Frederiksberg Hospital, Copenhagen University, Denmark, stated: “Patients with bladder cancer deserve the best evidence-based diagnosis and management of their disease. NICE guidelines highlight the proven value of photodynamic diagnosis in terms of achieving cost-effective diagnosis as well as reducing the risk of recurrence for patients with bladder cancer.”

The full NICE bladder cancer guidelines can be found here: http://www.nice.org.uk/guidance/ng2

 

About Photocure ASA
Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercialises highly selective and effective solutions in disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions that can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com

About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue-light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white-light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence. Hexvix®/Cysview® is approved in Europe and the USA.

Targovax appoints former Algeta-CFO

Mr. Øystein Soug, has been the CFO of the late-stage oncology biotech company Algeta ASA since 2008, building up the functions of Finance, IR, Compliance, IT and HR. During Mr. Soug’s period at Algeta, the company raised USD 200m capital, launched Xofigo, established production and sales in the USA, partnered with and was acquired by Bayer AG. 

Gunnar Gårdemyr, CEO of Targovax, says “I am excited to welcome Øystein Soug to Targovax. With Øystein in place we are well positioned to move our products through the important Proof of Concept phase. Øystein’s recent experience from the successful financing and sub-sequent sale of Algeta to Bayer will be important to develop Targovax further.”

Before 2008, Mr. Soug was with the Norwegian Orkla group, holding two functions; first as project manager in Orkla’s Corporate Development M&A team and later as the CFO of SladCo, the Russian operations of Orkla. Prior to Orkla, Mr. Soug spent five years in banking. He has 17 years’ experience in international finance and corporate development. In addition, he has served as Deputy Chairman and Director of Bionor Pharma ASA since 2013.

Mr. Soug has an MSc in Economics and Finance and a Master of International Management (CEMS) both from the University of St Gallen in Switzerland.

Facts:
Targovax
Targovax was established in October in 2010 to develop immunotherapy in the form of therapeutic cancer vaccines based on pioneering research at the Norwegian Radium Hospital and Norsk Hydro. Mutation of RAS is an early mutation in the transformation of a normal cell into a cancer cell.

Lead candidate TG01 educates the body’s immune system to recognize and kill cancer cells with RAS mutations. TG01 has Orphan Drug status for pancreatic cancer in the EU and US and is currently in Phase II trials in operated pancreatic cancer. The company is located in Lysaker, close to Oslo, Norway.

 

Immuno- oncology / Cancer vaccines
The Norwegian cancer research community has been in the forefront of understanding the mechanisms for immuno-oncology and cancer vaccines. A cancer vaccine educates the body’s immune system to recognize and kill the cancer cells. The TG01 vaccine is therapeutic and is given as treatment to patients after surgery of cancer patients, to prevent relapse.

 

Pancreas cancer and other RAS-mutated cancer forms
Pancreatic cancer is a disease affecting 116 000 patients each year in EU and USA, and approximately 690 persons each year in Norway. Approx 15-20% of these are discovered at an early stage and are operable. The mortality is high, and the prognosis for these patients has been more or less unchanged the last 30 years. Approximately 80-90% of patients with pancreatic cancer have RAS mutations in the cancer cells.

RAS mutations occur in approx. 20% of all cancer cases, and are also frequent in colorectal cancer, non-small cell lung cancer and other cancers. Patients with RAS mutations within these indications have proved to be difficult to treat with current treatments, and there is a significant unmet medical need.

 


Oslo, 26. februar 2015 Pressemelding no 3 -2015:

Targovax melder med stor tilfredshet at Øystein Soug er selskapets nye CFO fra 1. juni 2015.

Øystein Soug har vært Chief Financial Officer i kreft-biotekselskapet Algeta ASA siden 2008, der han bygde opp funksjonene for finans, IR, virksomhetsstyring, IT og HR. I løpet av Sougs periode i Algeta, hentet selskapet inn USD 200 millioner i kapital, lanserte Xofigo, etablerte produksjon og salg i USA og inngikk samarbeid og ble kjøpt opp av Bayer AG.

Soug hadde før 2008 to funksjoner i den norske Orkla-gruppen, først som prosjektleder i Orklas Corporate Development M&A team, og deretter som CFO i SladCo, den russiske delen av Orkla. Før Orkla var Øystein Soug fem år i bank. Han har 17 års erfaring fra internasjonal finans og selskapsutvikling. I tillegg har han vært nestleder i styret og styremedlem i Bionor Pharma ASA siden 2013.

Øystein Soug har en MSc i Økonomi og Finans og en Master i Internasjonal Ledelse (CEMS), begge fra Universitetet i St Gallen i Sveits.

Gunnar Gårdemyr, CEO i Targovax sier “Jeg er glad for å kunne ønske Øystein Soug velkommen til Targovax. Med Øystein på plass, er vi godt posisjonert for å utvikle produktene våre gjennom den viktige Proof of Concept-fasen. Øysteins nylige erfaring fra suksessfull finansiering og etterfølgende salg av Algeta til Bayer vil være viktig for å utvikle Targovax videre.»

