"The stage is set..." - Dr Tarl Prow - September 2012
Personally, I'm not concerned about who or when the first product will be commercialised... I'm far more interested in our first license agreement, and in my view that's not too far away...
When the single most important piece of news to arrive during this reporting period, something which remains of significant value to the company and even more so to its partners, fails to receive one single mention in the Annual Report, I'm not sure about others here, but I interpret this kind of obvious omission to indicate the arrival of something extremely promising in the very short term...;)
Additionally, I continue to enjoy these conservative distracting expressions... "OBJ has recently recruited an experienced project manager who will be tasked with undertaking the product and distribution development that 'may' lead to commercialisation of OBJ's first product application"
So, our new Project Manager "will" be tasked with undertaking product distribution for something which "may" lead to commercialisation?
When this new position was advertised it stated, "experienced and motivated Market Development Manager to lead the final development stages and manage the international roll-out of a unique platform of sports and consumer pain and injury management products" so I'm not sure Glyn would've said to this new employee, ah yeah look we 'may' not be needing you, but then again we potentially may, so just relax and make yourself feel right at home - sorry about all those boxes stacked up in your office but if you can squeeze yourself in there and be resourceful if you need to find a seat - Any box labelled with, 'Savantac' is fine, but just steer clear of anything marked with, 'Millipore'... dried cows blood... don't ask - something to do with R&D for diabetes diagnostic tests, I think...?
FY2012 under review - The speculative version ;)
A couple of warmers...
(By utilising physical science rather than chemistry, OBJ is able to provide its international partners with cost-effective means of enhancing the performance of a wide range of therapeutic, applications, often to levels not possible using costly formulation chemistry.)
(The announcement of the Joint Development Agreement with Procter and Gamble (P&G), the world’s largest consumer goods company and the expansion of programs with GlaxoSmithKline (GSK), one of the world’s largest pharmaceutical companies were major accomplishments for the period.)
It should be noted that if the expansion of programs with GSK was indeed a major accomplishment during this reporting period, then it has certainly been played down. Silence 'may' indeed be golden.
Procter and Gamble (The Company has been working with a number of the teams at P&G’s Cincinnati facility for some time culminating in a funded multi-product development collaboration with the clear objective of taking OBJ’s technologies to market (in P&G products) provided a number of evaluations met P&G’s expectations.)
met: past and past participle of meet... provided a number of evaluations 'meet' P&G's expectations, or have they already been 'met'?
GlaxoSmithKline (OBJ has been working with GSK’s Consumer Product Groups in the UK for many years and the relationship between the two companies was further expanded during the period with the inclusion of a new pharmaceutical development program with GlaxoSmithKline’s USA based pharmaceutical group. A funded study program is currently under negotiation.)
(During the period, an expansion to the GSK (UK) Oral health program was also initiated. The shareholder update of March 2012, reported continuing successes in the enhanced delivery of actives ingredients used in toothpaste for the prevention of Caries (tooth decay). This work was later extended to include sensitive teeth (hypersensitivity) and tooth harnessing (remineralisation).
Clinical trials for tooth hypersensitivity and remineralisation with the new NUPRO Sensodyne Prophylaxis Paste With NovaMin was completed last month and last updated on August 16, 2012, although no results from these trials have been released as yet.
Links for Clinical Trials & FDA pre-market application
Cosmetic Collaborations (Cosmetics and Skin care remain a key focus area for the Company and a number of new collaborations were formed during the period. Several existing collaborations were expanded and new laboratory techniques and processes developed to provide the Company with ever increasing expertise in skin penetration. The Company’s powered technology, known as eSkin, was expanded to include web based personalised skin care capabilities which have been enthusiastically received by our partners and negotiations are ongoing with one potential partner.)
Jasetheace raised a valid point recently in regards to potential licensing negotiations for the eSkin device, which could be awaiting Dermaportation patent allowance from the EPO. This in my view may also explain why we haven't received further details in regards to P&G securing Access Rights for Beauty Care. Whilst the JDA with P&G has already been executed, I imagine it would be difficult to license IP for protection of this technology in Europe when it hasn't been granted to its assignee/inventor yet.
Measured dose applicators (There is mounting international pressure in the pharmaceutical sector to control the dose of topical products, especially those containing non-steroid anti inflammatory compounds. As these drugs are a good target for our magnetic micro-array technologies, the Company moved to develop and file patents for a number of new enhanced delivery measured dose devices. Two such product groups are under development and the Company has received strong interests from its current partners.)
Unless some of these patent applications reported over recent times are being lodged as trade secrets, or held back from publication for a long period of time, I continue to wonder whether there exists another holding company additional to International Scientific Pty Limited?
Scientific and Laboratory Programs (led by Dr Matthew McIldowie)
(We have endeavored to enhance our core research capabilities through the refinement of fundamental skin analysis and analytical techniques that allow the OBJ team to engage a broader range of cosmetic and pharmaceutical actives provided by our partners. The OBJ laboratory team has expanded its in vivo assessment capabilities with the incorporation of cyanoacrylate biopsy/differential tape stripping methods. These in vivo methodologies in cooperation with OBJ’s extensive array of in vitro skills have already proven a success to projects such as for the P&G program.)
