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."

Biopharmaceutical firm Xenetic Biosciences (LON:XEN) reported this morning that it had completed the subscription agreement it arranged in August to raise £12.2 million.

Xenetic deal’s with SynBio – a Russian drug development company – was to raise £12.2 million in exchange for 110.8 million shares in Xenetic at 11 pence each (which represents a premium of 69.2 per cent to Xenetic’s closing price yesterday).

The firm also revealed in August that it would be buying German firm SymbioTec – a developer of technology that uses highly-alkaline proteins to treat a broad spectrum of cancers. Today, it said that it expects the completion of this acquisition will occur no later than December 15.

“The company now has the capital to accelerate its drug development pipeline and, in our view, significantly enhance shareholder value,” said M. Scott Maguire, Xenetic’s chief executive officer. “Our primary focus will be on the positive human clinical data that is being generated by our partnerships in Russia and India, thereby providing comfort on the drug candidates' potential for success.”

Maguire added that the firm’s de-risked approach to biotech development “is exemplified through the 12 novel drug candidates under the Russian and Indian human proof of concept initiatives” and that this, combined with the potentially large number of additional new candidates that can be developed using the firm’s platform technologies, “is expected to yield significant shareholder value going forward”.

In August Xenetic struck a deal with SynBio – a Russian drug development company – to raise £12.2 million in exchange for 110.8 milion shares in Xenetic at 11 pence each. It also revealed that it would be buying German firm SymbioTec – a developer of technology that uses highly-alkaline proteins to treat a broad spectrum of cancers.

The transfer of 34 million Xenetic shares to SynBio is a transfer that must be appropriately registered with the relevant authorities in the Russian Federation, the firm said. After completion of the registration process, Rusnano will inject cash funding into SynBio that will enable it to complete its subscription agreement with Xenetic by subscribing for the 110.8 million Xenetic shares.

The target date for the completion of the subscription agreement is now expected to be November 25. However, the firm stressed that achieving this date is dependent on the speed with which the registration process can be effect in Russia.

The acquisition of SymbioTec is intended to occur around the same date, but Xenetic said it had made provision so that it could occur by December 15 at the latest.

“The transactions involved in what is a complex set of deals spell a new beginning for the company as they enable us to implement our strategy of de-risking biotech,” said Scott Maguire, Xenetic’s chief executive officer. “With the new co-development Agreement with SynBio, we will have 12 drug candidates in various stages of development in Russia and India via licenses. The data generated by our partners will give human proof of concept on the drug candidates' merits as a therapy, thus taking a large element of the risk out of drug development and allowing us to decide which drug candidates have a good chance of success before we allocate our newly acquired cash resources to US and European clinical trials.”

Biopharmaceuticals firm Xenetic Biosciences (LON:XEN) said it is continuing to work with partners to close a number of transactions announced last month that are designed to transform the company.

In August Xenetic struck a deal with SynBio – a Russian drug development company – to raise £12.2 million in exchange for 110.8 milion shares in Xenetic at 11 pence each. It also revealed that it would be buying German firm SymbioTec – a developer of technology that uses highly-alkaline proteins to treat a broad spectrum of cancers.

These transactions were due to be closed by September 30, but Xenetic said today that, although it and its Russian and German partners have fulfilled their respective contractual obligations,  process delays have occurred in both Russia and Germany such that closing by today is now not possible. The firm added that the closing of the transactions is now expected to take place during the second half of October.

“In spite of there being a modest delay in this matter, the transactions represent a pivotal deal for the company – to say nothing of their importance to the Russian State in developing their global biotech industry,” said M. Scott Maguire, Xenetic’s chief executive officer. “Consequently all parties will continue to work assiduously to achieve closing as soon as practically possible.”

The biopharmaceuticals group Lipoxen (LON:LPX) revealed today very encouraging phase II trial results for its long-acting EPO candidate ErepoXen.

ErepoXen is being developed as a long acting form of EPO for the treatment of anaemia in renal disease patients. 

It uses Lipoxen's proprietary PolyXen drug delivery technology which improves the efficacy, stability and half life of protein drugs and reduces risk of toxicity.

The phase IIa study carried out in India on 30 men and women with chronic kidney disease showed the drug successfully increased and maintained the reticulocyte count for a period of 28 days.

“This finding suggests the drug may be effective when administered once monthly to patients with chronic kidney disease, thereby achieving maximal compliance and excellent outcome results,” Dr Ashraf Mikhail, consultant nephrologist at the Morriston Hospital in Wales and senior clinical tutor at Swansea University.

