DiaMedica Completes Enrollment in Phase II Clinical Trial for DM-83
May 05, 2008
May 5, 2008 (Marketwire) - DiaMedica Inc. (TSX VENTURE:DMA), a drug discovery and development company focused on novel treatments for Type 2 diabetes, today announces that it has enrolled the final patient in the phase II proof of concept clinical trial of DM-83.
Mr. Rick Pauls, DiaMedica's Interim President and CEO, said the twenty patient single-blind trial will demonstrate DM-83's level of effectiveness in controlling blood glucose and insulin levels in Type 2 diabetic patients after they have consumed a standard meal. Changes in insulin and glucose levels are the study's primary endpoints. Each patient will test both the effects of DM-83 as well as a placebo and therefore serve as their own control in this crossover study. All patients have now completed treatment and last patient is expect to complete the study in the second quarter with results to be analyzed and released shortly thereafter. The results of this trial will be used to optimize the design of the next stage of clinical development for DM-83.
"One of the key strengths of the Company's business platform is our ability to move drug candidates into clinical trials more quickly than traditional drug development", stated Mr. Pauls. "This is because we are using compounds that have already been approved for use in humans. The fact that DM-83 is a combination of two such compounds has allowed us to move it into a phase II trial in an expedient manner".
The inability to use insulin produced by the pancreas is a significant problem for people who suffer from Type 2 diabetes. This is demonstrated by the fact that many Type 2 diabetics have high levels of both glucose and insulin circulating in their bloodstream. DiaMedica believes that restoring insulin sensitivity and allowing the body to use its own naturally produced insulin is the key to combating this illness. Preclinical animal studies have demonstrated that DM-83 is able to restore insulin sensitivity to near pre-diabetic levels and has been shown to be safe.
Diabetes is a widespread and rapidly growing disease, affecting over 180 million people world wide with over 90% of diabetics being diagnosed with the Type 2 form of the disease. According to the World Health Organization this number is expected to double during the next 15 years while the American Diabetes Association has estimated the annual economic cost in 2007 to the United States to be $174 billion. Global sales of oral diabetes drugs total $6 billion today and are expected to climb to $11 billion by 2011.
About DM-83
DM-83 has demonstrated the ability to restore insulin sensitivity in an animal model of diabetes. The product is a novel combination of two known compounds with well established safety profiles that are used to treat other unrelated human conditions, one of which is used to improve cardiovascular conditions. Studies have shown that neither compound is able to restore insulin sensitivity on its own, while combining the two results in a synergistic effect that restores insulin sensitivity to pre-diabetic levels.
About DiaMedica
DiaMedica is developing novel treatments for various stages of type 2 diabetes. The Company recently completed a phase II clinical trial with its lead product DM-71 which demonstrated the ability to reduce HbA1c levels in man. The Company has two other drugs in its clinical pipeline, DM-83 and DM-99, which are moving through phase II proof of concept clinical studies.
Caution Regarding Forward-Looking Information
Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, our anticipated future operating results, and can, in some cases, be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
These statements reflect management's current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: DiaMedica's early stage of development, lack of product revenues and history of operating losses, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition, potential product liability, additional financing requirements and access to capital, unproven markets, supply of raw materials, income tax matters, management of growth, partnerships for development and commercialization of technology, effects of insurers' willingness to pay for products, system failures, dependence on key personnel, foreign currency risk, risks related to regulatory matters and risks related to intellectual property and other risks detailed from time to time in DiaMedica's filings with Canadian securities regulatory authorities, as well as DiaMedica's ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release, as well as under the heading "Risk Factors" contained in DiaMedica's final long-form prospectus dated March 12, 2007. DiaMedica cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on DiaMedica's forward-looking statements to make decisions with respect to DiaMedica, investors and others should carefully consider the foregoing factors and other uncertainties and potential events.
These risks and uncertainties should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, DiaMedica cannot provide assurance that actual results will be consistent with these forward-looking statements. DiaMedica undertakes no obligation to update or revise any forward-looking statement.
The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
Posted by dlife at 09:59 AM | Comments (0)
Smiths Medical MD, Inc. Issued a Voluntary Recall of Specific Serial Numbers of the Deltec Cozmo® Insulin Pump
March 10, 2008
March 10, 2008 (Cozmo) - Smiths Medical MD, Inc. today issued a voluntary recall of specific serial numbers (see below) of the Deltec Cozmo® Insulin Pump.
