Phosphagenics fills Phase 2 acne trial enrolment

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THE ROADHOUSE PHARMACY: Phosphagenics Limited (ASX: POH) has completed enrolment for a Phase 2 clinical trial of the company’s improved treatment for the common skin disorder acne vulgaris.

The three month study is examining the efficacy of the topical acne drug tretinoin, which has been formulated with Phosphagenics’ proprietary transdermal delivery technology TPM®, against a leading commercial tretinoin formulation.

A total of 54 patients have been recruited for the randomised double blind study at three trial sites in Perth, Brisbane and Hamilton, New Zealand.

Phosphagenics anticipates the trial will be completed at the end of this quarter, with results to be announced Q3 2014.

The company said previous studies it has conducted demonstrated an increase in the delivery of trentinoin into the skin compared to a leading commercially available product as well as substantially deeper penetration of the drug.

This was achieved with less irritation to the skin and surrounding application area when evaluated against the comparator.

Tretinoin is a drug most commonly prescribed by dermatologists for topical treatment of acne, however, it causes adverse skin irritation in many patients and consequently leads to a large number of those patients withdrawing from treatment.

Phosphagenics explained that as a result, products often contain a less than optimal amount of tretinoin to reduce irritation but this leads to a decrease in efficacy as well.

“Dermatological products and particularly those with active ingredients that need to penetrate deeply into the skin but cause irritation, lend themselves perfectly to this technology,” Phosphagenics Limited CEO Harry Rosen said in the company’s announcement to the Australian Securities Exchange.

“They are therefore of great interest to our company.”

Email: info@phosphagenics.com

Website: www.phosphagenics.com

RHS completes ASX listing and progresses European patent application

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THE ROADHOUSE PHARMACY: Australian IVF-focussed company Reproductive Health Science (ASX: RHS) has completed its listing on the Australian Securities Exchange following a capital raising and a reverse takeover of AO Energy Ltd.

RHS wasted no time in announcing the European Patent Office (EPO) has issued a Notice of Intention to Grant the company’s microarray genetic testing under Comparative Genomic Hybridization (Patent no. 04 725 230.9).

The company explained that following the granting of this patent, it will hold patents across Europe, Australia, USA, China and New Zealand.

RHS’ lead product is ‘embryo select’ which is to be launched in mid-2014 as a two component system.

RHS claims embryo select has an immediate application to improve the success rate of In-Vitro Fertilisation (IVF).

The company explained 10 years of research and development has led to the development of a test to assess embryos for chromosomal abnormalities prior to implantation as part of an IVF cycle.

“We are delighted to have received the Notice of Intention to Grant from the European Patent Office, particularly given it is one of the first cases to be examined following recent revisions of procedures relating to the patenting of diagnostic technologies for genetic testing of embryos,” RHS Managing Director and CEO Dr Michelle Fraser said in the company’s announcement to the ASX.

“We have been responsible for the prosecution of this patent family since 2007 and we are pleased to have achieved such a milestone following our successful listing on the ASX.”

Having finalised its listing on the ASX, the company indicated its focus is now on the commercial roll out of ‘embryo select’, which it said is aimed at improving the outcome for IVF participants.

The launch of the kits for the lead product requires no further trials or research.

“We are highly encouraged by the strong support received during our transition onto the ASX with a substantially oversubscribed capital raising,” Dr Fraser said.

“We look forward to now concentrating on delivering on our key lead product ‘embryo select’ and anticipate first sales during the third quarter of 2014.”

Website: www.rhsc.com.au

Mithril Resources identifies new gossan at Nanadie Well

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THE DRILL SERGEANT: Mithril Resources (ASX: MTH) has claimed to have identified a 300 metre long zone of sub-cropping nickel gossan and copper mineralisation at the company’s Nanadie Well project southeast of Meekatharra in Western Australia.

 

Meekatharra project area showing location of Nanadie Well project. Source: Company announcement

The nickel-copper zone remains open along strike, however due to its sub-cropping nature and sand cover, the true width of the zone is unknown at this stage.