He reviewed the study findings, which are the result of a partnership with the Serum Institute of India, the sub-continent’s largest biotechnology firm.

The pair will now consider the optimum development path for the commercialisation of ErepoXen.

This might include entering Phase II(b) trials in India as well as the possible out-licencing of the compound to a commercial collaborator.

The study also found that the drug was well tolerated and safe at all doses used.

For the study patients received by a doses of either 0.5µg/kg, 1µg/kg or 2 µg/kg ErepoXen via a single injection.

“The study confirms the findings of phase I trial,” Mikhail said.

“Polysialylated EPO is effective in increasing the reticulocyte count and thereby stimulating erythropoiesis in patients with Chronic Kidney Disease in a dose dependent manner. 

“The rise in reticulocyte count is maintained for up to 28 days after a single injection.”

ErepoXen is one of two key developments in the Lipoxen portfolio. The other is SuliXen, a long-acting insulin, which is being developed by Russian partner FDA Pharma.

Lipoxen's (LON:LPX) drug development plans are set for a boost after its partner, Pharmsynthez, raised £10.7 million with an IPO onto the Moscow Central Stock Exchange (MICEX).

Pharmsynthez intends to use the new cash to fund its development programs to help speed up the launch of its products in Russia.

Lipoxen has three novel drug platforms that targets three specific areas – biological (PolyXen), vaccines (ImuXen) and oncology.

Lipoxen and Pharmsynthez are currently developing 6 drugs - 3 PolyXen and 3 ImuXen candidates - through a collaborative partnership. 

“The funds raised by Pharmsynthez will be used to deliver their ambitious investment programme which will accelerate their growth,” Lipoxen chief executive Scott Maguire said, “and enable them to introduce their unique pharmaceuticals to the Russian as well as international markets.”

Maguire adds: "We have encouraging pre-clinical data on the Multiple Sclerosis vaccine candidate and we are still confident that this will be the first of the projects to reach the clinical trial stage early in 2011."

The current development programme aims to deliver ‘human proof of concept’ data and Lipoxen remains hopeful that a number of potential candidates will be justify further development in the clinic.

Pharmsynthez is only the second biotech stock listed on the MICEX.

The company now looks to capitalise on that success and accelerate the candidate into phase 1 clinical trials within 24 months.

The update was welcomed by investors, and shares in the company were up 3.85% by midday, at 6.75 pence.

In April last year Lipoxen announced positive clinical data for its proprietary influenza vaccine candidate, noting that the ImuXen technology platform as applied to an influenza vaccine had increased the effectiveness of influenza vaccines about 30-fold.

The technology also has the potential to “radically” increase output of vaccine doses from manufacturing facilities to confer an advantage of up to 10 times existing vaccine production rates, while avoiding the need for "cold chain" storage and distribution as it is stable for long periods in high temperatures in its dried form.

At that time, the company said it would be necessary to undertake further studies to validate the advantages delivered by a novel influenza vaccine produced using ImuXen.

The studies were focused on economies of production through the use of less antigen, the ability to confer single-shot immunity and he ability to deliver a cost effective and storage and handling stable product that can be effectively dosed in tropical and sub-tropical climates.

According to Lipoxen, the latest project results validated all of the major benefits that were announced in April 2009.

It said that the ImuXen platform allowed the development of multi-valent vaccines with the potential to meet the demands of therapeutic efficacy and cost effectiveness, helping the governments to reduce the cost of public healthcare.

Lipoxen has moved directly to seek EU grant funding to undertake a full good manufacturing practice (GMP) manufacturing and goold laboratory practice (GLP) toxicity, safety and efficacy programme ahead of its planned route to phase 1 studies.

Lipoxen has targeted the submission of its clinical trial application for Q4 2012, subject to the availability of capital.

“We are now actively taking steps to commercialise this opportunity in parallel with seeking EU grant funding to take this important proprietary product into the clinic as soon as possible.

“I believe that these results put Lipoxen firmly on the map as a leading European platform technology company with the potential to offer a full range of delivery solutions for both biologic and vaccine therapies, be this for next generation drugs and vaccines or for patent protected bio-superior products,” said chief executive of Lipoxen Scott Maguire.

Lipoxen hopes that ImuXen will “sit alongside” its PolyXen technology, which has already shown significant potential in both clinical trials and with its main commercial collaborator Baxter Healthcare.

Lipoxen has three proprietary patented technology platforms, including PolyXen, ImuXen and SiRNAblate.

Last month, Lipoxen renegotiated its agreement with Baxter Healthcare (NYSE:BAX). Under the new terms, the company will receive a US$2 million licence fee. In addition to that, the AIM-listed group is also issuing warrant rights to subscribe to US$2 million of new equity between July next year and June 2015.

