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Positive results on bile duct cancer from PCI Biotech

The PCI Biotech stock went straight up on the Norwegian Stock Exchange after successful results from the first dose cohort in the phase I/II study of Amphinex in combination with the cytotoxic agent gemcitabine in patients with inoperable bile duct cancer (cholangiocarcinoma). No safety concerns were observed at this dose level.

PCI Biotech have previously shown promising results from phase I/II on head- and neck cancer using the same technology as in this phase I study on bile duct cancer, where the three first patients now has been treated.

Targeted therapy
The PCI-technology was developed at the Norwegian Radium Hospital in the nineties, and is a targeted therapy using light to enhance the effect of existing drugs. PCI is an abbreviation for photochemical internalisation and refers to the process of using light to destabilize the cell membrane of the cancer cells in order to deliver the cancer drug effectively.

Bile duct cancer is rare, but extremely severe. PCI Biotech have chosen bile duct cancer due to a clear medical need for a better local treatment, access with light is easy by using already established treatment procedures and one of the most used cytotoxic agents, gemcitabine, is one of the drugs that is significantly enhanced by PCI in preclinical studies.

Please read the press release here.

The PCI technology
Photochemical internalisation (PCI) technology is a technology for light-directed drug delivery, used to enhance the effect of drugs by targeted illumination of the diseased areas of the body.

About PCI Biotech
PCI Biotech has been listed on Oslo Stock Exchange since 2008. The company is offering effective local treatment solutions in cancer through its proprietary photochemical internalisation (PCI) technology. PCI Biotech’s lead photosensitiser Amphinex® is in Phase II clinical development in head and neck cancer in combination with the cytotoxic bleomycin and in Phase I/II clinical development in bile duct cancer in combination with gemcitabine. Read more on PCI Biotech’s website

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5 Oslo Cancer Cluster SMEs granted BIA-funding

The Norwegian Research Council recently granted BerGenBio, PCI Biotech, Lytix Biopharma, Oncoinvent and Ultimovacs –  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 444 million to 58 Norwegian companies over four years, of which 10 are biotech companies – which is also a new record.

BerGenBio, Lytix Biopharma, PCI Biotech, Oncoinvent and Ultimovacs will receive around 10 million NOK each over 4 years, depending on the outcome of the contract negotiations between the council and the company. 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 in turn trigger interest  from private investors.

On the Research Council`s website you may find the total list of all the 58 companies (in Norwegian) and read more about the funding from the BIA-programme.

BerGen Bio develops novel treatment for leukemia

Oslo Cancer Cluster member BerGenBio announce that preclinical studies on the agent BGB324 may be effective as new treatment for patients with drug resistant Chronic Myeloid Leukemia (CML). The data was presented in a poster at the Annual Meeting of the American Society of Hematology (ASH) early December.

It is estimated that CML accounts for approximately 10% of all new cases of leukemia. The disease originates from malignant stem cells in the bone marrow and ultimately spreads throughout the body developing into a rapidly progressive and almost uniformly fatal acute.

CML is now largely treated with targeted drugs called tyrosine kinase inhibitors (TKIs), which have led to improved long term survival rates and allow most patients to have a good quality of life when compared to the former chemotherapy drugs. Novartis’ Gleevec (imatinib) and Tasigna (nilotinib), and Bristol Myer Squibb’s Sprycel (dasatinib) are examples of these new targeted drugs.

Effective against drug resistance
However, long term therapy with the new treatment can result in the development of drug resistance and new mutations. BerGenBio’s preclinical in vivo studies shows that BGB324 may be effective as therapy taken alone, in leukemia and solid tumors, and is very effective in preventing and reversing acquired resistance to existing therapies.

The results are based on work conducted by Dr. Sonja Loges’ group at the University Comprehensive Cancer Center in Hamburg: “There is a significant unmet need for novel therapies that can address drug-induced resistant cancers”, comments Dr. Sonja Loges.

“The results of the preclinical studies support our belief that BGB324 could also offer a promising potential new treatment option for chronic myeloid leukemia, especially in patients that are resistant to the current standard of care.”

BerGenBio’s cancer drug BGB324 is the only selective Axl inhibitor in clinical development having recently completed a phase Ia clinical trial. Phase Ib clinical trials are planned in acute myeloid leukemia and non-small cell lung cancer in 2014.

Read the press release on BerGenBio’s website and the abstract in full on the American Society of haematology website.

About the Axl kinase receptor

Axl is a member of the Tyro3, Axl, Mer receptor (TAMR) tyrosine kinase family and is a fundamental receptor to cancer biology. It plays a crucial role in the epithelial-mesenchymal transition (EMT) which is a key driver of metastasis (cancer spread) and a mechanism of drug-resistance. The Axl receptor is regarded as one of the most promising new therapeutic targets for cancer drug development. BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase.

About BerGenBio AS
BerGenBio AS is a biopharmaceutical company located in Bergen, Norway and member of Oslo Cancer Cluster. The company is committed to developing first in class therapeutics that inhibit EMT, preventing the formation of cancer stem cells and disrupting the important mechanisms of acquired cancer drug resistance. The
company is founded on proprietary platform technology called CellSelect™, which uses information
from RNAi screening studies to identify and validate novel drug targets and biomarkers. BGB324 is
the first compound in BerGenBio’s pipeline to enter clinical trials, with additional compounds and drug
targets at different stages of preclinical development.