The Burrill Report


Palo Alto, California-based StemCells said that it has discontinued its early-stage clinical trial in Batten disease, a rare and fatal neurodegenerative disorder in children, due to its inability to recruit patients into the trial. In 2009, the company completed a phase 1 safety trial of its human neural stem cells in six patients with advanced stages of Batten disease at Oregon Health & Science University Doernbecher Children's Hospital. In October 2010, the Company initiated a phase 1b trial at OHSU to evaluate the cells in an additional six patients in earlier stages of the disease, and therefore most likely to benefit from a timely neural stem cell transplant. However, no eligible patients have been identified or enrolled despite diligent efforts by the clinical investigators over the past six months. Out of 22 initial prospects, not one patient has met the entry criteria for the trial. Researchers said this highlights the significant challenges the company would face in completing, within a reasonable period of time, the much larger studies in the target patient population that would ultimately be required for marketing approval.

Durham, North Carolina-based Aldagen has withdrawn its long-awaited $80.5 million IPO, the Triangle Business Journal reported. In pulling its offering, the drug developer cited market conditions for its decision. Aldagen filed to go public in October 2009 to raise as much as $80.5 million. It was the second time the company sought to go public. In May 2008, Aldagen filed a registration statement with regulators only to withdraw it five months later.

The U.S. Food and Drug Administration rejected Merck's request to expand the use of its cervical cancer vaccine Gardasil for women between the ages of 27 to 45, Reuters reported. Merck said that the agency found Gardasil has not been shown to prevent HPV-related cervical cancers in women over the age of 26 and the drug's label has been updated to reflect that decision. The vaccine is approved for use in females age 9 through 26 for prevention of cervical, vulvar, vaginal and anal cancers.

Ambrilia said that its directors have approved resolutions to ask a Canadian Superior Court to terminate protection granted by the court under the Companies’ Creditors Arrangement Act so it could file for bankruptcy. Following passage of the resolution all the directors of Ambrilia resigned. Ambrilia has been operating under the protection of the Companies’ Creditors Arrangement Act since July 31, 2009. The Toronto Stock Exchange delisted the common shares of Ambrilia at the close of market on March 4, 2011 for failure to meet the continued listing requirements of the TSX. The biotechnology company is focused on the discovery and development of novel treatments for viral diseases and cancer.

Capstone Therapeutics said it is delaying the reporting on 12-month results from a mid-stage treatment for surgical scarring because of the size and complexity of the dataset. The company originally expected to report the data at the end of the first quarter of 2011. It now says it will report the data as soon as practicable.


April 08, 2011
http://www.burrillreport.com/article-stemcell_discontinues_batten_disease_trial_for_lack_of_enrollment.html