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

ResearchUK

30.01.2015 AstraZeneca has joined forces with four research collaborations to use breakthrough CRISPR gene editing technology across its drug discovery platform.

Stock marketsEU

29.01.2015 Denmark's Ascendis Pharma has successfully raised US$108m with its upsized NASDAQ IPO, while Irish animal health specialist Nexvet is waiting in the wings.

Contract ResearchEU

28.01.2015 EMA recommends suspending around 750 generic medicines marketed throughout the world after India’s GVK Biosciences is accused of faking bioequivalence studies. Meds considered critically important for patients will remain available.

RegulationEU

21.01.2015 The EMA is asking for comments on how to implement the transparency rules of EU Clinical Trial Regulation, pointing to the new clinical trial portal and database as the main instrument.

Stock marketsEUGermany

21.01.2015 2014 was a record year for biotech companies on the European stock market, with a total of €2.4bn raised in the year - 25% more than in the year before.

ResearchEUUK

20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck. 

Stock ExchangeUKDenmarkFrance

16.01.2015 It's time to get used to weekly IPO plans by European biotechs. UK's drug discovery firm Redx Pharma Ltd, established just five years ago, has come of age with their £80m (€105m) IPO plans.

M&ASwitzerland

14.01.2015 Pharma kingpin Roche has launched a billion-dollar transaction for a total of US$1.2bn (€1bn), taking over the majority of US cancer specialist Foundation Medicine.

PoliticsEU

14.01.2015 The European Parliament has backed the legislation allowing individual countries to restrict or prohibit the cultivation of genetically modified crops that have been authorised at EU level.

M&AIrelandUK

13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • CYTOS0.36 CHF9.09%
  • FORMYCON15.48 EUR8.25%
  • MAGFORCE5.18 EUR3.39%

FLOP

  • BB BIOTECH244.15 EUR-4.91%
  • CO.DON2.34 EUR-2.50%
  • MORPHOSYS76.24 EUR-1.78%

TOP

  • CYTOS0.36 CHF56.5%
  • FORMYCON15.48 EUR53.6%
  • ADDEX3.28 CHF41.4%

FLOP

  • BIOFRONTERA1.93 EUR-16.1%
  • ACTELION100.80 CHF-13.3%
  • MOLOGEN5.75 EUR-9.4%

TOP

  • SANTHERA105.00 CHF2544.8%
  • WILEX1.96 EUR168.5%
  • FORMYCON15.48 EUR103.7%

FLOP

  • CYTOS0.36 CHF-90.1%
  • 4SC0.84 EUR-49.7%
  • MOLOGEN5.75 EUR-49.7%

No liability assumed, Date: 30.01.2015