Targeted Genetics' Partner Celladon Corporation Reports 12 Month Follow Up Data from Phase 2 Clinical Trial of Patients Treated With MYDICAR
Sustained Clinical Improvements in Patients
SEATTLE--(BUSINESS WIRE)--Nov 15, 2010 - Targeted Genetics Corporation (Pink Sheets: TGEN.PK) (“Company”) announced that its partner, Celladon Corporation, today presented 12-month data from its Phase 2 CUPID clinical trial of MYDICAR® demonstrating significant improvements in clinical outcomes and key disease markers in advanced heart failure patients treated with the genetically-targeted enzyme replacement therapy.
Celladon presented the following data and results at the American Heart Association annual meeting in Chicago today:
- The study of 39 patients met its
primary safety and efficacy endpoints at 6 months for high dose
MYDICAR versus placebo. Additionally, after 12 months of receiving
a single infusion of MYDICAR, patients treated with the highest
dose versus placebo had an 88 percent risk reduction (Hazard Ratio
= 0.12, P=0.003), of major cardiovascular events such as:
- Need for left ventricular assist device (LVAD) or cardiac transplant
- Episodes of worsening of heart failure
- Number of heart failure-related hospitalizations
- The mean duration of hospitalization in the MYDICAR high dose group during the 12-month period was 0.4 days per patient compared with 4.5 days per patient in the placebo group. This finding is especially noteworthy because heart failure is the leading cause of hospitalization in Americans 65 and older.
- Additionally, the 12-month CUPID data show that heart failure, which is a progressive disease, became stabilized in high dose MYDICAR-treated patients: heart failure symptoms, exercise tolerance, serum biomarkers and cardiac function essentially improved or remained the same while these parameters deteriorated substantially in patients treated with placebo and concurrent optimal drug and device therapy.
To learn more about the data presented by Celladon, visit Celladon's Web site at www.celladon.net.
The Company and Celladon first entered into collaboration and manufacturing agreements in 2004. In 2009, Targeted Genetics licensed its adeno-associated virus (AAV) vector serotype and manufacturing technology to Celladon and manufactured clinical supplies of MYDICAR. Under the 2009 license agreement between Targeted Genetics and Celladon, Targeted Genetics could receive milestone payments and royalties on sales of MYDICAR if MYDICAR is successfully developed and commercialized.
Targeted Genetics Corporation announced on November 12, 2010 that it has entered into definitive agreements related to the acquisition of Biocontrol Ltd., or Biocontrol. Under terms of the proposed business combination, Targeted Genetics will issue shares of its common stock to the shareholders of Biocontrol such that after completion of the transaction Biocontrol will be a wholly-owned indirect subsidiary of Targeted Genetics, and Biocontrol's former shareholders will own approximately 50% of the resulting outstanding equity securities of Targeted Genetics. Upon completion, the combined company will develop the Biocontrol science and programs and capitalize on Targeted Genetics' AAV assets.
About Targeted Genetics Corporation
Targeted Genetics Corporation is a biotechnology company committed to the development and commercialization of innovative therapies for the prevention and treatment of diseases with significant unmet medical need.
To learn more about Targeted Genetics, visit Targeted Genetics' website at www.targetedgenetics.com.
Celladon Corp., based in La Jolla, Calif., was launched in October 2004 as a privately held biotechnology company with the goal of becoming the leader in developing molecular therapies for the treatment of heart failure. The company's products target calcium cycling and contractility deficit in heart muscle cells. In addition to MYDICAR®, Celladon is developing traditional small molecule activators of SERCA2a for the treatment of heart failure. To learn more about Celladon and MYDICAR, visit Celladon's Web site at www.celladon.net.
CERTAIN FORWARD-LOOKING STATEMENTS AND FACTORS THAT MAY AFFECT FUTURE RESULTS
This press release contains certain forward-looking statements concerning the Company's financial position and results of its third-party licensees, including without limitation, Celladon Corporation's product development efforts, and the potential future impact of such product development efforts, if any, on the Company. These forward-looking statements involve significant risks and uncertainties. Although the Company believes that the expectations reflected in such forward-looking statements are based on reasonable assumptions, readers are cautioned that the Company can provide no assurances that such expectations will prove correct and that actual results and developments may differ materially from those conveyed in such forward-looking statements. Factors that could cause actual results to differ materially from the expectations reflected in the forward-looking statements in this press release include, but are not limited to, the risk that the MYDICAR program data will not support further development of the product, that MYDICAR product development will be unsuccessful or not continue as planned, on the timeline anticipated, or at all, the risks that Biocontrol may not obtain sufficient acceptance of the Company's offer, the risks that a condition to closing of the combination with Biocontrol may not be satisfied, of litigation related to the merger of the Company with Biocontrol, of the Company's or Biocontrol's inability to resolve litigation related to the merger, that the combination will not be consummated within a reasonable period of time (or at all), the risk that the combined Company's current financial resources and future financial resources (if any) will be insufficient to enable the Company to fund continuing operations, the risk that the combined Company will not receive anticipated future revenue streams, the risk that the combined Company will run out of cash earlier than expected, the risk that the Company will not receive milestone or other payments from the Company's product development partners and collaborators or that the combined Company's and its collaborators' product development efforts will be unsuccessful, and the risks of accomplishing the combined Company's business plan,In addition, the Company has deregistered its common stock and is no longer subject to certain periodic financial reporting obligations with the Securities and Exchange Commission. Accordingly, the financial data available to the public in respect to the Company are dated, the Company is under no current obligation to update such data, and such data cannot be relied upon to accurately reflect the Company's current or future financial condition or results of operations.
Contact: IR/PR enquiries on behalf of Targeted Genetics
Corporation and Biocontrol Ltd.:
College Hill Life Sciences
Rebecca Skye Dietrich, +1-857-241-0795
Melanie Toyne Sewell, +44 207 457 2020
Gemma Howe, +44 207 457 2020
Posted: November 2010