Endovasc - a biotechnology company with two cardiovascular drugs approved for final FDA Phase III trials - announced that it has established a new subsidiary, Nutriceutical Development Corporation (NDC), for its potential blockbuster nicotine and/or lobeline-based non-prescription products.
The company said this would make NDC the first company to focus on stem cell recruitment-based nutraceuticals, effectively differentiating it from traditional nutraceutical companies including Wyeth and Novavax.
According to Endovasc, nicotinic acetylcholine receptor (nAChR) agonist appears to have the "amazing ability" to recruit and mobilise the body's endogenous (its own) stem cells.
"We are in the process of analysing various safe, natural plant nutraceuticals that may recruit stem cells including low level (S)-nicotine Angiogenix, lobeline, carbamyl, natural choline esterase inhibitors, and others. Angiogenix certainly is not the only nAChR agonist but it is the most studied and appears to be safe and effective as a therapeutic drug. It is used at levels far below those generally thought to produce habituation or euphoria," said Dr David Summers, chairman and CEO of Endovasc.
"It has proven very effective as a therapeutic angiogenic at microgram (one millionth of a gram) and nanogram (one billionth of a gram) levels. We hardly think these levels will produce any of the typical effects of cigarette smoking or chewing tobacco. But if during experiments, these low levels produce any negative systemic effects (typically a cigarette smoker will ingest up to 25 mg per day) we will either reduce the levels below the microgram level to nanogram levels we found almost as effective. The other option would be to switch to a similar agonist such as lobeline, which has no addictive potential," added Summers.
He said that the company was confident it could avoid the deleterious effects of nicotine by using levels too low to have negative effects. "When combined with natural amino acids such as L-arginine and proteins such as creatine and other high protein complexes, the synergy of these compounds could produce blockbuster non-prescription products, resulting in positive cash flow even sooner than our later stage pharmaceutical therapies because they are not subject to the FDA approval process," said Summers.
The current market size for US nutraceuticals is estimated to be approximately $28 billion (€28.3bn) annually. Functional beverages represent the most significant growth area in the functional food market.
Endovasc recently announced that it has completed animal experiments that demonstrated that its nicotine-based Angiogenix treatment stimulates growth of new blood vessels and may grow new heart tissue. The studies would suggest that Angiogenix may also cause new cells to develop muscle mass and promote body fitness through stem cell recruitment.
"Development of muscle mass and body fitness alone is a multi-billion dollar industry worldwide. Myriad nutraceutical supplements and pharmacological medicines are used to restore, augment and repair body tissues for both aesthetic and medical purposes. For example, stroke victims with muscle dystrophy require extensive rehabilitation of muscle use during recovery in order to restore muscle mass. Fitness devotees and athletes seek to increase stamina, strength and muscle force to enhance personal appearance or performance," said Summers.
Endovasc's NDC subsidiary also plans to enter the $1 billion weight-loss drug market by developing is own anti-obesity non-prescription drug for obese diabetic women. The drug will be based on Endovasc's experience with Liprostin. The prescription Liprostin might be potentate when supplemented with gamma-linolenic acid (GLA), the precursor to PGE-1 and omega-3 fatty acids in a non-prescription formulation, said the company.
"We have found that PGE-1 combined with some other natural minerals and natural supplements may provide a much needed, natural solution for obesity. We believe that targeting diabetic obesity with natural Omega-3 essential fatty acids (EFAs) and raising the ratios of good prostaglandin may result in keeping insulin within a tight zone by countering the effects of hyperinsulemia with PGE-1," continued Summers.
Endovasc, established in 1996, focuses on taking on promising drug candidates at the end of the discovery phase and then conducting a fast track programme for the technical and early clinical development phases, covering Phases I and II of the compound.