Mithril indicated the gossan is characterised by high values of nickel (up to 0.44 per cent), copper (up to 8.86 per cent) and platinum group elements (PGE’s) up to 557ppb platinum and palladium.

The nickel–copper zone lies 1.2 kilometres south east of Mithril’s Nanadie Well copper deposit (2004 JORC Code-compliant Inferred Resource of 36.07 million tonnes at 0.42 per cent copper – 151,000 tonnes copper / 74,000 ounces gold) and one kilometre south along strike from a strong geophysical (IP chargeability) anomaly which has not been previously drill tested.

Mithril stressed the nickel–copper zone remains untested by electrical geophysics (such as EM and IP) and drilling, although a ground EM survey completed by a previous explorer stopped west and south of the zone, and 2 holes drilled under the central portion of the zone failed to reach target depth.

The company said ground EM surveying will be undertaken as a priority in order to define potential drill targets along the zone.

“The nickel prospectivity of the Nanadie Well project area is further reinforced by recent petrological analysis of selected RC drill samples from the Nanadie Well copper deposit, which confirms the presence of weathered nickel sulphide minerals (violarite replacing pentlandite) associated with the copper minerals (chalcopyrite) throughout the deposit,” Mithril Resources said in its ASX announcement.

“This suggests that there is a magmatic nickel–copper sulphide component to the deposit’s mineralisation.

“The Nanadie Well project is emerging as a regionally significant exploration play, with Mithril holding over 40 strike kilometres of copper–nickel prospective Archaen greenstone stratigraphy within the project’s boundaries.”

The company explained this particular nickel gossan is the fourth priority target it has developed at Nanadie Well since it entered into a Farmin and Joint Venture agreement with the project’s owners Intermin Resources Limited (ASX: IRC) in December 2013.

Email: admin@mithrilresources.com.au

Website: www.mithrilresources.com.au

Trafford Resources encouraged by Zealous tin results

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THE DRILL SERGEANT: Trafford Resources (ASX: TRF) has received the final results of a recently completed drill program at the company’s 100 per cent-owned, Zealous tin discovery, within the Wilcherry Hill project in  South Australia.

 

Zealous tin prospect location, Wilcherry Hill, South Australia. Source: Company announcement

 

The drilling consisted of nine reverse circulation (RC) holes and one diamond hole.

Trafford explained the results replace the preliminary results from three metre composite samples it reported earlier this year with each three metre composite being split into individual one metre samples for more specific analysis.

The results returned consistent high-grade intercepts including:

12.3 metres at 1.1 per cent tin in 13ZLDH001 from 119 metres, including 2 metres at 1.97 per cent tine from 125 metres and 1.3 metres at 4.81 per cent tin from 130 metres;

10m at 0.78 per cent tin in 14ZLRC004 from 130m, including 4m at 1.33 per cent tin from 131m;

2m at 1.12 per cent tin in 14ZLRC005 from 44m;

2m at 1.17 per cent tin in 14ZLRC008 from 44m; and

1m at 1.34 per cent tin in 14ZLRC009 from 121m.

Broad, near surface zones identified included:

47m at 0.32 per cent tin from 31m in 14ZLRC005, including 7m at 0.47 per cent tin from 31m and 7m at 0.66 per cent tin from 42m; and

20m at 0.25 per cent tin from 43m in 14ZLRC008, including 4m at 0.74 per cent tin from 31m.

“Drilling continues to produce intersections of potentially economic tin grades suitable for both open cut and underground extraction,” Trafford Resources said in its ASX announcement.

“It has defined a strike length of over 300 metres to a minimum vertical depth of approximately 130 metres.

“The extent of the body remains open in all directions.

“Preliminary wireframe modelling of the tin mineralisation at Zealous demonstrates the potential robustness of the mineralisation – which is highlighted by the fact that eight of the seventeen holes drilled to date have intersected high grade (greater than 1 per cent) tin.”

