Richard A. Franco, Sr. Appointed as Chief Executive Officer and Director
DARA Files Investigational New Drug Application ("IND") With the United
States Food and Drug Administration ("FDA") for DB959
KRN5500 Nears Completion of Its Phase 2a Study in Cancer Patients
RALEIGH, N.C., Feb. 5, 2009 (GLOBE NEWSWIRE) -- Today DARA BioSciences, Inc. (Nasdaq:DARA) reported on its ongoing operations.
New Capital -----------
DARA BioSciences, Inc. ("Company") announced on January 30, 2009 that it consummated a stock purchase and loan agreement and related agreements (the "Purchase and Loan Agreement") with SurgiVision, Inc. ("SurgiVision") pursuant to which DARA received $1,000,000 of total proceeds. These proceeds, together with cash on hand and the anticipated sale proceeds for the Company's shares of MiMedx Group, Inc. (OTCBB:MDXG), which become freely saleable by the Company in February 2009, will be used as working capital for the Company to continue operations according to its previously reported plan to reduce capital spending, conserve cash and prudently add value of its therapeutic assets. While the trading volume and attendant liquidity of the MiMedx shares is currently low, the Company believes that the MiMedx trading volume may soon increase since "lock-up" agreements encumbering the vast majority of MiMedx shares will expire in February.
Continuing SurgiVision Investment
In addition, DARA owns approximately 7.7% of SurgiVision, Inc., a private medical device company focused on developing and commercializing interventional magnetic resonance imaging (MRI) technologies. On April 15, 2008, Boston Scientific announced a licensing and development arrangement with SurgiVision for MRI-safe technology. As stated in that press release, physician implanters have consistently mentioned MRI-safe cardiac devices as a primary unmet clinical need. Under the arrangement, Boston Scientific gained access to SurgVision's development capabilities and obtained a license to SurgiVision's intellectual property for potential use in its implantable cardiac devices. As also reported by Boston Scientific, in December 2005, Boston Scientific and SurgiVision entered into a separate licensing and development agreement in the area of neuromodulation. DARA has been an investor in SurgiVision since 2004.
Changes in Officers and Directors ---------------------------------
Steve Gorlin submitted his resignation as a Director of the Company's Board of Directors effective as of January 26, 2009. Mr. Gorlin did not indicate that his resignation was the result of any disagreement with the Company on any matter relating to the Company's operations, policies or practices.
Effective on January 26, 2009, Richard Franco was appointed to fill the vacancy on the Board of Directors of the Company that was created when Mr. Gorlin resigned and was appointed as the Company's Chief Executive Officer. Mr. Franco has agreed to serve in these capacities for nominal consideration.
Certain biographical information concerning Mr. Franco is set forth below.
Richard A. Franco, Sr. (66) is returning to DARA, having previously served as the Company's Chairman of the Board from October 2007 to March 2008 and as President, Chief Executive Officer since January 1, 2007 and President and member of its Board of Directors since 2005. Before joining the Company in 2005, Mr. Franco served as a consultant. In 1997, Mr. Franco co-founded LipoScience, Inc., a private medical technology and diagnostics company, and served as President, CEO and Chairman of that company from 1997 to 2001 and as its Executive Chairman until 2002. Prior to founding LipoScience, he was President, CEO and Director of Trimeris, Inc., a biopharmaceutical company (Nasdaq:TRMS). He spent twelve years at Glaxo, Inc. (now Glaxo SmithKline) in increasing executive positions and was a member of the Glaxo Inc. Executive Committee. Before joining Glaxo, Mr. Franco was with Eli Lilly and Company for sixteen years. Mr. Franco currently is a Director of Salix Pharmaceuticals, Ltd., (Nasdaq:SLXP) a specialty pharmaceutical company; NeoMatrix, LLC, a private medical technology company commercializing screening systems for breast cancer risk detection; and the Research Triangle Chapter of the National Association of Corporate Directors (NACD). He has served on the Boards of TriPath, Inc. (Nasdaq:TPTH), EntreMed, Inc. (Nasdaq:ENMD), Tranzyme, Inc. and The United Way of Wake County and as a three time Distinguished Judge for The Entrepreneur of the Year for the Carolinas. Mr. Franco earned a Bachelor of Science degree in pharmacy from St. John's University and did his graduate work in pharmaceutical marketing and management at Long Island University.
