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

BusinessUK

20.08.2014 Biopharmaceutical contract manufacturer Fujifilm Diosynth Biotechnologies is expanding its cell culture manufacturing capacity further with a new 2,000l single-use bioreactor at the company’s site in Billingham, UK.

BusinessEUGermanyUK

15.08.2014 Some of Europe’s biggest pharma companies are competing in a bidding war for US biotech Intermune Inc., Bloomberg reports, citing insider reports as the source.

ResearchEUGermanyUK

13.08.2014 The Ebola epidemic is still raging on in West Africa and thus far there is

neither vaccine nor cure for the viral disease. The only flickers of hope:

an experimental antibody serum and an early-stage vaccine.

BusinessFrance

11.08.2014 Will Sanofi succeed where Pfizer failed? The French pharmaceutical company has taken on the commercialisation of Mannkind Corporation’s inhaled insulin product Afrezza.

ResearchSwedenGermany

08.08.2014 Boehringer Ingelheim is walking away from Swedish Orexo's prostaglandin inhibition project OX-MPI. Germany's largest researching pharmaceutical company had been responsible for the project's research and development since 2005.

ResearchSwitzerlandDenmark

06.08.2014 Roche is re-expanding its involvement in RNAi technologies. The Swiss pharmaceutical company will pay up to €335m for the acquisition of the Danish company Santaris Pharma A/S.

ResearchUKSwitzerland

03.08.2014 In its efforts to become the leading country in genetic research, the UK has attracted investments worth more than £300m (€376m) to map 100,000 human genomes by 2017.

BusinessSpainUKSweden

31.07.2014 Astrazeneca is buying the rights to Almirall’s respiratory drugs in a deal worth up to €1.56bn.

BusinessFranceGermanySwitzerlandUK

30.07.2014 Rumours have it that French Danone wants to sell its medical nutrition business to US drugmaker Hospira for US$5bn in yet another tax inversion deal.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • SANTHERA80.00 CHF6.74%
  • WILEX2.26 EUR1.80%
  • ADDEX4.07 CHF1.75%

FLOP

  • MOLOGEN7.30 EUR-6.41%
  • 4SC1.16 EUR-3.33%
  • EVOLVA1.27 CHF-2.31%

TOP

  • MAGFORCE6.47 EUR19.8%
  • SANTHERA80.00 CHF15.1%
  • LONZA101.50 CHF9.7%

FLOP

  • WILEX2.26 EUR-31.1%
  • MOLOGEN7.30 EUR-22.8%
  • VITA 343.79 EUR-19.9%

TOP

  • SANTHERA80.00 CHF3802.4%
  • CO.DON2.50 EUR228.9%
  • PAION2.41 EUR186.9%

FLOP

  • CYTOS0.27 CHF-93.3%
  • MEDIGENE4.60 EUR-66.4%
  • THERAMETRICS0.08 CHF-46.7%

No liability assumed, Date: 20.08.2014