According to Trafford the drilling at Zealous has produced an impressive total of forty four plus-0.5 per cent tin intercepts and twenty six plus-one per cent tin intercepts in eight holes.

In addition to the high-grade intercepts, seven holes have identified broad, continuous intersections with widths greater than 10m above a cut off of 0.1 per cent tin.

Website: www.traffordresources.com

PharmAust gets approval for PPL-1 Study in Man

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THE ROADHOUSE PHARMACY: PharmAust Limited (ASX: PAA) has received approval from the Research Ethics Committee of the Royal Adelaide Hospital to begin evaluation of proprietary drug PPL-1 in a Phase I/II clinical trial.

The clinical trial will be undertaken by the Royal Adelaide Hospital in approximately 12 to 15 human patients suffering from a variety of late stage cancers, potentially including the major cancers such as lung, pancreas, oesophageal, gastric, colorectal, ovarian, breast, prostate, liver, sarcoma, lymphoma, and melanoma.

In addition to measuring safety and pharmacokinetics of PPL-1, PharmAust said the trial will determine changes in various cancer markers.

Furthermore, the patient tumours will be biopsied where possible and also studied with the aid of a CT-PET scanner.

The company said the evaluation of PPL-1 is being undertaken in late stage cancer patients under the supervision of Professor Michael Brown (Principal Investigator).

All patients recruited in the trial will have failed ‘Standard of Care’ and will have been without treatment for at least two weeks.

The study will look at increasing doses of PPL-1 in cohorts of patients with each dose being administered daily for a period of 28 days.

The recruitment of patients by the Royal Adelaide Hospital will begin as soon as Site Specific Assessments have been undertaken and Governance Approval received.

“This is a ‘First in Man’ study and we are excited about the prospects of evaluating PPL-1 in cancer patients,” PharmAust executive chairman Dr Roger Aston said in the company’s announcement to the Australian Securities Exchange.

“As a ‘First in Man’ rising dose pharmacokinetic evaluation, our priority is to show safety.

“We are grateful and acknowledge NewSouth Innovations in this discovery and their continued support of the work emanating from the St George Hospital.

“The trial is the culmination of many years of research and development in the laboratory of Professor David Morris.”

Website: www.pharmaust.com

SomnoMed hits 28 per cent volume growth in Q3

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THE ROADHOUSE PHARMACY: SomnoMed Limited (ASX: SOM) announced it has increased sales volume by 28.3 per cent in Q3, compared to the same quarter in the previous year.

SomnoMed provides diagnostic and treatment solutions for Sleep-related Breathing Disorders including obstructive sleep apnea, snoring and bruxism.

The company’s total for units sold for the three months to the end of March 2014 were 11,010.

After growth of 13.1 per cent in Q1 and 23.6 per cent in Q2, the company said the growth of 28.3 per cent achieved in Q3 confirms the trend of SomnoMed’s accelerating sales volumes achieved in its global operation.

Total units sold for the nine months were 31,465 units, with growth of 21.8 per cent over the same period in the previous year.

Total revenues generated during the third quarter amounted to $6.5 million and 50 per cent more than in the previous year (30 per cent on constant exchange rates), bringing the year to date revenues to a total of $19 million and is 43 per cent up on last year.

“This is the highest volume growth achieved in a March quarter for the last three years,” SomnoMed executive chairman Dr Peter Neustadt said in the company’s announcement to the Australian Securities Exchange.

“We were able to see significant improvements in our US sales.

“Whilst the year on year growth in Q1 was only 2.8 per cent, Q2 growth improved to 10.1 per cent, whereas Q3 has now produced a growth of 22.8 per cent. Volume achieved in the March quarter in the US has set a new sales record.”

Neustadt identified a number of programs in the dental and medical markets in the US, which were initiated during 2013 as factors contributing to the results.

Another was the launch of the company’s SomnnoDent® Herbst, which he said has been successful and is likely to continue to show growing acceptance.

“Europe continues to generate strong growth in all the four European regions in which we are directly distributing our SomnoDent® products,” Neustadt continued.

