adds broker comment

Xenetic Biosciences (LON:XEN) said today it had taken a pivotal step in establishing the company's new drug development centre in Boston with the appointment of Dr Henry Hoppe IV.

Dr Hoppe, a biotechnology drug development executive with over 20 years' experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies, will take become vice president of drug development.

Xenetic added that Dr Hoppe’s principal expertise lies in the processes surrounding regulatory submissions, IND filings and clinical trials, especially in the orphan and rare disease arena. 

He has written and reviewed IND/NDA CMC sections for numerous recombinant protein and gene therapy programs, including those for Cerezyme, Fabrazyme, Myozyme and Thyrogen, being four currently marketed products of the Genzyme Corporation, where he worked for 17 years.

Scott Maguire, Xenetic’s chief executive said:  "Henry's extensive drug development knowledge and experience gained during his years at Genzyme and his years as a leading consultant will be hugely valuable to Xenetic as we roll out our clinical programmes in the US and Europe."

Xenetic aims to use its new drug development centre to reduce its dependence on third party collaborators and commence clinical development in the West of its proprietary drug and vaccine pipeline.

The first two programmes to be moved into Western clinical trials will be ErepoXen, which offers an improved form of erythropoietin (EPO), and OncoHist, bio-therapeutic molecule for the treatment of tumours.

House broker Singer Capital adds that the Boston-based drug development centre will have a total of three to five staff and is primarily tasked with overseeing North America- based clinical trial. 

Last week, Dr Surender Kharbanda joined as a specialist consultant to accelerate the development of OncoHist.

Xenetic has recently explicitly broadened its focus to ‘Orphan Disease’, offering the prospect of shorter development timelines, less hefty clinical development costs, and a higher probability of successful development, the broker said. 

Importantly, the high value attributed to ‘Orphan’ candidates offers the potential of significant longer-term value to the stock. Hoppe’s skill in this area is likely to make a valuable contribution, Singer added.

The broker has a 'buy' rating and a sum-of-the–parts value for the shares of 17 pence.

Xenetic Biosciences (LON:XEN) said today it had taken a pivotal step in establishing the company's new drug development centre in Boston with the appointment of Dr Henry Hoppe IV.

Dr Hoppe, a biotechnology drug development executive with over 20 years' experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies, will take become vice president of drug development.

Xenetic added that Dr Hoppe’s principal expertise lies in the processes surrounding regulatory submissions, IND filings and clinical trials, especially in the orphan and rare disease arena. 

He has written and reviewed IND/NDA CMC sections for numerous recombinant protein and gene therapy programs, including those for Cerezyme, Fabrazyme, Myozyme and Thyrogen, being four currently marketed products of the Genzyme Corporation, where he worked for 17 years.

Scott Maguire, Xenetic’s chief executive said:  "Henry's extensive drug development knowledge and experience gained during his years at Genzyme and his years as a leading consultant will be hugely valuable to Xenetic as we roll out our clinical programmes in the US and Europe."

Xenetic aims to use its new drug development centre to reduce its dependence on third party collaborators and commence clinical development in the West of its proprietary drug and vaccine pipeline.

The first two programmes to be moved into Western clinical trials will be ErepoXen, which offers an improved form of erythropoietin (EPO), and OncoHist, bio-therapeutic molecule for the treatment of tumours.

Xenetic Biosciences (LON:XEN) said it and its partner, the Serum Institute of India, have dosed their first intravenous patient with ErepoXen, a potential long-acting treatment for anaemia.

In total 40 chronic renal failure patients will be treated as part of the six-month phase I/IIa trial. The study is designed to confirm safety and reductions in the frequency of dosage, Xenetic said.  

EPO, or erythropoietin, is a hormone produced by the kidneys that controls the production of red blood cells. It is also used in synthetic form by physicians to treat conditions such as anaemia. 

In the case of end stage renal disease patients, EPO is administered intravenously three times a week. 

Xenetic's ErepoXen has already demonstrated in phase I and II(a) clinical trials based on the subcutaneous method of administration that it has the potential to be a long-acting version with a likely dosing profile of once per month.

Xenetic chief executive Scott Maguire said: "The commencement of our IV patient trials in India with ErepoXen is an exciting step forward in combining the two methods of EPO administration.  

“We have previously announced positive Ph IIa subcutaneous results and now, with the intravenous trial, we cover the full $9 billion market potential of EPO. 

“We now have four drug candidates under clinical development with our partners including two via our recent acquisition of SymbioTec in Germany.

“Our aim is to fund ErepoXen through to an Food & Drug Administration phase IIa at which point we will seek to out-licence this candidate."