TORONTO, ONTARIO--(Marketwired - Jun 6, 2013) - Biologix Hair Inc. (BLGX)(BLGX) has released a detailed report on the progress of Beijing Institute of Technology toward refining and standardizing Biologix Revive, the basis of the Biologix Hair Therapy System™.
Biologix Hair Science Ltd.™, the wholly owned subsidiary of Biologix Hair Inc. that owns the worldwide intellectual property rights to the Biologix Hair Therapy System™, intends to conduct formal clinical trials and complete other related procedures in order to obtain FDA approval for a standardized "single and shelf-life-stable" formulation of Biologix Revive. In preparation, Biologix Hair Science Ltd.™ contracted in mid-2012 with Beijing Institute of Technology (BIT) (Beijing BIT&GY Pharmaceutical R&D Co. Ltd.) to refine and standardize the Biologix Revive formulation. During the period July 2012 through April 2013 BIT has completed four extensive and significant steps in this process, as follows.
Experiment preparation (July 2012 ‐ December 2012): BIT organised an experienced team of research specialists in order to define the technology needed to perform the work and to design the experiments based on the composition of the formula and the final goal of having the formula in one, possibly two vials. The technology selected to perform these tasks comprises the best available in pharmaceutical laboratories to date and includes the following:
High-performance/pressure liquid chromatography (HPLC) is a chromatographic technique used to separate a mixture of compounds in analytical chemistry and biochemistry with the purpose of identifying, quantifying or purifying the individual components of the mixture. Chromatography identifies components and/or molecules by exposing them to different light wavelengths and, based on the wavelength of the reflected light from each specific molecule, then identifies exactly what molecule is being worked on. This allows the BIT team to identify, separate and study molecules and their interaction with a high degree of precision.
Liquid chromatography-mass spectrometry (LC-MS) is a chemistry technique that combines the physical separation capabilities of liquid chromatography with the mass analysis capabilities of mass spectrometry. LC-MS is a powerful technique used for many applications, which has very high sensitivity (meaning it can work with very small amounts of the molecules being studied) and selectivity (to identify individual molecules that are very like one another). This allows for detection and potential identification of chemicals in the presence of other chemicals in a complex mixture. This is the case with the Biologix Revive formula, which has 24 different molecules working in unison to restart hair growth in dormant hair follicles.
Gas chromatography-mass spectrometry (GC-MS) is a laboratory method that combines the features of gas-liquid chromatography and mass spectrometry to identify different substances within a test sample. GC-MS can identify trace elements in materials that were previously thought to have disintegrated beyond identification. GC-MS is used to perform a specific test, which positively identifies the actual presence of a particular substance in a given sample (whereas a non-specific test merely indicates that a substance falls into a category of substances).
Inductively coupled plasma atomic emission spectroscopy (ICP-AES) is an analytical laboratory technique used for the detection of trace metals and minerals, like those among the 18 minerals in Biologix Revive. This form of emission spectroscopy uses inductively coupled plasma to produce excited atoms and ions that emit electromagnetic radiation at wavelengths characteristic of a particular element. The emission intensity is indicative of the concentration of the element within the sample.
Atomic absorption spectroscopy (AAS) is another laboratory procedure designed for the quantitative determination of chemical elements employing the absorption of optical radiation (light) by free atoms in the gaseous state. This technique is used to determine the concentration of a particular element in a sample to be analyzed, a test that is particularly important in the study of the minerals mixture.
Additionally, the laboratory at BIT is also utilizing the following equipment for their tests and analyses:
Moore concentration analyzer
Insoluble particles analyzer
Polarimeter, among others
BIT has also acquired all of the chemical reagents that are used to help in the analysis of each of the APIs (Active Pharmaceutical Ingredients) and their respective interactions.
Finally, a series of simulations were run with some of the equipment in order to prepare for the arrival of the APIs and the Reference Standards. Acquisition of the APIs and the Reference Standards is another important investment Biologix has made. The APIs are each of the 24 molecules present in the formula and the Reference Standards are samples of those molecules sold by certified providers which serve as comparison references to compare the actual APIs currently in use to ideal samples of those same molecules.
Preliminary tests (December 2012 - March 2013): After receiving the Reference Standards, the team carried out about 50 preliminary tests, including character, infrared absorption, ultraviolet absorption, pH, osmotic pressure Moore concentration, related substances, assay, etc. and acquired more than 300 basic pieces of data and more than 100 experimental parameters were identified during this phase.
API inspection (February 2013 - April 2013): Since acquisition of APIs, the team has carried out successively more than 100 tests similar to those carried out with the reference standards. However, in addition to the ones mentioned before, particle identification, visible particles measurements, particulate matter determination, heavy metals concentration analysis and related substances analysis have been made. Each of the test items of APIs took four samples, and each of samples was detected 1-5 times. So far, the team has acquired more than 1000 pieces of original data.
