Dimethaid presents Phase III results at the British Society for Rheumatology and receives notice of completion of the Assessment Report

Apr 26, 2001, 01:00 ET from Dimethaid Research Inc.

    TORONTO, April 26 /PRNewswire/ - Dimethaid Research Inc. (TSE: DMX)
 announced that results of a second large, multi-center Phase III clinical
 study of PENNSAID(R) (diclofenac) Topical Solution were presented at the 18th
 Annual General Meeting of the British Society for Rheumatology (BSR), held in
 conjunction with the Scandinavian Society for Rheumatology in Edinburgh,
 Scotland. This study added to the data available from previous studies, by
 including a larger number of patients, a longer time period and expanded
 primary measures of osteoarthritis to show that PENNSAID(R) is effective in
 the site-specific treatment of the symptoms of primary osteoarthritis of the
 knee. This study further demonstrated the ability of PENNSAID(R) to improve
 physical function and provide significant pain relief, without the potential
 for negative, systemic side effects commonly associated with oral non-
 steroidal anti-inflammatory medications (NSAIDs).
     PENNSAID(R) is the first product developed by Dimethaid Research to use
 its unique carrier technology, a proprietary transdermal delivery system that
 facilitates the site-specific delivery of drugs with minimal systemic
 absorption and only minor local irritation.
     The double-blind, placebo-controlled trial of PENNSAID(R) was conducted
 with patients suffering moderate to extreme pain in their osteoarthritic knee.
 The primary outcome measures were the pain and physical function subscales of
 the WOMAC OA Index as well as a patient global assessment. The WOMAC OA Index
 subscale of stiffness was used as a secondary outcome measure. The results
 showed statistically significant (p less than 0.05) improvement in all primary
 and secondary outcome measures for PENNSAID(R) versus control (the carrier
 without diclofenac).
     "The results of this study highlight our confidence that PENNSAID(R) can
 provide safe, effective relief of pain symptoms and improve the quality of
 life for patients suffering from osteoarthritis of the knee and is a viable
 alternative to oral medications," said Dr. J. Zev Shainhouse, Medical Director
 of Dimethaid Research. "Patients with mild to extreme pain from osteoarthritis
 now have the option of a topical treatment, without the risk of any serious
 side effects."
     The BSR is an organization for clinicians and scientists in rheumatology
 and related fields. The principal objective of the BSR is to advance the
 science and practice of rheumatology and to promote study and research through
 scientific meetings and education courses. The BSR publishes the international
 journal Rheumatology and has approximately 1400 members in the United Kingdom
 and overseas.
     The Medicines Control Agency (MCA) has advised Dimethaid that their
 written Assessment Report will be available for release during the week of
 April 30, 2001. This report will be submitted by the MCA to each of the
 following Concerned Member States (CMS) after Dimethaid International has
 submitted the consolidated EU Mutual Recognition applications to Austria,
 Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy,
 Luxembourg, Netherlands, Spain and Sweden. The commencement of the 60-day
 review period by these CMS will begin upon their receipt of the EU Mutual
 Recognition applications. If any queries are raised, the review period can be
 extended for an additional 30 days. The completion of the Assessment Report is
 therefore a significant milestone in the overall Mutual Recognition Process,
 which will allow the company to significantly expand the market potential for
 PENNSAID(R).
     Dimethaid Research Inc. is a pharmaceutical company engaged in the
 development and commercialization of innovative therapeutic products that
 offer the potential to minimize the unwanted systemic effects of drug therapy
 on the body. Dimethaid's proprietary drug delivery technology utilizes the
 cell's tubule system to deliver drugs cell-to-cell. As a result, patients are
 able to treat localized conditions, such as osteoarthritis, while limiting the
 body's absorption of, and associated risks from, the medication. This
 technology has been applied first to produce PENNSAID(R) Topical Solution. The
 Company's business development strategy is to leverage its proprietary
 transdermal delivery technology into additional commercial products. For
 additional information on the Company, please visit www.dimethaid.com.
     This release may contain forward-looking statements. Such statements
 involve known and unknown risks, uncertainties and other factors outside of
 management's control that could cause actual results to differ materially from
 those expressed in the forward-looking statements. A discussion of such risk
 factors is included in the Company's AIF filed with the OSC and includes,
 without limitation, risks regarding product development, clinical trials,
 dependence on third parties for development and licensing arrangements, and
 risks involving regulatory approval of products, licenses and patents. The
 Company undertakes no obligation to publicly revise these forward-looking
 statements to reflect subsequent events or circumstances.
 