This allows us to speculate further with the information shared in Post: 8543569 relating to the North Carolina State University research team headed up by Joseph DeSimone and his University spin-out company, Liquidia Technologies from the RTP.
In that post I highlighted an article from the online site, Nanotoxicology which was published in March 2012 under the title of, Quantum dot penetration into viable human skin and authored by a number of regular OBJ collaborators, but importantly the authors also included, Dr Tarl Prow from the University of Queensland and Dr. Nancy A. Monteiro-Riviere from North Carolina State University.
I intentionally omitted the following abstract from that publication in my post as some here are quick in writing off the idea of OBJ's work involving a variety of different analytical techniques or technology integration with other delivery methods such as, Enhanced sonophoretic delivery (ultrasound), Enhanced iontophoresis or in this instance one of the more recently adopted analytical techniques known as "tape stripping"
Systematic studies probing the effects of nanoparticle surface modification and formulation pH are important in nanotoxicology and nanomedicine. In this study, we use laser-scanning fluorescence confocal microscopy to evaluate nanoparticle penetration in viable excised human skin that was intact or tape-stripped. Quantum dot (QD) fluorescent nanoparticles with three surface modifications: Polyethylene glycol (PEG), PEG-amine (PEG NH2) and PEG-carboxyl (PEG-COOH) were evaluated for human skin penetration from aqueous solutions at pH 7.0 and at pHs of solutions provided by the QD manufacturer: 8.3 (PEG, PEG-NH2) and 9.0 (PEG-COOH). There was some penetration into intact viable epidermis of skin for the PEG-QD at pH 8.3, but not at pH 7.0 nor for any other QD at the pHs used. Upon tape stripping 30 strips of stratum corneum, all QDs penetrated through the viable epidermis and into the upper dermis within 24 h.
Some may also remember this piece in relation to, The 2nd Annual International Nanodermatology Conference held during March of this year in California where six international experts in the field of dermatology and nanodermatology were invited to present to a large group of industry participants and policy makers. The event was sponsored by Merck, Schering-Plough, Johnson & Johnson, Horiba Scientific, P&G, and BASF.
Two of the six presenters included, Dr Tarl Prow from UQ, and Dr. Nancy Monteiro-Riviere from North Carolina State University:
Nanodermatology is a relatively new branch of engineering that is making rapid inroads in both the diagnosis and treatment of dermatologic disease. Nanotechnology applies the unique properties of matter on the nanoscale for the purposeful design of new materials. Among US patent holders in nanotechnology, the sixth largest is a cosmetics company, which comes as no surprise as this science can be used to enhance topical delivery of a broad range of consumer products. Concerns regarding incidental exposure to nanomaterials and the potential associated toxicity have generated considerable interest in determining the extent to which nanoparticles may penetrate skin as well as under what conditions - key properties for both efficacy and toxicity. Work by investigators to date highlight that the positive benefit of engineered nanoparticles for use in cosmetics and as tools for understanding skin biology and curing skin disease outweigh potential toxicity concerns.
At the second international conference of the Nanodermatology Society clinicians, scientists, members of industry, and policy makers gathered in San Diego, California on March 16th 2012 to review and discuss recent advances in nanotechnology and potential pitfalls as they pertain to dermatology. The conference was held at the Manchester Grand Hyatt in conjunction with the 70th Annual Meeting of the American Academy of Dermatology. The program included six presentations by leading experts in dermatology and nanodermatology, and covered a broad range of subjects including: updates in photoprotection, nano-needle drug delivery, cutaneous penetration of nanomaterials, nano-encapsulation of acne therapeutics, and siRNA conjugated nanoparticles for the treatment of skin disease
Dr. Nancy A. Monteiro-Riviere (North Carolina State University, NC)discussed skin penetration of nanomaterials, an important topic both for patients treated with nanomaterials as well as researchers handling them. Nanomaterials are readily taken up by keratinocytes through scavenger receptor and low density lipoprotein receptor related pathways. It is well established that nanoparticle size affects penetration. Using fluorescently labeled fullerenes, Dr. Monteiro-Riviere demonstrated that the coating, shape and delivery vehicle of a nanoparticle affects skin penetration, systemic absorption and immune activation. Her more recent investigation focuses on host factors that influence nanomaterial penetration. Both repetitive flexing and skin abrasion did increase penetration of fullerenes. The penetration of titanium dioxide (TiO2) and zinc oxide (ZnO) sunscreens was shown to be minimal on normal skin. Penetration of the TiO2 slightly increased following UVB induced sunburns, though no change was noted with the ZnO treated skin. Pretreatment of the skin with water and alcohols did not increase penetration, though this was send with cyclohexane pretreatment. Finally, Dr. Monteiro-Riviere shared some of the unforeseen hazards of nanomaterial research, including the discovery of formaldehyde in a stock nanoparticle she was using for a toxicity assay and the realization that the discordant results of a penetration study conducted in her lab and at the FDA's was due to the age of the pigs (and the older pigs larger follicular ostia). Dr. Tarl Prow (University of Queensland, Australia)discussed his work on tracking