Stability of API under high temperature and high light, Biologix Revive formula composition test 1 (March 2013 - April 2013): In this stage the stability of eight kinds of APIs was evaluated under conditions of high temperature and intense light and the main influencing factor in their transformation has been determined. The stability was tested at 0, 5 and 10 days after high temperature and intense light treatment. The parameters analyzed are the ones described previously, and each of the test items required two samples. Each of the samples was detected between one and five times, depending on the API and the results obtained during the initial tests. This degree of repetition and precision greatly increases the likelihood of success. In this phase, more than 600 pieces of original data have been added to the vast amount of data already collected. According to stability data of APIs under high temperature and high light conditions, it is possible to predict the stability of each component after being mixed and accordingly design a formula with the best possible packaging and storage conditions.
Dr. Diego Castresana, Vice President of Research and Development for Biologix Hair Science Ltd.™, summarized: "The significance of the work this BIT team is doing to develop a stable, standardized formulation of Biologix Revive cannot be overstated. It is a critical step on the path to application for FDA approval of the Biologix Hair Therapy System™.
"This progress report from BIT summarizes what I have observed over the last 10 months while receiving frequent updates from the team: Only the highest professional standards have been implemented and requisite attention has been focused on methodology, equipment, materials, method and processes throughout. I am confident BIT will produce a refined, standardized and fully tested formulation of Biologix Revive, with preliminary results expected by the end of this year and the final result by the end of the first quarter 2014, that will allow Biologix Hair Inc. to successfully navigate the application process for approval from FDA, Health Canada, the European Medicines Agency, etc."
About Biologix Hair Inc. and Biologix Hair Science Ltd.
Biologix Hair Inc. (Biologix Hair), together with its wholly owned biotechnology subsidiary, Biologix Hair Science Ltd. ™ (BHS), is focused on realizing the full market potential for its patent-pending hair loss prevention and regeneration treatment - the Biologix Hair Therapy System™ - and its demonstrated ability to prevent and reverse the effects of alopecia, which plagues hundreds of millions worldwide.
Between mid-2004 and mid-2012, more than 30,000 pre-clinical-trial treatments of Biologix Revive - the essence of the Biologix Hair Therapy System™ - were administered to 5,000-plus patients in South America suffering with varying degrees of alopecia, as well as people seeking preventive treatment. The participating treatment clinicians subjectively observed and reported that virtually 100% of preventive care clients continued to retain their healthy hair and an estimated 80-85% of the males and 90-plus% of the females treated for hair regeneration experienced significant regrowth of their own natural hair. And among alopecia areata patients, virtually total hair regrowth was observed in 100% of the cases. To date, no negative side effects have been reported.
BHS is currently focused on obtaining FDA approval for its breakthrough hair loss prevention and regeneration therapy and has initiated a research and development program with one of the world's leading medical research universities, the Beijing Institute of Technology (BIT). The R&D program, expected to take approximately twelve months to complete, is an important final step before formal clinical trials and the FDA approval process begins.
Additionally, on May 11, 2012, Venable LLP, the Washington-based law firm overseeing the worldwide IP and regulatory approval processes on behalf of BHS, filed a Patent Cooperation Treaty (PCT) application on behalf of BHS for Biologix Revive in Geneva, Switzerland. The PCT is an international treaty, administered by the World Intellectual Property Organization (WIPO), to which 147 countries have as of now contracted, including Canada and the United States.
Biologix management is determined to be in a ready position to capitalize on the high-margin sales potential of the Biologix Hair Therapy System™, if and when FDA and other major market approvals are forthcoming.
As BHS advances the regulatory approval process, Biologix Hair, together with wholly owned subsidiary companies operated by BHS, are rapidly developing a global distribution network of licensed clinicians and medical practitioners seeking to become Certified Biologix Hair Therapists™ and secure exclusive territorial purchasing and treatment rights for the Biologix Hair Therapy System™.
Biologix Hair has decided not to risk creating any potential regulatory conflicts by offering treatment outside the United States and other major high-product-margin markets until FDA approval has been granted. Therefore, the Biologix Hair Therapy System™ is not yet available other than to the 5,000+ patients who participated in the pre-clinical-trials conducted in South America.
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This announcement is not an offer to sell any Biologix Hair Inc. ("Biologix") securities. Offers for any given security are made only through applicable offering circulars and related documents filed with the SEC pursuant to the Securities Act of 1933 or the Securities Exchange Act of 1934. Certain statements contained herein and subsequent oral statements made by and on behalf of Biologix may contain "forward-looking statements". Such forward-looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and includes, without limitation, the development of treatment centers and approval from regulatory authorities as well as the ability for Biologix to obtain adequate financing to meet its business objectives. Forward-looking statements express our expectations or predictions of future events or results. They are not guarantees and are subject to many risks and uncertainties. There are a number of factors beyond our control that could cause actual events or results to be significantly different from those described in the forward-looking statements. Any or all of our forward-looking statements in this report or in any other public statements we make may turn out to be wrong. We undertake no obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise. In Canada, Europe and the United States, the Biologix treatment is not approved for use by Health Canada, EMA or the FDA. The company makes no representations that it will receive Health Canada, EMA or FDA approvals.