 

SOURCE Dimethaid Research Inc.
    TORONTO, April 26 /PRNewswire/ - Dimethaid Research Inc. (TSE: DMX)
 announced that results of a second large, multi-center Phase III clinical
 study of PENNSAID(R) (diclofenac) Topical Solution were presented at the 18th
 Annual General Meeting of the British Society for Rheumatology (BSR), held in
 conjunction with the Scandinavian Society for Rheumatology in Edinburgh,
 Scotland. This study added to the data available from previous studies, by
 including a larger number of patients, a longer time period and expanded
 primary measures of osteoarthritis to show that PENNSAID(R) is effective in
 the site-specific treatment of the symptoms of primary osteoarthritis of the
 knee. This study further demonstrated the ability of PENNSAID(R) to improve
 physical function and provide significant pain relief, without the potential
 for negative, systemic side effects commonly associated with oral non-
 steroidal anti-inflammatory medications (NSAIDs).
     PENNSAID(R) is the first product developed by Dimethaid Research to use
 its unique carrier technology, a proprietary transdermal delivery system that
 facilitates the site-specific delivery of drugs with minimal systemic
 absorption and only minor local irritation.
     The double-blind, placebo-controlled trial of PENNSAID(R) was conducted
 with patients suffering moderate to extreme pain in their osteoarthritic knee.
 The primary outcome measures were the pain and physical function subscales of
 the WOMAC OA Index as well as a patient global assessment. The WOMAC OA Index
 subscale of stiffness was used as a secondary outcome measure. The results
 showed statistically significant (p less than 0.05) improvement in all primary
 and secondary outcome measures for PENNSAID(R) versus control (the carrier
 without diclofenac).
     "The results of this study highlight our confidence that PENNSAID(R) can
 provide safe, effective relief of pain symptoms and improve the quality of
 life for patients suffering from osteoarthritis of the knee and is a viable
 alternative to oral medications," said Dr. J. Zev Shainhouse, Medical Director
 of Dimethaid Research. "Patients with mild to extreme pain from osteoarthritis
 now have the option of a topical treatment, without the risk of any serious
 side effects."
     The BSR is an organization for clinicians and scientists in rheumatology
 and related fields. The principal objective of the BSR is to advance the
 science and practice of rheumatology and to promote study and research through
 scientific meetings and education courses. The BSR publishes the international
 journal Rheumatology and has approximately 1400 members in the United Kingdom
 and overseas.
     The Medicines Control Agency (MCA) has advised Dimethaid that their
 written Assessment Report will be available for release during the week of
 April 30, 2001. This report will be submitted by the MCA to each of the
 following Concerned Member States (CMS) after Dimethaid International has
 submitted the consolidated EU Mutual Recognition applications to Austria,
 Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy,
 Luxembourg, Netherlands, Spain and Sweden. The commencement of the 60-day
 review period by these CMS will begin upon their receipt of the EU Mutual
 Recognition applications. If any queries are raised, the review period can be
 extended for an additional 30 days. The completion of the Assessment Report is
 therefore a significant milestone in the overall Mutual Recognition Process,
 which will allow the company to significantly expand the market potential for
 PENNSAID(R).
     Dimethaid Research Inc. is a pharmaceutical company engaged in the
 development and commercialization of innovative therapeutic products that
 offer the potential to minimize the unwanted systemic effects of drug therapy
 on the body. Dimethaid's proprietary drug delivery technology utilizes the
 cell's tubule system to deliver drugs cell-to-cell. As a result, patients are
 able to treat localized conditions, such as osteoarthritis, while limiting the
 body's absorption of, and associated risks from, the medication. This
 technology has been applied first to produce PENNSAID(R) Topical Solution. The
 Company's business development strategy is to leverage its proprietary
 transdermal delivery technology into additional commercial products. For
 additional information on the Company, please visit www.dimethaid.com.
     This release may contain forward-looking statements. Such statements
 involve known and unknown risks, uncertainties and other factors outside of
 management's control that could cause actual results to differ materially from
 those expressed in the forward-looking statements. A discussion of such risk
 factors is included in the Company's AIF filed with the OSC and includes,
 without limitation, risks regarding product development, clinical trials,
 dependence on third parties for development and licensing arrangements, and
 risks involving regulatory approval of products, licenses and patents. The
 Company undertakes no obligation to publicly revise these forward-looking
 statements to reflect subsequent events or circumstances.
 
 SOURCE Dimethaid Research Inc.