Only 1023 recently manufactured pumps have been affected by this recall. These pumps were manufactured between November 2007 and January 2008. We have only been notified of 2 occurrences by customers, none of which have required any medical intervention
The reason for this recall is that the pumps may have an issue that affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user. Smiths Medical will be replacing all affected pumps.
After conducting a thorough investigation, Smiths Medical has concluded that the root cause of the motor issue was a manufacturing error with its component supplier. Through process control and process validation, this issue has now been corrected.
We will be notifying customers by mailing the recall letter via regular US Post and by telephoning customers. The Food and Drug Administration (FDA) has been informed of this action.
Any customer inquires related to this action should be addressed to Smiths Medical's customer service center at 1-800-826-9703.
Serial numbers for affected Deltec Cozmo® Insulin Pumps can be found here.
Posted by dlife at 03:18 PM | Comments (1)
Joslin Study Finds Increased Use of Insulin Pumps, New Insulin Types Give Teens More Tools to Better Manage Diabetes
February 27, 2007
Feb. 27, 2007 (Joslin) - It is widely recognized that the teenage years are often a challenging time for youth with diabetes to maintain good blood glucose control. Hormonal changes, peer pressure, food temptations, and resistance to following good health practices are among the factors that make it difficult for many youngsters. Unfortunately, poor diabetes control places youth at increased risk of developing complications from diabetes later in life.
The landmark Diabetes Control and Complications Trial, which ended in 1993, confirmed the long-held belief of Joslin's founder, Elliott P. Joslin, M.D., that good blood glucose control is necessary to help stave off diabetes-related complications, such as heart disease, blindness and nerve damage. Among the 1,441 people evaluated in the DCCT, about 200 were adolescents. It was not surprising that this small group generally had higher blood glucose levels than the adults.
Now a new study led by Lori Laffel, M.D., M.P.H., and her colleagues in Joslin Diabetes Center's Pediatric, Adolescent and Young Adult Section reveals some good news for youngsters with type 1 diabetes. The study found that adolescents are doing a better job controlling their blood glucose levels than they were previously, thanks in part to tools like insulin pumps and insulin analogs that have become available in recent years. The study appears in the March edition of the Journal of Pediatrics.
"The good news is that we have shown that teens are able to better control diabetes than they were in the DCCT study," said Dr. Laffel, Chief of Joslin Pediatrics, Investigator in the Genetics and Epidemiology Section and Associate Professor of Pediatrics at Harvard Medical School.
The researchers studied more than 400 youth with type 1 diabetes who were ages 8 to 16 years and divided into two groups. The first group of 299 youngsters began being studied in 1997; the second group of 152 began being followed by the researchers in 2002. Each group was followed for a two-year period. As five years separated the two study groups, the researchers were able to track the improvements in control from the first group to the second group.
"We found about 40 percent of the first group were checking their blood glucose at least four times per day, and in the second group, it was 72 percent," Dr. Laffel said. In regard to insulin delivery systems, no patients in the first group were on insulin pumps when they entered the study, compared to 23 percent of the youth in the second group.
The researchers also found fewer hospitalizations, emergency room visits and severe low blood glucose episodes (hypoglycemia) with the second group. Furthermore, they did not see evidence of increased weight gain with the second group, which can be associated with increased intensity of insulin usage.
The improved control paid off for the second group with lower A1C values, which reflect a patient's average blood glucose over several months. The average A1C at the start of the study was 8.7 percent for the first group, compared to 8.4 percent for the second group. Furthermore, only 30 percent of patients in the first group met a target A1C of 8 percent or below, while close to half of the patients in the second group met this goal. "Of course there's still room for improvement. We want to see 100 percent of patients achieving tight control," said Dr. Laffel. "Nonetheless, there was considerable improvement between the two groups," she added.
"While it took the general medical community some time to adopt intensive therapy and to provide patients and families with the skills necessary to carry out tight diabetes control, we at Joslin were quick to translate the DCCT findings to clinical care," Dr. Laffel said. "In Joslin's pediatrics program, about 80 percent of patients were put on insulin analogs early on," she said.
"It's not acceptable that only half the people in the second group reached the A1C target goal. Further technologic advances are still needed. For example, we are excited to be starting two new studies at Joslin evaluating the use of continuous glucose monitoring devices. We hope that this technology will be able to further help our patients achieve
Posted by dlife at 04:09 PM | Comments (3)