Product Development Update --------------------------
On February 4, 2009, DARA filed an Investigational New Drug (IND) Application for DB959 with the United States Food and Drug Administration (FDA) for the treatment of Type 2 Diabetes Mellitus (T2D). This filing represents a significant milestone in the development of this first-in-class compound. DB959 is a dual PPAR delta/gamma agonist licensed from Bayer Pharmaceuticals in 2007. The unique combination of the delta/gamma agonist activities gives this therapeutic candidate the potential to provide cardiovascular benefit to Type 2 diabetes patients. In non-clinical studies DB959 demonstrated the potential to control blood sugar, raise good HDL cholesterol, lower triglycerides, lower total cholesterol and improve the HDL: LDL ratio. DB959Na is planned to be tested as both monotherapy and in combination with other standard glucose lowering agents such as metformin, dipeptidyl-peptidase IV inhibitors, sulphonylureas, and metformin/SU combinations. Once the IND is approved, and subject to DARA's raising additional capital necessary to fund further clinical development, DB959 would be DARA's second therapeutic candidate to advance to the clinical trial stage.
KRN5500 is the lead product candidate for DARA and it is anticipated that the Company will complete its Phase 2a trial in cancer patients with neuropathic pain by Q2 2009. This trial is fully enrolled and the last patient is expected to complete dosing by mid-February. Further development work beyond the completion of this Phase 2a study will be dependent upon DARA's obtaining necessary additional funding.
KRN5500 is being positioned for a high value niche segment of the neuropathic pain market including the treatment of Chemotherapy-induced peripheral neuropathy (CIPN) and other cancer related neuropathic pain. Chemotherapy-induced neuropathic pain occurs in 38% of patients treated with polychemotherapy and complete resolution of pain with existing agents is rare. (Ref: J Neurol, 249: 9-17, 2002., Oncology (Huntington),4: 57-62, 1990., Ann Neurol, 35: 305-311, 1994.). Effective treatment of neuropathic pain is one of the greatest unmet needs in cancer pain treatment. Should KRN5500 illustrate incremental effectiveness for these patients, it could have an important impact on a sizable number of cancer patients.
About DARA BioSciences, Inc.
DARA BioSciences(tm), Inc. ("DARA") is a Raleigh, North Carolina-based development-stage pharmaceutical company that acquires and develops promising drug candidates. DARA focuses its therapeutic development efforts on small molecules from late preclinical development through phase 2 clinical trials. DARA has a portfolio of drug candidates for neuropathic pain, type 2 diabetes, and psoriasis. For more information please contact the Company at 919-872-5578 or visit our web site at www.darabio.com.
About SurgiVision, Inc.
SurgiVision is a leading developer of next-generation MRI technologies, focused on MRI-safety and MRI-guided therapeutic interventions for neuromodulation, cardiac EP and localized delivery of cell/drug therapies.
About MiMedx, Inc.
MiMedx Group, Inc. (OTCBB:MDXG) is an integrated developer, manufacturer, and marketer of uniquely patented spine and orthopedic implants, which may represent breakthroughs in the treatment of trauma and disease. For more information, please visit: http://www.mimedx.com/.
All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934 as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Those factors include risks and uncertainties relating to DARA's current cash position and its need to raise additional capital in the near term in order to be able to continue to fund its operations, risks and uncertainties relating to DARA's ability to develop and bring new products to market as anticipated, the current regulatory environment in which the company develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property, the intellectual property of others, and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission. Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.