Kontakt:

Targovax Gunnar Gårdemyr, Chief Executive Officer, mob: E-mail: ggardemyr@targovax.com

Jonas Einarsson, Chairman of the Board, mob: (+47) 48 09 63 55 E-mail: je@radforsk.no

Fakta: Targovax

Targovax ble etablert i oktober 2010 for å utvikle immunterapi i form av terapeutiske kreftvaksiner, basert på pionérforskning ved OUS Radiumhospitalet og Norsk Hydro. Mutasjoner i RAS forstyrrer normal celledeling, og bidrar til utvikling av kreftceller og svulster. Første legemiddel under utvikling, TG01, lærer opp kroppens immunsystem til å gjenkjenne og drepe kreftceller med RAS-mutasjoner. TG01 har Orphan Drug Status for bukspyttkjertelkreft i EU og USA, og er nå i fase II klinisk utvikling innen operabel bukspyttkjertelkreft. Selskapet er lokalisert på Lysaker utenfor Oslo.

Immuno-onkologi / kreftvaksiner

Det norske kreftforskningsmiljøet har vært i forskningsfronten når det gjelder å forstå mekanismene for immuno-onkologi/immunterapi og kreftvaksiner. En kreftvaksine lærer opp kroppens immunsystem til å gjenkjenne og drepe kreftcellene. TG01 er terapeutisk, den gis som behandling til pasienter etter kirurgi, for å forhindre tilbakefall.

Bukspyttkjertelkreft og andre RAS-muterte kreftformer.

Bukspyttkjertelkreft er en sykdom som rammer 116 000 pasienter hvert år i EU og USA, og ca 690 pasienter årlig i Norge. Ca 15-20% av disse avdekkes på et tidlig stadium og kan opereres. Dødeligheten er høy, og prognosen for disse pasientene har vært mer eller mindre uendret de siste 30 år. Ca 80-90% av pasienter med bukspyttkjertelkreft har RAS-mutasjoner i kreftcellene.

RAS-mutasjoner forekommer i ca 20% av alle krefttilfeller, også ofte i tykktarmskreft, ikke-småcellet lungekreft og andre kreftformer. Pasienter med RAS – mutasjoner innen disse sykdommene har vist seg å være vanskelig å behandle med dagens tilgjengelige medisiner, og det er et stort udekket medisinsk behov.

– See more at: http://www.noodls.com/viewNoodl/27052320/targovax-as/trvx-targovax-appoints-216ystein-soug-as-new-cfo#sthash.zygqEXIj.dpuf

Lifandis, Smartfish and BerGenBio got funding from BIA

The Norwegian Research Council granted BerGenBio, Lifandis and Smartfish –  all Oslo Cancer Cluster member companies – funding through the Programme for User-Driven Research Based Innovation (BIA).

In total, the Research Council will grant a record amount of over 600 MNOK to 65 Norwegian companies, of which 9 are biotech companies.

BerGenBio, Lifandis and Smartfish will receive around 10 million NOK each over 4 years, depending on the outcome of the contract negotiations between the council and the companies. Funding from the BIA programme is a quality stamp since the companies compete in “open class” where all sectors are represented. The funding may also trigger interest  from private investors. BerGenBio also received funding from BIA one year ago.

On the Research Council`s website you may more information and a list of all the companies that received funding now (in Norwegian).

October 14th 2015 is next application deadline  for funding from the BIA-programme.

Partnership4Life – oncology session and opportunity to do 1:1 meetings

February 12, LMI, DNB Healthcare, AbbVie, Novartis and Pfizer hosts a one day seminar called A partnership for life in 2015 – How to develop a strong Norwegian biotechnology and health industry sector?

Oslo Cancer Cluster is well represented this day; we will host an oncology session and Jónas Einarsson, CEO Radium Hospital Research Foundation, will give a spech on Norwegian biotech and health industry from words to action. There will also be opportunity to do 1: 1 meetings with potential partners.

Global biotech and pharmaceutical industry, academia, financial institutions, investors, hospitals and politicians are invited to participate.

The program is twofold. Before lunch there will be an overarching focus with introductions and a panel discussion on this subject. After lunch there will be shorter seminars where different actors will exchange information and experiences.

Finally, it is allocated time for the 1: 1 meetings between potential partners. The day ends with dinner at Cafe Christiania in Oslo.