“Pleasing results were achieved in APAC, where growth in Q3 came in at 17.3 per cent, the highest growth achieved for several years.

“This is due to marketing initiatives in Australia and New Zealand, good growth in Japan and the results of our Korean operation, which is now under our own control.”

Website: www.somnomed.com.au

What the Brokers Say

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WHAT THE BROKERS SAY: Interesting news and views from across the Resource Analyst universe.

www.beerandco.com.au

Metals of Africa (ASX: MTA)

Metals of Africa’s main project, Rio Mazoe in Mozambique, reported an average of 47.6 per cent lead, over 55 select samples from rock chips and trenching, with a maximum of 9.5 per cent copper at Rulio.

Rio Mazoe’s Meque prospect has artisanal lead-zinc-copper workings along 2.5 kilometres of outcropping mineralisation.

MTA’s Mkindu prospect, in Tanzania, has defined conceptual Olympic Dam IOCG style drill targets.

Broken Hill Type fertile geological setting dentified by BHP in 2001‐2003

In 2001, BHP began a program to identify Broken Hill Type prospective areas in Africa, focussing on tectonically and geologically favourable areas, along the northern margin of the Zimbabwe Craton, and to the south of the Congo Craton.

Despite promising results, BHP abandoned the program in 2003 for global corporate reasons at that time.

Rio Mazoe identified, in Tete province, north‐west Mozambique

Rio Mazoe covers about 857 square kilometres in north‐west Mozambique. MTA has three main prospects in the Rio Mazoe area:

Meque has 2.5km of outcropping mineralisation which has been mined historically for lead-zinc-copper-silver ores. Most of the adits have collapsed but there are shafts still in place to 35m in depth;

Ruilo has yielded many high grade galena samples, to 79.9 per cent lead, plus zinc-silver; and

Cocdeza has yielded high grade copper samples, with visible malachite, chalcocite and bornite.

MTA is farming into the Changara project, covering 511sqkm, which is co‐located with Rio Mazoe, and has five identified lead-zinc and copper-lead-zinc prospects.

Tanzania: Mkindu IOCG and Tanga gold/copper-gold

Mkindu is interpreted, from detailed areo‐magnetics and mapping, to have conceptual Olympic Dam IOCG style targets that need to be drill tested.

At Tanga, soil sampling has determined a zone of anomalous copper-gold, over more than 5km, with values up to 3 grams per tonne gold and 0.67 per cent copper.

Gabon: 90 per cent of 6,886sqkm with many lead-zinc-silver-copper occurrences

MTA has just acquired a large area in Gabon which has shallow drill defined lead-zinc-silver mineralisation over several kilometres.

Beer & Co conclusions

MTA is stalking elephants in elephant country. It has already found many high grade indications of potential projects.

www.breakawayresearch.com

Potash West (ASX: PWN)

Potash West continues to advance its 100 per cent-owned Dinner Hill SSP project, which forms part of the overall Dandaragan Trough project in Western Australia targeting greensands.

A scoping study has shown the feasibility of a 20 year, plus-340,000 tonnes per annum SSP production facility, supplying both domestic and Asian markets, based on forecast USD cfr SSP prices of A$383/tonne.

The keys to the project are a low ($144 million) start-up capital, and relatively low operating costs due to the flat-lying, shallow simple mineralisation that is amenable to standard treatment options, and short transport distances.

The company is assessing further process improvements aimed at improving the project economics.

The location is close to a potential market in Asia, with demand for fertilisers expected to continue to grow with the need to continually increase crop yields to feed a growing population.

The Dandaragan Trough project has returned a positive scoping study on a low start-up capital single superphosphate producing operation.

Results indicate an NPV of $218 million and an IRR of 26 per cent, with scope for improvement.

The project area has excellent access to infrastructure, and is close to export ports and growing markets.

Dinner Hill phosphate Indicated resource of 90 million tonnes at 2.65 per cent phosphate, 3.6 per cent potassium and 4.5 per cent calcium.

The deposit remains open to the north and east, and with considerable exploration potential.

