ChromaDex Initiates Second Human Clinical Study for its Caffeine Ingredient, PURENERGY? - Applied Clinical Trials

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
ChromaDex Initiates Second Human Clinical Study for its Caffeine Ingredient, PURENERGY? - Company expects numerous retail products to be launched in 2014 that incorporate PURENERGY® as an alternative ingredient to caffeine -


ChromaDex Initiates Second Human Clinical Study for its Caffeine Ingredient, PURENERGY®

- Company expects numerous retail products to be launched in 2014 that incorporate PURENERGY® as an alternative ingredient to caffeine -

PR Newswire

IRVINE, Calif., May 13, 2014 /PRNewswire/ --  ChromaDex Corp.  (OTCQB: CDXC), an innovative natural products company that provides proprietary ingredients and science-based solutions to the dietary supplement, food and beverage, animal health, cosmetic and pharmaceutical industries, announced today the initiation of the second human clinical study for PURENERGY ® , its patented caffeine ingredient. 

The Institutional Review Board (IRB)-approved, crossover design study will be administered by Medicus Research and will build on the results from the first PURENERGY ® human study, which was performed in the summer of 2013. The new clinical trial will study the bioavailability and pharmacokinetics of PURENERGY ® as compared to caffeine and pTeroPure® pterostilbene alone at repeated doses.

PURENERGY ® is an innovative patented caffeine ingredient that is a cocrystal combination of caffeine and ChromaDex's patented pTeroPure® pterostilbene.  The combination forms a unique crystalline structure that has superior benefits as compared to caffeine alone. Recently, caffeinated energy products have come under increased regulatory and political scrutiny because of the possible risks associated with consuming high amounts of caffeine.  PURENERGY ® offers product formulators a unique solution to reduce total caffeine content while optimizing the consumer experience – as well as delivering the benefits of pTeroPure® .

Frank L. Jaksch Jr., CEO of ChromaDex, commented, "This study will provide additional valuable insight into the benefits of PURENERGY ®, building on our previous successful human study.  We have already had tremendous interest in PURENERGY ® and anticipate seeing numerous retail products launched in 2014 and beyond that incorporate PURENERGY ® as a compelling alternative ingredient to caffeine alone."

Results from the first study conducted in 2013 showed that PURENERGY ® delivers 30 percent more caffeine to the bloodstream and also extends the half-life of caffeine by 25 percent as compared to caffeine alone.  The study results suggest:

  • Formulators of energy products have the ability to reduce the total amount of caffeine in their products without sacrificing consumers' expectations from such products.
  • A rapid and sustained energy boost for at least six hours.

In addition to serving as a caffeine alternative, PURENERGY™ has additional health benefits stemming from its cocrystal formulation with ChromaDex's patented pTeroPure® pterostilbene, which has shown great promise for supporting heart health, cognitive function, anti-aging, weight loss and other metabolic functions. The findings from the first clinical trial of the pure compound, which were presented in September 2012 at the American Heart Association's High Blood Pressure Research 2012 Scientific Sessions, showed that pTeroPure® (pterostilbene) significantly reduced blood pressure in adults. pTeroPure® was named the 2010 North American Most Promising Ingredient of the Year by the independent research company Frost & Sullivan. 

About ChromaDex:
ChromaDex is an innovative natural products company that discovers, acquires, develops and commercializes proprietary-based ingredient technologies through its unique business model that utilizes its wholly owned synergistic business units, including ingredient technologies, natural product fine chemicals (known as "phytochemicals"), chemistry and analytical testing services and product regulatory and safety consulting (as Spherix Consulting). The company provides seamless science-based solutions to the nutritional supplement, food and beverage, animal health, cosmetic and pharmaceutical industries. The ChromaDex ingredient technologies unit includes products backed with extensive scientific research and intellectual property. Its ingredient portfolio includes pTeroPure® pterostilbene; ProC3G®, a natural black rice containing cyanidin-3-glucoside; PURENERGY ®, a caffeine-pTeroPure® co-crystal; and NIAGEN™, its recently launched branded nicotinamide riboside, a novel next-generation no-flush B vitamin. To learn more about ChromaDex, visit www.chromadex.com.

Forward-Looking Statements:
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company's business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2013, the Company's Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

ChromaDex Media Inquiries:                                               
Beckerman PR                                                                        
Jerry Schranz                                                                          
201-465-8020                                                                         
jschranz@beckermanpr.com   

ChromaDex Company Contact:
Laura Kelly, Executive Assistant
949-419-0288
laurak@chromadex.com

Statements in this press release have not been evaluated by the Food and Drug Administration.  Products or ingredients are not intended to diagnose, treat, cure or prevent any disease.

SOURCE ChromaDex Corp.

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

UPCOMING CONFERENCES

8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
87%
Borrow lightly from EMA's pathway program?
6%
Create entirely its own pathway program?
8%
View Results
Untitled Document

Click here