  • Register her
  • Register for 1:1 meetings by sending e-mail to monica@lmi.no to be put in contact with the international companies

PROGRAM
Forskningsparken, 12 February 2015

8:30 to 9:00 Registration and refreshments

9:00 to 9:15 Opening

9:15 to 9:30 Travelogue from Silicon Valley
Alexander Woxen, entrepreneur and investor

9:30 to 10:00 Introduction by Ministry of Economics
Dilek Ayhan, Secretary in the Ministry of Industry

10:00 to 10:15 Norwegian biotech and health industry from words to action
Jonas Einarsson, CEO Radium Hospital Research Foundation

10:15 to 11:30 Plenary Discussion: “How do we build a strong Norwegian biotech and health industry sector.”
Else-May Botten (AP)
Harald Tom Nesvik (FRP)
Trine Skei Grande (Left)
Karita Bekkemellem (LMI)
Benedicte Bakke (DNB)
Alexander Woxen (Investor)
Sander Tufte (Research)
Thomas Ramdahl (Bayer)

13.00 to 14.30 Parallel Sessions on 1 Public-private research collaborations and 2 Access to capital

14.30 to 15.00 Coffee and refreshments

15.00 to 16.30 Exchange of research ideas and focus. Introduction of national and international companies about their research focus. Parallel Sessions: Neuroscience and Oncology.

Session: Oncology

  • Elisabeth Kirkeng Andersen, Head of Communication in Oslo Cancer Cluster (chairperson)
  • Dr. Morten Sogaard, Vice President and Head Enterprise Scientific Technology Operations in Pfizer Worldwide R&D
  • Dr. Peter Schuld, Head of Medical Affairs Oncology Western European Cluster in Novartis
  • Dr. Anil Singahl, Vice President & Head, AbbVie biotherapeutics
  • Øyvind, Arnesen, CEO Ultimovacs
  • Konstantinos Alevizopoulos, CEO Apim Therapeutics

Session: Neuroscience

  • Leif Rune Skymoen, CEO Nansen Neuroscience Network
  • Dr Scott Brown, Vice President of Pharmaceutical Development in AbbVie
  • Dr. Morten Sogaard, Vice President and Head Enterprise Scientific Technology Operations in Pfizer Worldwide R & D

16.30 to 18.30 Possibility of 1-1 meetings between national and international companies
In agreement with the companies. Interested parties may send email to monica@lmi.no to be put in contact with the international companies.

19.00 to 22.30 Dinner at Cafe Christiania
Lower Vollgate 19, 0158 Oslo (Entrance from Stortingsgaten)

Ultimovacs carries out NOK 45 million share issue with Canica AS and Sundt AS as the main investors

Oslo Cancer Cluster member Ultimovacs AS has carried out a successful NOK 45 million share issue with DNB Markets and Arctic Securities as financial advisors. The issue was fully subscribed by new shareholders. The two biggest new shareholders are Canica AS and Sundt AS.

 

The funds raised through the share issue will be used to implement and further develop the company’s programme to document the effect of its first product; the therapeutic cancer vaccine UV1. During the next two years, the company will complete and finish two clinical trials to show how UV1 activates the immune system.

In addition, Ultimovacs began a third trial in January 2015 to explore efficacy and safety of UV1 is in combination with another drug that also manipulates the immune system into attacking cancer cells. The new funds will also cover the costs of this trial and allow the company to establish and document a commercial-scale production process for UV1.

CEO Øyvind Kongstun Arnesen comments: ‘This share issue enables the company to maintain its strong professional focus as it continues its work on documenting efficacy and safety of UV1 is in cancer treatment. We are very pleased to have some of the strongest investment communities in Norway on our team. The new owners recognise the company’s ambitions to improve the current cancer treatment while developing a business enterprise with great potential.’

Canica looks forward to further developing Ultimovacs in cooperation with an expert community and a sound investor base. ‘We believe that the company is well placed to succeed with its innovative immunotherapy,’ says Nils Selte, CEO of Canica.

Leiv Askvig, CEO of Sundt, comments: ‘With its universal cancer vaccine, Ultimovacs has great potential, both when it comes to developing new cancer treatments to benefit patients and creating good value for shareholders.’

Ultimovacs is a biotechnology company that develops a therapeutic universal cancer vaccine. Such cancer treatment is not linked to a specific type of cancer, but has the potential to trigger a general immunologic reaction against cancer cells, regardless of the type of cancer. Stimulating the immune system to attack cancer cells is a revolutionary form of cancer treatment and a treatment principle in rapid international development. Several new treatments based on this principle have already been introduced, and the technology has the potential to greatly improve the treatment options available for cancer. The Norwegian academic communities and companies that belong to Oslo Cancer Cluster are world-leading in this field. Ultimovacs is one such company.

About Ultimovacs:

Ultimovacs AS was established by Inven2 in 2011. The company’s goal is to develop technology from the Norwegian Radium Hospital for use in cancer treatment and to make the treatment available to patients. The technology is based on the possibility of controlling the immune system to make it recognise and kill cancer cells.

Ultimovacs is carrying out three clinical trials intended to document that the company’s main product, UV1, can produce a controlled immune response and is safe to use, either alone or in combination with other drugs that also activate the immune system to attack cancer cells.

The biggest shareholders in the company are Gjelsten Holding AS, Inven2, Langøya Invest AS, Canica AS, Sundt AS and the Norwegian Radium Hospital Research Foundation. From July 2015, the company will be located in Oslo Cancer Cluster Innovation Park at Montebello.