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Akesis Pharmaceuticals Engages Quintiles and dgd Research for Clinical Services.


SAN DIEGO -- Akesis Pharmaceuticals, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:AKES AKES Allan Kardec Educational Society ), an emerging diabetes drug-development company, today announced it has engaged Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History
Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees.
 Transnational Corp and dgd Research to provide analytical and clinical services related to the Company's lead product candidate, AKP-020, otherwise known as bis(ethylmaltolato)oxovanadium (IV), or BEOV. Pending FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 review and approval, Quintiles will be responsible for overall project supervision and data management for upcoming trials, while dgd Research will be conducting the planned Phase Ib human clinical trials in its San Antonio facility.

"We are looking forward to beginning clinical research with BEOV later this year following the FDA's review of our plans," said Jay Lichter, Ph.D., president and chief executive officer of Akesis Pharmaceuticals. "Quintiles and dgd Research have considerable experience in managing and conducting the type of trials we have proposed to advance the development of AKP-020."

AKP-020 is a novel vanadium vanadium (vənā`dēəm), metallic chemical element; symbol V; at. no. 23; at. wt. 50.9415; m.p. about 1,890°C;; b.p. 3,380°C;; sp. gr. about 6 at 20°C;; valence +2, +3, +4, or +5. Vanadium is a soft, ductile, silver-grey metal.  compound that has shown considerable potential as a treatment for patients with Type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
. Data from a Phase I trial evaluating BEOV in healthy volunteers provided the clinical evidence of reasonable safety to support additional FDA-approved studies. Phase I data showed the compound has advantages over unpatented vanadyl sulfate sulfate, chemical compound containing the sulfate (SO4) radical. Sulfates are salts or esters of sulfuric acid, H2SO4, formed by replacing one or both of the hydrogens with a metal (e.g., sodium) or a radical (e.g., ammonium or ethyl).  with respect to dosing, pharmacokinetics and bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration.

bi·o·a·vail·a·bil·i·ty
n.
, without any apparent signs of toxicity.

About Quintiles

Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, financial partnering and commercialization for the pharmaceutical, biotechnology and healthcare industries. With 18,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit www.quintiles.com.

About dgd Research

dgd Research is a world leader in providing relevant patient populations to meet or exceed clients' study requirements while making a positive impact on the welfare and education of study participants. Formerly known as the Diabetes & Glandular glandular /glan·du·lar/ (glan´du-ler)
1. pertaining to or of the nature of a gland.

2. glanular.


glan·du·lar
adj.
1.
 Disease Research Associates, dgd Research also develops and delivers high-quality systems and services to support clinical decisions and outcomes, performing more than 1,500 Phase I-IV clinical trials in diabetes, hypertension, neuropathy, osteoporosis, cholesterol, obesity, menopause, and nephropathy nephropathy /ne·phrop·a·thy/ (ne-frop´ah-the) disease of the kidneys.nephropath´ic

analgesic nephropathy
 under the supervision of major pharmaceutical companies in accordance with FDA rules and regulations. dgd Research currently leads the U.S. market in Phase I endocrine/metabolic clinical trials and is fifth nationwide for Phase II-IV trials. For more information, please visit www.dgdresearch.com.

About Akesis

Akesis Pharmaceuticals has a pipeline of innovative oral product candidates for the treatment of diabetes and related metabolic disorders. These product candidates are supported by issued and filed U.S. patents for both prescription and over-the-counter treatments that combine anti-diabetic trace minerals with certain classes of diabetes oral agents. Akesis' product candidates have demonstrated preliminary evidence of efficacy in lowering and controlling blood glucose levels blood glucose level,
n level of glu-cose in the bloodstream, normally about 70 to 115 mg/dL after fasting overnight. Higher levels may indicate diseases such as diabetes mellitus.
 in patients with Type 2 diabetes. Blood sugar control via oral drugs represents a market opportunity in the billions of dollars, as reports indicate that approximately 20 million people suffer from diabetes in the United States alone. More information can be found at www.akesis.com.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can generally be identified as such because the context of the statement will include words such as "will", "expects", "should", "believes", "anticipates" or words or phrases of similar meaning. Examples of such statements include statements relating to the development of Akesis' product candidates, including AKP-020, and Akesis' ability to conduct additional FDA-approved studies relating to its product candidates, including AKP-020. Stockholders, potential investors and other readers are cautioned that these forward-looking statements are predictions based only on current information and expectations that are inherently subject to risks and uncertainties that could cause future events or results to differ materially from those set forth or implied by the forward-looking statements. Certain of those risks and uncertainties are discussed in Akesis' filings with the Securities and Exchange Commission, including Akesis' most recent annual report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 (as amended by its annual report on Form 10-K/A) and quarterly reports on Form 10-Q Form 10-Q

See 10-Q.
. These forward-looking statements are only made as of the date of this press release, and Akesis does not undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jul 11, 2007
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