News

Symphogen meets Phase II endpoints
Enlarge image

Clinical TrialsDenmarkPolandSweden

Symphogen meets Phase II endpoints

23.08.2012 - Danish Symphogen has published positive study results with the first recombinant polyclonal antibody therapy ever tested in clinical trials.

Results of an open-label, dose-escalation Phase II study including 61 patients with primary immune thromocytopenia (ITP) suggest that  a single injection of rozrolimupab (SYM001) is safe and boosts platelet counts significantly (Blood). In doses ranging from 75-300µg/kg the recombinantly produced mixture of 25 fully human anti-Rhesus D (RhD)-specific antibodies induced mild adverse effects in up to 20% of the volunteers, mostly headache (20%) and pyrexia (13%). In 8 out of 13 patients (62%), Symphogen’s lead drug induced an increase in platelet counts of at least 20x109/L after 72 hours that persisted for seven days after injection. Median time to response was 59 hours and the median duration of response was 14 days.

Lead investigator Professor Tadeusz Robak, from Lodz University said: “These phase II results suggest an efficacy and safety profile similar to that seen with plasma derived immunoglobulin products. Rozrolimupab can be produced indefinitely and may represent a novel and convenient replacement for blood-derived immunoglobulins with more limited supply.” Kirsten Drejer, Symphogen chief executive officer, added: “The multicenter study included involvement of the regulatory authorities of the USA, Europe and Asia, and we are confident that antibody mixtures represent a viable new class of antibody therapeutics offering well-characterized and potentially more efficacious alternatives to existing treatments.”

Symphogen’s rozrolimupab is the first human recombinant mixture of 25 antibodies which has been clinically tested. The mixture is manufactured simultaneously from a single batch, mimicking the natural diversity of the human antibody response.  Sym001 is being developed as an alternative to existing anti-RhD hyperimmune immunoglobulins for the treatment of Idiopathic Thrombocytopenic Purpura (ITP) and the prevention of Hemolytic Disease of Newborns (HDN). Sym001 is being co-developed with Swedish Biovitrum AB. Idiopathic Thrombocytopenic Purpura is an autoimmune bleeding disorder caused by abnormally low platelet levels, making it difficult for the blood to clot normally. Hemolytic Disease in Newborns is a Rhesus D-negative woman becoming sensitive to RhD during the pregnancy with or delivery of a Rhesus D-positive child. This immune reaction may trigger a maternal antibody response in subsequent RhD-positive pregnancies, causing the breakdown of fetal red blood cells.

http://www.european-biotechnology-news.com/news/news/2012-03/symphogen-meets-phase-ii-endpoints.html

FinancingFrance

21.10.2014 Yet another European company is looking for money on the US stock exchange – French DBV Technologies SA is all set up for its secondary listing on NASDAQ. The French biotech company hopes to rake in US$98m for its peanut allergy patches.

FinancingDenmark

18.10.2014 After raising US$220.5m (€172m) with its IPO, fast Forward Pharma’s lucky streak hits an obstacle on the road to success with shares falling 17% on its first day of trading.

M&AUKItaly

17.10.2014 Abandoned at the altar: Abbvie has dropped plans to acquire UK’s Shire following new US tax rules. This puts a stop to one of the biggest pharma mergers planned this year.

FinancingUKBelgium

15.10.2014 Bicycle Therapeutics wins €25m backing by major pharma venture capitalists for the development of a new class of oncology drugs.

FinancingGermanySwitzerlandNetherlands

13.10.2014 Biotechnology IPOs are back in fashion – German Probiodrug AG wants to raise €32m with its IPO, whilst Swiss Molecular Partners AG hopes the launch of its IPO will gain a revenue of €145m.

BusinessIreland

10.10.2014 Actavis has announced plans to merge with American pharma company Durata - a move that will strengthen their infectious diseases portfolio.

RegulationEU

07.10.2014 In an unprecedented move, the European Medicines Agency has approved a system allowing the future analysis of clinical trial data.

FinanceNetherlandsEU

06.10.2014 Another fund from the Netherlands has raised €92m in its first close and will invest the money in companies developing innovative therapeutics, medical devices and diagnostics.

FinanceNetherlandsUKSwitzerland

03.10.2014 Dutch venture capitalist LSP has achieved its monetary milestone by raising €80m for its fifth fund - with a goal of €150m.

PoliticsEULithuaniaPoland

02.10.2014 New EU commission chief Jean-Claude Juncker is on the defensive after members of Parliament and NGOs criticised his reorganisation of the health technology units.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • MEDIGENE3.85 EUR8.15%
  • EVOTEC2.87 EUR7.49%
  • 4SC0.84 EUR5.00%

FLOP

  • CYTOS0.15 CHF-6.25%
  • EPIGENOMICS3.42 EUR-0.87%
  • STRATEC BIOMEDICAL37.50 EUR-0.87%

TOP

  • BIOFRONTERA2.91 EUR32.3%
  • ADDEX3.44 CHF7.8%
  • HBM86.00 CHF4.4%

FLOP

  • PAION2.19 EUR-32.8%
  • CYTOS0.15 CHF-28.6%
  • 4SC0.84 EUR-25.0%

TOP

  • SANTHERA82.00 CHF2184.1%
  • CO.DON2.82 EUR200.0%
  • PAION2.19 EUR157.6%

FLOP

  • CYTOS0.15 CHF-96.2%
  • 4SC0.84 EUR-51.7%
  • THERAMETRICS0.07 CHF-50.0%

No liability assumed, Date: 22.10.2014