Written by ι Stock Market Media Group Staff — October 3, 2013
Plandaí Biotechnology, Inc. (OTCQB: PLPL) has several clinical trials already underway, and a host of others scheduled to commence in the company months as the company feverishly prepares products for market in its transition from solely a research and development firm to a biotech with products in the marketplace. Plandaí has stated its goal is to have most of the trials it has commissioned completed by the end of March 2014 – which will serve to bolster sales efforts as customers are educated about the advantages of improved bioavailability.
All of these trials are crucial to the company getting its products in the marketplace, and commencing in January 2014, Plandaí says it should be producing Phytofare™ Catechin Complex at its Senteeko facility in South Africa. According to the company, some of the product will be shipped to a Pheroid™ production facility in South Africa for further processing. The Phytofare™/Pheroid™ products are currently being tested to ensure conformity to the company’s standard profile, before being released to market.
Company executives have estimated that its products will be ready to ship to customers in four different formulations after the clinical trials have been completed in March 2014. Those formulations include; Phytofare™ Catechin Complex, a water-soluble powder, Ph2™ Topical Catechin Complex, a topical cream that has Phytofare™ nano-entrapped in Pheroid™, Ph2™ Oral Catechin Complex, a gel tab version of Phytofare™ nano-entrapped in Pheroid™, suitable for oral consumption, and Ph2™ Liquid Catechin Complex, an oral version of Phytofare™ nano-entrapped in Pheroid™ in a liquid suspension, suitable for mixing into beverages and liquid medications.
The success of each of these formulations in the marketplace is somewhat contingent upon successful clinical trials, though it is impossible to anticipate all potential applications. Plandaí seems determined to focus first on trials that demonstrate the overall effectiveness of the various products in broad areas. In August, Plandaí started two clinical trials. The first includes 35 participants and focuses on the depth of penetration of the company’s Phytofare™ Pheroid™ Catechin Complex to demonstrate that Plandaí’s product can be effectively used in topical creams to deliver Phytofare™ into target tissues.
The second clinical trial which just commenced also includes 35 participants, and focuses on the anti-inflammatory properties of Plandaí’s Phytofare™ Pheroid™ Catechin Complex. The company’s goal is to show reduced redness and irritation in a topical application which will allow Phytofare™ to be used in various skin care products. Plandaí expects to have the results from these two trials within 3 months.
Plandaí has three more trials slated to begin this quarter. A 90 participant study that will measure the effectiveness of a 400mg daily dosage of Phytofare™ Pheroid™ Catechin Complex in promoting weight loss is scheduled to get underway in November. In the study Plandaí will be conducting full blood and urine panels to ascertain the impact of Phytofare™ on glucose, lipids, uric acid, hormones, and ketones.
Also, in November, Plandaí has an animal study scheduled to determine the effectiveness of a combination malaria drug that includes Phytofare™ Catechin and Phytofare Arteseminin, entrapped in Pheroid™. In vitro studies have shown that both catechins and arteseminin are effective at killing the malaria parasite, P. falciparum. The current gold standard for treating malaria infections is actually a synthetic derivative of arteseminin.
The company has a human clinical trial set to close out the quarter and 2013 that is designed to measure the effectiveness of the Phytofare™ Limonoid Glycoside Complex in both regular and Pheroid™ formulations in relieving cold and flu symptoms. The company is currently determining the specific parameters of the study, but it is currently expected to commence sometime in November or December.
Plandaí will start 2014 off with another two clinical trials. The first is expected to begin in January and will be a 35 participant human study focusing on the anti-aging properties of Phytofare™ Pheroid™ Catechin Complex. The study will test skin imperfections, elasticity, wrinkles, collagen production, etc., over a 90 day period. If the trial is successful, it will allow Phytofare™ to be used in various skin care products.
Just ahead of the company’s expected deadline to close out all of these clinical trials ahead of the sale of products, a 12 participant study will being in February and test the absorption of Phytofare™ and Phytofare™ Pheroid in human subjects. The goal of this study is to show the greater bioavailability of Phytofare™ products over standard extracts. Plandaí says this human study will be a 3 week study.