Our History
ReGen Therapeutics Plc was formed in February 1998 to develop Colostrinin™, a proline-rich polypeptide complex derived from mammalian colostrum. The complex and the peptides within it are viewed as having potential utility in neurodegenerative illnesses such as Alzheimer’s disease, Parkinson’s Disease, Multiple Sclerosis and Amyotrophic Lateral Sclerosis.
The Company’s shares were admitted to trading on the London OFEX market in December 1998. ReGen floated on the Alternative Investment Market of the London Stock Exchange in March 2000, where the shares continue to be quoted and actively traded. This facility has continued to be the Company’s main source of funding. The Company has also maintained an American Depositary Receipt Program in the United States “Over-The-Counter” (OTC) financial sector to give it as wide financial appeal as possible.
Colostrinin™ was originally identified by scientists working in Poland, where early clinical studies, dating back to 1995, had indicated a significant potential benefit to Alzheimer’s disease sufferers. ReGen therefore conducted a placebo-controlled clinical trial of it’s own on Alzheimer’s sufferers in Poland, which completed in mid-2002. Results from the trial showed 33% of patients achieved stabilisation or improvement in their disease condition after 30 weeks of treatment, with efficacy demonstrated in both mild and moderate symptom groups. A good safety profile and no Serious Adverse Events or other safety concerns were observed. An article reviewing the results of this trial was published in the February 2004 issue of the Journal of Alzheimer’s Disease.
The natural origin and nature of Colostrinin™ means that it conforms to the general criteria for non-pharmaceutical health supplements. Thus, since 2003 ReGen has been developing a nutraceutical version of Colostrinin™. In July 2006, the Company announced it had signed its first deal to commercialise Colostrinin™ with Metagenics Inc., a leading developer, manufacturer and marketer of nutraceuticals based in San Clemente, California. Metagenics markets Colostrinin™ as a nutraceutical under the brand name CogniSure™ in North America. CogniSure™ has been on sale, via healthcare professionals in the North American market, since the last quarter of 2007. In July 2007, the licensing agreement with Metagenics was extended to also include Australasia, where the product is on sale through Metagenics’ subsidiary Health World Ltd.
In March 2008, the Company announced that it had signed the first European distribution agreement for Colostrinin™ with Golgi Pharmaceuticals Ltd of Cyprus. The product is approved for sale as a nutritional supplement through the professional and retail channels, which allows distribution in all health food stores and pharmacies. Cyprus is a member of the European Union which, with the US and Japan, is one of the three key target areas for Colostrinin™.
Since the beginning of 2008, additional agreements have been signed with distributors in Greece, Turkey, the Balkans, Poland and the United Kingdom. Also, in July 2010, ReGen announced it had signed a supply agreement with USV Limited, a leading Indian company based in Mumbai, providing entry into the second most heavily populated market in the world, which has significant potential for long term profitability. Discussions with potential licensing partners in other areas of the world are ongoing.
ReGen has also investigated the possibility for a nutraceutical targeted at domestic dogs and cats, and to this end conducted a study in 2007 at a UK-based veterinary practice. The results of the study showed that Colostrinin™ could significantly reduce the symptoms of cognitive dysfunction in aged cats and dogs. That Colostrinin™ was effective was reinforced by the fact that when animals were assessed one month after completion of the study, and having had no Colostrinin™ for one month, most animals showed a worsened condition.
ReGen believes that the results show a potential benefit for ageing cats and dogs and is seeking industry partners to continue the development of this project.
The Company has continued to develop the pharmaceutical potential of Colostrinin™ by carrying out pre-clinical studies at the University of Texas Medical Branch (UTMB) on the constituent peptides of the Colostrinin™ complex. Peptide activity in genes connected with the regulation of Alzheimer’s disease, obesity, hypertension and asthma has been discovered. Discussions are currently proceeding as to how this project may be taken forward.
Bolstering the pharmaceutical development side of the Company, in February 2006 ReGen acquired the rights to develop a new use for the long-established pharmaceutical drug zolpidem for the treatment of brain dormancy/diaschesis from a UK-based company Sciencom Ltd.
The clinical effect discovered in a number of ‘open’ clinical case observations in South Africa was that zolpidem can normalise areas of brain dormancy secondary to a primary lesion in brain damage conditions. The clinical effects of this dormancy reversal have been restoration of consciousness, swallowing, co-ordination and motor function after stroke and traumatic brain injury. Given that stroke alone is the largest single cause of severe disability in England and Wales, with over 250,000 people being affected at any one time, the Company believes that this represents a significant medical and commercial opportunity.
ReGen released findings of its own clinical study on zolpidem in South Africa, in August 2007. This trial involved 20 patients with various debilities as a consequence of brain damage. The study compared various single doses of a novel sublingual spray formulation with an existing tablet formulation in terms of the onset and degree of sedation. The results of the study showed clear evidence that a spray is absorbed faster and more completely than tablets, which will enable patients to control the effect more accurately. Most importantly a dose of 2.5mg caused no more sedation than placebo, suggesting the possibility that repeated 2.5mg spray doses will show efficacy without undue sedation. Based on these results, ReGen is reviewing options to continue the development of novel zolpidem formulations for the treatment of brain dormancy. Most recently a completely independent study at the University of Pretoria, South Africa, reported to the market in November 2009, gave further evidence of the activity of zolpidem in this area.
As a small company ReGen has outsourced a large part of its development work and has or has had a number of scientific development collaborators worldwide. In particular ReGen has a long-term relationship with the University of Texas Medical Branch in Galveston, Texas, where Dr Marian Kruzel, the Chief Scientific Officer of ReGen, is an Associate Professor. Other collaborators have included the Roswell Park Cancer Institute, Buffalo, New York State in the USA and the Open University, Milton Keynes (‘OU’), Aston University and Professor Ralf Clauss of the Department of Nuclear Medicine, Royal Surrey County Hospital in the UK.
As a result of its significant scientific development work ReGen has filed a substantial number of patent applications with various patent authorities throughout the World. These patents are targeted at protecting both discoveries in the field of the treatment of Alzheimer’s disease, at wider applications for Colostrinin™ and its constituent peptides in other neurodegenerative disease areas and, more recently, to protect the discovery of a new use for zolpidem in brain trauma. Most of the patent applications are still in the process of examination by individual national patent authorities, but by the end of 2009, the main “use” patent for Colostrinin™ has been granted in the United Kingdom, USA, Australia, New Zealand, Russia, China, Turkey, Israel, South Korea, Czech Republic, South Africa and Singapore. The process patent, covering the proprietary manufacture of Colostrinin™, has been granted in most EU countries (Belgium, Cyprus, Germany, Spain, France, United Kingdom, Greece, Italy and Poland), Switzerland and New Zealand. The main "use" patent for zolpidem has been granted in South Africa. This patent portfolio protects the Company’s Intellectual Property.
ReGen is also interested in sourcing new business oppofrtunities by securing development rights to commercially interesting projects and through the acquisition of individual companies whose assets or business show potential for future success. For example, the Company acquired Sciencom Ltd in 2006, which secured the rights to develop the new use for zolpidem. In addition to the acquisition of Sciencom, the ReGen management have reviewed a number of other prospective targets in the past and will continue to be active in this area in the future.
Last updated: 9th July 2010