nanoparticles in human skin using non-invasive imaging, mainly focusing on the fluorescence lifetime imaging microscopy (FLIM). To date, there has been a lack of highly effective techniques to assess nanoparticle penetration and its biological effects in human studies. Dr. Prow reviewed his work with FLIM to simultaneously determine zinc oxide nanoparticles (ZnO-NP) penetration profiles and metabolic state (via NAD(P)H changes). His work enabled these determinations in nonlesional skin as well as in subjects with altered barrier function (including tape-stripped skin and in psoriasis or atopic dermatitis lesions) making it highly clinically relevant. It was found that there was increased ZnO-NP signal within the stratum corneum of disrupted and lesional skin, but the ZnO-NP did not penetrate into viable human epidermis in any of the studied groups. Dr. Prow also reported that there was no consistent ZnO induced NAD(P)H effects on lesional or non-lesional skin. He concluded that FLIM has the potential to non-invasively evaluate the potential exposure and metabolic consequences of nanoparticle-containing topical products in human subjects. - The Second Annual International Conference the Nanodermatology Society
Further to this association with the North Carolina State University, Dr Prow's most recently authored work is a solo piece titled, Multiphoton microscopy applications in nanodermatology which covers Multiphoton microscopy being used as a tool for tracking nanoparticles and assessing endogenous auto fluorescent molecules. Dr Prow appears quite excited about these news applications, and in closing he reports, "The stage is set for advanced, clinical imaging focused nanoparticle trials that can directly address critical issues in nanomedicine and nanotoxicology"
We can also click on the references tab to Dr Tarl Prow's paper and locate the name, DeSimone, JM - Strategies in the design of nanoparticles for therapeutic applications
For anyone who may have missed the TedMed presentation by Dr Joseph M DeSimone talking about his Liquidia Technologies proprietary particle engineering and manufacturing technology, here it is again. Liquidia Technologies and its collaborative development partners, GlaxoSmithKline and Procter & Gamble are interested in the physical properties of cells, and some media reports have claimed that the Liquidia/GSK deal could be worth up to $400m to Liquidia and is anticipated to revolutionize drug delivery around the world. But like all big things, mum's the word!
(In response to the growing commercial need for controlled dose/applicator packaging for various drugs, the OBJ laboratory team has developed and prototyped a low cost packaging solution based on deformable microchambers named the “Popper”. These micro-chambers can deliver precise volumes of drug while simultaneously acting as the product applicator. The clever design also allows for the incorporation of OBJ’s FIM technology.)
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OBJ patent abstract An apparatus for facilitating transdermal delivery of therapeutic substances, said apparatus comprising: an electromagnetic field generating device including asolid state switching devicecoupled to a coil which has electrical connectivity at both ends to allow unidirectional flow of current, thesolid state switching devicebeing operative to energize the coil with direct current to selectively produce an electromagnetic field; a control device coupled to thesolid state switching deviceto control said field generating device to alternately produce active and substantially inactive electromagnetic field portions by selectively energizing the coil, each said active electromagnetic field portion having a frequency of between 1 Hz and 100 Hz and comprising a plurality of generally rectangularly-shaped electromagnetic field pulses wherein each electromagnetic field pulse has a duration of between 25 .mu.s and 100 ms, each said substantially inactive electromagnetic field portion including no electromagnetic field pulses, wherein the duration of the inactive electromagnetic field portion is longer than the duration of the active electromagnetic field portion
In a highly specific form of the invention the device consists of a magnetic material prepared as a barium ferrite bi-phasic polymer,comprising parallel bands of magnetic material, separated by an insulating material, aligned in such a manner that each band is of opposite polarity.Desirably, the magnetic material the barium ferrite bands are constrained in a flexible polymer material of between 0.5 and 1.00 mm height, between 2.00 and 3.00 mm width andoriented in continuous strips having an insulator of 0.1 mm thickness separating each component. In this respect the top and bottom "films" are provided only to hold the materials in place.
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OBJ patent abstract Rotatingelectron orbitsof dissolved molecules rotating in a magnetic field, act to generate small but significant electrical fields of polarity specific to the orientation of the magnetic field. An applied temperature difference causescharged electronsin the therapeutic material, to travel from one magnetic polarity, which effectively charges the molecules. Charged molecules (for example conduction-band electrons) will move along temperature gradients due to static and the relationship between temperature and kinetic energy. When there is a magnetic field transverse to the temperature gradient and the carriers are electrically charged, they experience a force perpendicular to their direction of motion (also the direction of the temperature gradient) and to the magnetic field. This process effectively increases the beneficial repulsive force subjected on the molecules.
OBJ Price at posting:
1.4¢ Sentiment: LT Buy Disclosure: Held
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