DEADLINE EXTENSION: Submission deadline 30 September for PanACEA Postgraduate Programme

We are pleased to announce the opening of our Postgraduate programme, which will offer candidates a unique opportunity to support PanACEA objectives and obtain a research degree. The research programmes will be sponsored by expertise core and other affiliated resources. Candidates will be matched to appropriate projects based on their scientific interests, experience and acumen.

To apply, the Postgraduate Application Form (below or click here) must be submitted, which consists of two parts (Part A and B). First, candidates must fill out Part A of the form. In Part B a statement of support must be supplied by a principal investigator (PI)/other referee.*

Closing date for submission: Sunday 30th September 2018 at 23:59 Greenwich Median Time (UK Time)

For further information or assistance, please contact Prof Tim McHugh (t.mchugh@ucl.ac.uk) and or Lavinia Rodney (l.rodney@ucl.ac.uk).

Upon application, the principal investigator (PI)/other referee will be contacted via email to also provide projects for this scheme (Part C)

 

 

Postgraduate Application Form

Part A: Applicant to fill out
Part B: Principal investigator (PI)/other referee

 

New EDCTP Project Officer

As of June the PanACEA consortium welcomes Jean Marie Habarugira as the new EDCTP Project Officer. At the General Assembly meeting on June 11th the consortium had the first opportunity to get acquainted with him and an official visit will follow. Jean Marie Habarugira has been working for the EDCTP as Project Officer since 2010. To get to know him better, go to: http://www.edctp.org/get-know-us/people-edctp/edctp-secretariat/jean-marie-vianney-habarugira/

Jean Marie Habarugira is replacing Monique Rijks-Surette, who is leaving EDCTP to start a position at Johnson & Johnson. We enjoyed the pleasant cooperation and wish her all the best in the new challenges ahead.

GA Conference V

Building up to this quarterly General Assembly (GA) meeting on June 11th the Expertise Cores developed a comprehensive trial capacity development proposal. The Cores are eager to start and the General Assembly gave the final go-ahead for their plans.

PanACEA is one year into the project now and an Annual Report was submitted to its funder, the EDCTP, on behalf of the consortium. The Coordinator reported on the progress of the project, activities for capacity development and dissemination of scientific results/achievements.

Other items on the agenda of the GA were the HR1, trial that is coming to an end, and the upcoming trials for which the preparations are under way.

Ifakara Health Institute

Ifakara Health Institute
Bagamoyo Research and Training Center (BRTC)
PO Box 74
Bagamoyo, Coast Region
TANZANIA

Project Leader: Dr. Francis Mhimbara
Principal Investigator:
Dr. Lilian Tina Minja
Contact: Dr. Francis Mhimbara and Dr. Lilian Tina Minja
Phone: +255 754 291657 / +255 713 254563
Website: www.ihi.or.tz

16.5 Million Euro for PanACEA II

Rob Aarnoutse, Leon van Halder, and Martin Boeree signing the PanACEA II Grant Agreement

PanACEA II has been granted 16.5 million euro in their drug development programme to shorten and simplify treatment of tuberculosis. On February 24th 2017, the coordinating team from Radboudumc Nijmegen, Martin Boeree and Rob Aarnoutse, have signed the PanACEA Grant Agreement with Radboudumc’s chairman of the board of directors, Leon van Halder. On February 27th, the European and Developing Countries Clinical Trials Partnership (EDCTP) has countersigned the agreement which results in the project’s official start on March 1st 2017.

Building on PanACEA I, the objectives of PanACEA II are to complete the optimization of existing drugs and to evaluate two novel agents. Combination regimens will be tested that will shorten and simplify treatment for both drug-sensitive and drug-resistant tuberculosis. Trials will be conducted at 11 sites throughout sub-Saharan Africa, empowering African scientists in all aspects of an integrated and comprehensive programme for drug development. The capacity development programme, which stems from PanACEA I, will be expanded to strengthen African clinical trial sites and research capacity and to strengthen and transfer African scientific leadership.

The PanACEA II consortium will have their first official meeting on 7 and 8 March 2017 in Cape Town.

 

 

PanACEA in The Lancet Infectious Diseases

On October 26th, 2016 The Lancet Infectious Diseases published the most recent findings from the multi-arm, multi stage tuberculosis (MAMS-TB) trial of the PanACEA consortium. The MAMS-TB  trial investigated four new potential regimens for the treatment of tuberculosis.

Trial results show that the highest rifampicin dose tested (35 mg/kg) is safe and reduces the time to culture conversion in liquid media compared to the standard dose (10 mg/kg). The 35 mg/kg dose has promise to progress to phase 3 as an important component of future, shorter regimens to be assessed for improvement of relapse rates.

