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Eniluracil/5-FU/leucovorin has promise to produce therapeutic advantages over iv 5 FU and capecitabine

Eniluracil inactivates dihydropyrimidine dehydrogenase (DPD), thereby preventing the formation of α fluoro-β-alanine (F-BAL), and conferring 100% oral bioavailability and a 5 hr half life on 5 fluorouracil (5 FU).  An open-label Eniluracil, 5-FU and leucovorin vs. capecitabine (4:3 randomization) Phase II trial for metastatic breast cancer is in progress. Study drugs are administered orally for 1st- or 2nd-line treatment for metastatic disease in patients previously treated with an anthracycline and a taxane. Arm 1: eniluracil/5-FU/leucovorin administered once/week for 3 weeks/4 weeks. Arm 2: capecitabine (1000 mg/m2) taken bid for 14 days/21days.  Arm 2 patients with disease progression could crossover to take eniluracil/5-FU/leucovorin in Arm X.  Eniluracil/5-FU/leucovorin has been active and well tolerated in both Arm 1 and Arm X.  The primary endpoint, progression-free survival, will be determined approximately 7.5 months after the trial is enrolled with 140 evaluable patients, expected in 2Q 2013.    

Xiber is a biopharmaceutical start–up company. Xiber develops new peptide drugs to improve outcome of critical care & transplant patients. Xiber’s peptide drugs preserve organ function & prevent organ failure. Xiber will enter market by two niche indications: Acute Lung Injury & Primary Graft Dysfunction after Lung Transplantation – with a total market volume of 630 Mio. USD.
In 2015 Xiber will complete the preclinical development for both indications. A phase I clinical trial will start in the beginning of 2016.
Xiber is a spin-off of the Medical University of Vienna. The majority of the shares is owned by the founders. The University holds a non-controlling interest and rewards its shares by providing cooperation, infrastructure, facility services and management support.
To drive its developmental program till the completion of a phase I trial Xiber needs ~ 4 Mio €. This is largely covered by Austrian funds and loans. For the remaining  Xiber seeks 2 Mio € equity from VC partner. Xiber has already signed a LOI with an established VC company. 

Corporate

• Ceronco Biosciences is developing new drugs to fight cancer based on the short-chain sphingolipid (SCS) technology discovered in a collaborative research project at the Netherlands Cancer Institute (NKI) and Erasmus MC.
• Proof of principle has been established in combining the SCS-technology with doxorubicin in highly relevant animal models. Addition of the SCS leads to increase in uptake of doxorubicin, specifically in cancer cells, and subsequently a significant reduction in tumor growth and increase in overall survival. At the same time no increase in severity of expected side effects or new side effects were noted.
• Ceronco is now taking this first product (CB001) into clinical trials, with expected start of the first clinical trial early 2013.

Technology

• A major barrier for uptake of chemotherapeutic drugs is the cellular membrane of a cancer cell. A new class of short-chain sphingolipids (SCS) has been identified which insert themselves into the cellular membrane and lead to catalysis of drug-membrane translocation. This results in increased uptake of a large variety of amphiphilic chemotherapeutic drugs.
• Tumor Cell Membrane Modulation using the SCS-technology is a novel and unique method to increase the efficacy of chemotherpaeutic drugs.

Products

• CB001: GluCer-enhanced liposomal doxorubicin
• CB002: SCS-enhanced mitoxantrone

DIGNA Biotech is a private biotechnology company headquartered in Pamplona (Spain), with offices in Madrid and Pennsylvania (USA). It was founded in 2004 as a spin-off of the University of Navarra. The firm currently has a pipeline of 9 products at different stages of development in 3 therapeutic areas: Inflammatory/Autoimmune, Cardiovascular and Liver diseases.

 Digna Biotech is seeking private funding to spin out a new biotech company to conduct Phase IIb and Phase III trials of its more advanced candidate, a cytokine inhibitor for the treatment of patients with Systemic Sclerosis and Localized Scleroderma. The product (Disitertide) has already completed Phase I, Phase IIa and open-label extension (OLE) clinical trials under a topical formulation in patients with systemic sclerosis. Orphan drug designation by both FDA and EMA has been granted in the two indications.