Press releases

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Additional information: Cyxone to explore options for faster market approval

Due to the interview conducted with Cyxone's CEO by BioStock/Monocl on Thursday, September 28, the company wishes to clarify references made about the extent to which two Phase 2 trials may be equated with a Phase 3 trial.

The regulatory framework relating to drug trials exists to ensure that development companies present significant and reproducable results involving candidate substances so that effectiveness and safety are established using the best scientifc methods prior to a company being able to market a product.

In certain cases it is possible that if two or more Phase 2 trials are conducted in the same way, the results from two trials may be considered as a single trial in statistical terms. It is the responsibiltiy of drug agencies to evaluate whether this can be permitted.

If drug agencies deem the combined analysis of several trials to be the equivalent of a larger follow-up trial, (so called Phase 3), and that the results are sufficiently strong to justify this, this may constitute sufficient grounds to submit an application to authorities responsible for marketing rights.

In the interview with BioStock/Monocl, Cyxone's CEO said that it was possible that Rabeximod may fall into this category, and that Cyxone intends to establish a dialogue with drug agencies at a later date. Prior to that, the company needs to conduct a six-month toxicity study followed by a new Phase 2 trial.

October 5, 2017

Contact
Cyxone AB (publ)
Kjell G. Stenberg, CEO
Tel: +46 (0)723 816168
Email: kjell.g.stenberg@cyxone.com
Adelgatan 21
211 22 Malmö
www.cyxone.com

This is information that Cyxone AB is required to publish under the EU Market Abuse Directive. The information was provided under the auspices of the above contact person for publication on October 3, 2017 at 11:55 CET. Press release Cyxone AB (publ) 559020-5471 October 5, 2017

About Cyxone
Cyxone AB (publ.) is a biopharmaceutical company that develops drugs based on cyclotides, a class of natural plant protein. Cyclotide technology has the potential to provide new drugs with beneficial pharmacological effects on diseases that currently lack safe and effective treatments. The company is focusing on the development of substances that inhibit key processes in cells that are typically associated with various immune disorders, such as multiple sclerosis and rheumatoid arthritis. Cyxone's Certified Adviser on the Nasdaq First North is Erik Penser Bank, which can be reached on +46 (0) 8 46 38 000. www.cyxone.com

November 23, 2017
Regulatory

Shareholders in Cyxone AB (publ.), 559020-5471, are hereby invited to an extraordinary general meeting at Setterwalls Advokatbyrå AB, Stortorget 23, in Malmö, on Monday, December 11, 2017 at 10:00AM.

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November 23, 2017
Regulatory

As previously announced, Cyxone acquired Rabeximod from OxyPharma in June 2017. Rabeximod has undergone Phase 2 trials in patients with moderate to severe rheumatoid arthritis in which significant improvements in the condition's symptoms were discovered four weeks after the completion of the formal (12 week) trial period.

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November 06, 2017
Regulatory

Cyxone has analysed the Rabeximod that was previously manufactured by OxyPharma for clinical trials at Syntagon AB. Results show that the existing substance, despite having been stored for several years, can be used in Cyxone's upcoming Phase 2b study in patients with rheumatoid arthritis.

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October 26, 2017
Regulatory

Summary

Period (July 1 to September 30, 2017)

  • Operating revenue KSEK 0 (0)
  • Income after financial items KSEK -1,518 (-1,235)
  • Earnings per share SEK -0,10 (-0,10) Cash and cash equivalents as of September 30 KSEK 25,662 (23,468)
  • Equity ratio as of September 30 95.2% (97.7%)

Period (January 1 to September 30)

  • Operating revenue KSEK 0 (0)
  • Income after financial items KSEK -5,593 (-2,860)
  • Earnings per share SEK -0,36 (-0,22)
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October 26, 2017
Regulatory
In co-operation with Taiwan-based Eurofins Panlabs Discovery Services, Cyxone has investigated whether T20K has the capacity to influence receptors or other cellular functions to shed light on the substance's potential side effects.
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October 13, 2017
Regulatory

In collaboration with the Medical University of Vienna, Cyxone is set to conduct a study into inflammatory bowel disease involving a cyclotide in established animal models. The study will begin early in 2018.

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October 06, 2017
Regulatory

Cyxone has licensed patent applications at various stages of approval in Europe, North America and Australia. In the US, our patent is approved and in other markets patent applications are well on the way to being approved. In Australia, our patent application was accepted in July, since when the company has submitted a final version and paid the required approval fee. 

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October 05, 2017
Regulatory

Due to the interview conducted with Cyxone's CEO by BioStock/Monocl on Thursday, September 28, the company wishes to clarify references made about the extent to which two Phase 2 trials may be equated with a Phase 3 trial.

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October 05, 2017
Regulatory

The subscription period to purchase warrants in TO 2 ended on September 29, 2017, and during the period, 2,467,119 warrant options were exercised for the equivalent number of shares, corresponding to a subscription ratio of around 98.7%. Cyxone thereby receives some SEK 12.3 million before issue costs.

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