The data bring into question the utility of regimens with relatively low increases in the dose of rifampicin, suggesting that they are not likely to provide significant benefit or treatment shortening. In this light, the results suggest that higher doses than 35 mg/kg should also be evaluated for safety and efficacy.

Finally, this is the first time that a multi-arm adaptive trial design was successfully implemented in a multi-centre study in a high tuberculosis burden setting. This approach might accelerate tuberculosis regimen development at a reduced cost.

First Session PanACEA II in Liverpool

The preparations for PanACEA II have been in full swing with a meeting of a large part of the consortium in Liverpool. On October 26th 2016, the international group of partners met again to share thoughts and ideas about the continuation of PanACEA. Several presentations were held, results were shared and organisational issues were discussed.

 

PanACEA MAMS-TB-01 finds high-dose rifampicin may help shorten TB treatment

Press release – Nijmegen, Netherlands / Munich, Germany February 26th 2015:

At the annual Conference on Retroviruses and Opportunistic Infections (CROI), PanACEA, the Pan-African Consortium for the Evaluation of Antituberculosis Antibiotics, presented the results of its most recent phase IIb study (MAMS-TB-01). The most exciting finding from the study is that high-dose rifampicin results in faster killing of TB bacilli during treatment, compared to the current standard treatment.

The standard WHO-recommended TB treatment regimen (2 months of daily ethambutol, isoniazid, rifampicin and pyrazinamide followed by 4 months of daily isoniazid and rifampicin (2EHRZ/4HR)) involves taking the drugs daily for 6 months. This can make adherence to treatment hard, and has substantial costs to the health system and patients. Shortening the length of time treatment needs to be taken for, may help to reduce the burden on health systems, the costs of treatment, and make treatment easier for patients. PanACEA MAMS-TB-01 was set up to address this.

High-dose (35mg/kg) rifampicin, in combination with standard dose of isoniazid, pyrazinamide and ethambutol, showed a significant shortening of time to culture conversion with a covariate-adjusted hazard ratio of 1.75, 95% confidence interval (1.21-2.55) over the 12 weeks of experimental treatment. For comparison to previous TB trials, covariate-adjusted hazard ratios compared to control over 8 weeks were 1.99, 95% confidence interval (1.21-3.29). It was not possible to culture TB bacilli in sputum by 8 weeks in 56% of patients on the 35mg/kg arm compared to 42% of patients on the standard of care arm. These proportions were 80% and 70% respectively after 12 weeks.

Culture on solid media, which was a secondary endpoint, showed a similar although less marked result.

Chief Investigator Martin Boeree (Radboud University Nijmegen) says: “This is the largest reduction in time to culture conversion seen in any previous TB trial, to our knowledge. High doses of rifampicin may be an important component in shorter TB regimens in the future.”

The arm containing moxifloxacin with rifampicin 20mg/kg, pyrazinamide and ethambutol showed a borderline significance, hazard ratio 1.42 (95% confidence interval, 0.98-2.05) for improvement over control.

In an interim analysis conducted in early 2014, recruitment to both arms that included the new drug SQ109 were terminated, as it was clear that both regimens would not meet the predetermined hazard ratio of 1.8 using liquid culture and thus were unlikely to result in substantially improved regimen. Patients on these arms remained on treatment and in follow-up, and the now available data confirms the interim analysis decision.

Preliminary analysis of safety events showed no differences in side-effects in any of the arms as compared to control.

The MAMS-TB-01 trial enrolled 365 patients from 7 sites in Tanzania and South Africa in only 11 months. It used an innovative adaptive clinical trial design that allows several new regimens to be compared to the current standard, and incorporates interim analyses that allow for regimens that show little treatment shortening potential to be excluded from the trial at an early stage.

Data on treatment up to week 26 and post-treatment follow-up will be analyzed and reported together with the results mentioned above in the main publication.

“We would like to thank our main donor, the EDCTP, for its support of this African-European consortium,” said Michael Hoelscher, sponsor representative. “We are pleased to have optimized one potential component of a future treatment-shortening regimen. This is, however, only the beginning of a series of phase I and II studies that will evaluate in a systematic manner at least 5 novel and improved TB drugs.“

Link to CROI Webcast: http://www.croiwebcasts.org/console/player/25685?mediaType=slideVideo&

Final PanACEA I Meeting in Alpbach, Austria

On January 25 – 28 the final PanACEA I meeting was held in Alpbach, Austria. PanACEA members of 11 countries (Belgium, Gabon, Germany, Great Britain, Kenya, Mozambique South Africa, Tanzania, The Netherlands, Uganda, and Zambia) attended the meeting. The newest results of the clinical studies, master and PhD studies and capacity development updates were presented.