BIOTA LANI PHASE III TRIALS READY FOR ENROLMENT
November 20th 2008 08:19
Monday November 17, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS DOWN: PHYLOGICA UP 56%, LABTECH DOWN 23%
* BIOTA LANI PHASE III TRIALS READY FOR ENROLMENT
* MEDICAL THERAPIES OFFERS SHARE PLAN AT 4¢ A SHARE
* CYTOPIA DOSES 1st PHASE Ib/II BRAIN CANCER PATIENT
* PROGEN SPIN-OUT PHARMASYNTH FOR SALE
* DR MERVYN JACOBSON INCREASES IN GENETIC TECHNOLOGIES
* FMR, FIDELITY REDUCES TO 9.7% IN CSL
To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au
BIOTA
Biota says the multi-centre phase III clinical trail of its long acting neuraminidase inhibitor CS-8958 is ready to begin patient treatment.
Biota said patients were expected to enrol into the study progressively throughout the Asian influenza season.
The company said the phase III multi centre study would be conducted in Japan, Taiwan, Hong Kong and Korea involving adult patients who have confirmed, naturally acquired influenza A or B.
A double blinded phase II trial in Japan concluded that inhaled CS-8958 administered once only was statistically indistinguishable from 75mg of oseltamivir (Tamiflu) administered twice daily for five consecutive days (see Biotech Daily; July 31, 2008).
Biota chief executive officer Peter Cook told Biotech Daily that a second arm of the phase II trial conducted in Taiwan remained open and would continue in parallel with the pivotal phase III trial.
Biota said in its media release the trial would use time to symptom resolution as its primary end point, after a single inhaled dose of CS-8958.
The double blind, non-inferiority study uses 75 mg of oseltamivir, twice daily for five days as its control.
Safety will be also assessed in the study.
A second phase II/III paediatric study will also be conducted in Japan on children less than nine years of age.
Biota said the paediatric study would use the same primary end point as the adult study, but using a control of 2 mg/kg of oseltamivir, twice a day for five days.
Biota said CS-8958 was a long acting neuraminidase inhibitor, discovered by Daiichi Sankyo and co-owned with Biota.
A total of $US5.6 million of Western clinical programs for CS-8958 have been or are intended to be funded by the US National Institute of Health.
Biota said the drug’s profile suggests that a single inhaled dose of CS-8958 should be efficacious for the treatment of influenza and an inhaled dose once a week, to maintain prophylaxis.
Pre-clinical tests have shown CS 8958 to be effective against influenza A & B virus as well as against the H5N1 avian influenza virus.
Mr Cook said that a Western phase I trial would be conducted and the results of that trial and the Japanese multi-centred phase III trial would be the basis of an investigational new drug application to the US Food and Drug Administration.
He said the Japan-based pivotal phase III trial could extend over two influenza seasons, depending on enrolments.
Biota climbed three cents or 7.5 percent to 43 cents.
To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au
| 8 |
| Vote |
Shared on
Add To: 
Subscribe to this blog