Lipoxen will also get US$71 million of milestone payments and royalties instead of the US$75 million negotiated in 2005.

Broker Singer Capital Markets welcomed the news, saying that it added further validation to Lipoxen's technology platform.

According to Lipoxen, the patent expansion strengthens and broadens its existing ImuXen patents - which protect the co-delivery DNA and antigen and delivery of antigen alone.

"This Patent extension is important as it further protects the patent position of our gene vaccine technology”, Lipoxen chief executive Scott Maguire commented. “Such added protection will provide value to commercial partners seeking long term exclusivity in the vaccine market".

Lipoxen's proprietary ImuXen technology uses lipids, natural substances found in the human body, to entrap active ingredients - like antigens - to ensure direct delivery into the appropriate cells of the immune system.

According to Lipoxen, the use of the technology results in enhanced immune responses, which could potentially lead to single dose immunity being achieved, while reducing the side effects associated with traditional vaccines.

The new Patent protects the use of a range of additional cationic lipids that can form the building molecules of Lipoxen's ImuXen liposomes.

Recently, towards the end of April, Lipoxen received positive results for two of its ImuXen proprietary candidates, one developed as a novel influenza vaccine and the other as a malaria vaccine.

In terms of ImuXen’s influenza vaccine, Lipoxen has completed initial pre-clinical development, and it has successfully developed a number of viable vaccine candidates, which it believes are likely to "induce effective immunity against influenza".

Lipoxen said it will now complete live influenza virus challenge studies using recognised and validated in vivo (‘in living organism’) models. 

The company also emphasised that the candidates' ‘thermo-stable’ properties will also be investigated, as it is expected that they will not require refrigeration – potentially solving a significant distribution and storage issue for modern vaccines.

Separately, Lipoxen has completed the experimental phase of its malaria vaccine project, in association with PATH MVI. The company said it has delivered the formulation which utilizes Lipoxen's ImuXen technology to enhance the delivery of malaria antigens to the immune system.

"Preclinical tests revealed that anti-malaria antibodies were increased 10 fold using the liposomal co-delivery platform compared to the antibody response to a mixture of antigen-coding DNA plus protein antigen.  In addition, malaria antigen-specific CD4+ T cells were detected," Lipoxen stated.

Lipoxen noted that whilst MVI has decided not to commit additional funding to the project, Lipoxen believes that the programme has further demonstrated the validity of the ImuXen platform, and it intends to seek a commercial partner to take this novel platform into clinical development.

The biopharmaceutical company, has three proprietary patented technology platforms. In addition to ImuXen, Lipoxen has also developed PolyXen, which is used to extend the efficacy and half life of biologic drugs, and SiRNAblate is a delivery platform for siRNA which stands for small interfering RNA, sometimes known as short interfering RNA or silencing RNA.

Also in April, Lipoxen announced it secured the necessary funding to move forward with its development programme, for its proprietary product pipeline, after conducting a successful placing to raise £1.2 million. The shares were placed at 7 pence per share compared to the stock’s yesterday’s closing price of 7.13 pence.

The company also told investors that it expects its project base to return significant license fee income going forward.

CEO Scott Maguire purchased 100,000 shares at 6.95 pence per share to take his stake in the company to 0.82%, or 1,401,362 shares, while CFO Colin Hill bought 150,000 shares for 6.83 pence per share, upping his interest to 1.06% of the capital, or 1,825,420 shares.

In its full year report released at the start of this month, the company said it expected its project base to return significant license fee income going forward. It noted that the license deals that have been pushed out from 2009 to 2010, leading to declines in revenues last year, still had the potential to deliver revenues in the near term.

The management is looking to focus on developing its proprietary product pipeline and securing income from license deals, while reducing its pure research activities. Lipoxen has already secured the necessary funding to move forward with its development programme after conducting a successful placing to raise £1.2 million.

Its main directors took part in the placing announced earlier this month, with executive chairman Sir Brian Richards taking up 1,071,429 Lipoxen shares and raising his holding to 2,262,606 shares, or a 1.32% stake. Maguire and Hill each took  535,714 shares in the financing, increasing their respective holdings to 1,301,362 and 1,675,420 shares.

Other post-period events included the granting of a new US patent for PolyXen technology, the dosing of first patients in an FDA/EMEA regulated Indian Phase II trial of ErepoXen and the granting of patients for Polysialylated G-CSF StimuXen Technology in six European countries.

Investors reacted positively to the further endorsement by managers, sending shares up more than 9%.