Potash West holds 100 per cent of the Dandaragan Trough project covering extensive greensand deposits that can be processed to produce a range of fertiliser and chemical products.

Since listing in May 2011 considerable progress has been made, including the definition of indicated resources and scoping various development options.

The initial scoping study assessed the viability of treating the glauconite sands to produce a series of products using the company developed “K-Max” pyro/hydrometallurgical process.

This developed positive outcomes at the then economic conditions, albeit with high capital costs that would require a major partner.

This option is being kept on the backburner, however can be reactivated should conditions allow.

Disclaimer: The above is intended as a guide only. The Roadhouse accepts no responsibility for investments made from this advice, successful or otherwise.

The views, opinions or recommendations of this article do not in any way reflect the views, opinions, recommendations, of The Resources Roadhouse.

The Roadhouse makes no representation or warranty with respect to the accuracy, completeness or currency of the content. The content is for educational purposes only and does not constitute financial advice. Independent advice should be obtained from an Australian financial services licensee before making investment decisions.

Raising funds across the Boards

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THE FUND RAISER: The trend of small raisings continued as the juniors boosted their bank balances this week.

Keysbrook mineral sands project fully funded

MZI Resources (ASX: MZI) has secured approximately US$64 million in Project Debt Facilities for its development ready Keysbrook mineral sands project in Western Australia, paving the way for construction to commence in late June 2014, with first production scheduled for mid-2015.

The debt funding offer is fully underwritten by RMB Australia Holdings Limited (RMB) and has been arranged by RMB Resources Limited.

The Project Debt Facilities, combined with a previously announced US$41.5 million Keysbrook funding package to be provided by Resource Capital Fund VI L.P. (RCF), mean MZI is now fully-funded for the construction and development of Keysbrook.

“In our view, having two highly regarded financial institutions express their confidence in Keysbrook through the provision of funding is a sign of the project’s technical and economic strength,” MZI chief executive Trevor Matthews said.

“Our feasibility studies show that Keysbrook will generate strong returns, even at this relatively low point in the mineral sands economic cycle.

“Based on forecasts provided by mineral sands analysts, the recovery in the feedstock demand cycle should be well underway by the time Keysbrook comes into production, leaving MZI ideally placed to benefit from the project’s relatively low capital and operating costs, premium product suite and access to key markets.”

Sale of Californian Assets

Neon Energy (ASX: NEN) has executed a binding Purchase & Sale Agreement with a major Californian exploration and production company, for the sale of the company’s Californian assets with a purchase price of US$26.95 million.

The buyer is a subsidiary of a publicly listed company, which Neon said wishes to remain anonymous for commercial reasons.

The deal comes as a result of Neon Energy having appointed Roth Capital Partners last year to consider various initiatives to realise additional value from the company’s Californian asset portfolio.

The review determined the capital investment required to achieve a material return on investment from those assets would be be better off being spent on capturing high potential exploration assets elsewhere in the world.

With cost reductions Neon has recently implemented, the divestment of the Californian assets will achieve a reduction in group corporate overheads of some 40 per cent.

Neon Energy said this means it will be well funded to embark on a new phase of growth, and does not expect to raise further funds in the foreseeable future.


Placement for WA gold and copper exploration

Aruma Resources (ASX: AAJ) has agreed to raise $560,000 through a placement of 20 million shares at a price of 2.8 cents per share.
 
The placement is being made to professional and sophisticated investors with Grange Capital Partners acting as Lead Manager to the offer.

The funds raised will be used for targeted exploration programs on the company’s Glandore gold project and Bulloo Downs copper project as well as costs of the issue and general working capital.

Completion of $20.4 million placement

Maverick Drilling and Exploration (ASX: MAD) has completed a $20.4 million placement to institutional and sophisticated investors at 31 cents per share.
 
The Placement closed oversubscribed with strong support from both existing and new investors.

The proceeds of the placement will be used principally to fund the human resource talent and infrastructure required by Maverick to enhance the company’s oil and gas technical capability and better position it to assess, develop and execute future oil and gas opportunities.

