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March 17, 2008
SAN DIEGO--(BUSINESS WIRE)--Akesis Pharmaceuticals, Inc. (OTCBB:AKES), an emerging diabetes drug-development company, today disclosed preliminary data on patients in its placebo-controlled Phase IIa trial designed to test the safety and efficacy of AKP-020, a novel vanadium compound, in patients with Type 2 diabetes.
To date, Akesis has dosed an initial four Type 2 diabetic patients, two of whom were dosed with AKP-020 and two of whom were dosed with a placebo.
Fasting plasma glucose (mg/dL) |
|
|
|
Treatment |
|
Day -1 |
|
Day 2 |
|
Day 7 |
Subject 1 |
|
AKP-020 |
|
157 |
|
139 |
|
128 |
Subject 2 |
|
Placebo |
|
143 |
|
148 |
|
151 |
Subject 3 |
|
AKP-020 |
|
276 |
|
212 |
|
130 |
Subject 4 |
|
Placebo |
|
157 |
|
142 |
|
165 |
Oral glucose tolerance test (OGTT) plasma glucose (mg/dL) 2 hours after challenge |
|
|
|
Treatment |
|
Day -1 |
|
Day 2 |
|
Day 7 |
Subject 1 |
|
AKP-020 |
|
263 |
|
264 |
|
217 |
Subject 2 |
|
Placebo |
|
317 |
|
269 |
|
307 |
Subject 3 |
|
AKP-020 |
|
483 |
|
378 |
|
265 |
Subject 4 |
|
Placebo |
|
291 |
|
255 |
|
291 |
Day 1 data was collected the day before patients were dosed. Day 2 data was collected 24 hours after a single 20 mg oral dose of AKP-020 or placebo, and Day 7 data was collected after 7 daily administrations of 20 mg oral dose of AKP-020 or placebo.
The American Diabetes Association has defined that either of the following criteria is sufficient to establish the diagnosis of diabetes mellitus: 1) a fasting plasma glucose =126 mg/dL; 2) a 2-hour post-load glucose level of = 200 mg/dL during a 75-g OGTT. Diabetes Care Vol. 30 Suppl 1, Jan 2007, S42-S47.
“We are encouraged by these promising preliminary results, but we also recognize the early stage of our Phase IIa trial and continue to recruit patients and analyze the data,” said Jay Lichter, president and chief executive officer of Akesis.
dgd Research of San Antonio, TX, now a member of Cetero Research, is conducting the Phase IIa trial for AKP-020. The trial will enroll a total of 21 diabetic patients at a single site measuring efficacy (using the gold-standard euglycemic-hyperinsulinemic clamping procedure), as well as pharmacokinetic parameters, safety and tolerability of AKP-020 in diabetic patients.
AKP-020 is the product designation for a novel vanadium compound otherwise known as bis(ethylmaltolato)oxovanadium (IV), or BEOV. The compound was invented and developed by University of British Columbia researchers Chris Orvig, professor of chemistry and pharmaceutical sciences, and John McNeill, Ph.D., professor and dean emeritus, pharmaceutical sciences, and is licensed exclusively to Akesis Pharmaceuticals. Professors Orvig and McNeill, who are experts in the study of metal chemistry and pharmaceutical sciences, helped to advance the BEOV program through Phase I clinical trials. They also are members of the Akesis Scientific Advisory Board.
About Akesis Pharmaceuticals
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 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 results from Akesis’ Phase IIa clinical trial of AKP-020 and the continued operation of that trial. 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 (as amended by its annual report on Form 10-K/A) and quarterly reports on Form 10-QSB. 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.
Contacts
Akesis Pharmaceuticals, Inc.
Jay Lichter, Ph.D., President & CEO, 858-454-4311
jlichter@akesis.com
or
Lippert/Heilshorn & Associates
Don Markley, 310-691-7100
dmarkley@lhai.com
###
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