“We appreciate the support of Shareholders for this important addition to our balance sheet,” Maverick Drilling and Exploration Chief Executive Officer and Executive Chairman J. Michael Yeager said.

“Our rebuilding of Maverick into a fully capable Oil and Gas company and the pursuit of new opportunities is in progress as discussed this week.

“We look forward to updating shareholders as we reach key milestones in this important refocus of the company.”

This Week in The Roadhouse Pharmacy

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THE ROADHOUSE PHARMACY: There’s a great deal of interest in the Bio-tech sector at the moment, so we have opened our own Pharmacy to keep our readers up to speed.

SomnoMed hits 28 per cent volume growth in Q3

SomnoMed Limited (ASX: SOM) announced it has increased sales volume by 28.3 per cent in Q3, compared to the same quarter in the previous year. READ MORE…

New version ReCell launched in UK and Europe

Regenerative medicine company Avita Medical (ASX: AVH) has developed and released to market a new version of ReCell® ‘Spray‐on Skin®’ that no longer requires refrigeration. READ MORE…

Starpharma expands drug delivery program with AstraZeneca

Starpharma Holdings (ASX: SPL) has signed a second, expanded agreement with AstraZeneca in the field of cancer medicine using Starpharma’s proprietary DEP™ dendrimer drug delivery technology. READ MORE…

US Patent allowance extends strong IP position

Antisense Therapeutics (ASX: ANP) has been informed the US Patent Office has allowed US Patent 61/132973 entitled ‘Methods for treating multiple sclerosis (MS) using antisense oligonucleotides’. READ MORE…

US Patent allowance extends strong IP position

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THE ROADHOUSE PHARMACY: Antisense Therapeutics (ASX: ANP) has been informed the US Patent Office has allowed US Patent 61/132973 entitled ‘Methods for treating multiple sclerosis (MS) using antisense oligonucleotides’.

Antisense said this covers the use of the ATL1102 compound to reduce brain lesions in relapsing-remitting multiple sclerosis (RRMS), and progressive forms of MS including secondary progressive MS (SPMS) and primary progressive MS (PPMS) and at the desired doses, until 23 June 2029, with potential for an extension of up to five years.

The company said the new US patent forms part of its portfolio of intellectual property protecting ATL1102 and its uses in MS and includes a granted United States patent US 8,415,314, Australian Patent 2009271678 and corresponding applications in Europe, Japan and Canada, covering the use of ATL1102 in the treatment of the most common form of the disease, RRMS.

This new US patent adds important commercial value to ATL1102 and further supports the company’s partnering plans with a recent publication showing that reduction in brain lesions with Tysabri® a monoclonal antibody drug to the VLA-4 receptor (same target as ATL1102), can benefit patients with progressive forms of MS.

There is only one approved compound in the US, Novantrone®, for use in secondary (chronic) progressive MS which can only be used for two to three years because of safety limitations.

The patent also claims all desired doses of ATL1102 for use in these treatments including those described in the pharmacometric modelling for dosing in the next clinical trial being a six month Phase IIb study.

The modelling recommended doses that on a cumulative basis are equivalent to those tested in the recent toxicology study.

The granting of the patent follows a previous announcement by Antisense in regards to major findings from an ATL1102 chronic monkey study and plans to meet with the FDA in Q3’2014 at a proposed pre-Investigational New Drug meeting regarding the study design for a Phase IIb MS trial.

The company said it expects these interactions with the FDA to run in parallel to those with potential pharmaceutical partners.

“We estimate that over $30 million has been spent on the development work undertaken to date by the company and its previous commercialisation partner in progressing ATL1102 in the MS indication towards moving the compound into a Phase IIb trial,” Antisense Therapeutics CEO and managing director Mark Diamond said in the company’s announcement to the Australian Securities Exchange.

“We are delighted that the recent findings from the toxicology study provide the opportunity for us to capitalise on this investment and this together with our US patents will underpin our partnering and commercialisation plans.”

Website: www.antisense.com.au