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study - reinforces positive phase ii results
PRANA’S OPEN LABEL EXTENSION STUDY OF PBT-1
REINFORCES POSITIVE PHASE II RESULTS
PBT-1 Slows Alzheimer’s Disease Progression and Well Tolerated by Patients
Melbourne, Australia –October 12, 2004: Prana Biotechnology Limited (NASDAQ:
PRAN, ASX: PBT), today announced the results of the open label 84-week “Extension
Study” of its Phase II clinical trial of PBT-1 (clioquinol) study, also known as the CQAD study.
The data from the formal treatment phase of the study was published in the December 2003
issue of Archives of Neurology.
All participants from the original 36-week blinded and placebo-controlled portion of the Phase
II trial were offered the opportunity to continue the PBT-1 treatment on an open label basis for
an additional 48 weeks. 18 (66.7%) out of 27 patients elected to start the CQADEX
extension study. Nine patients completed the full 84-week study.
“The Extension Study data demonstrates that PBT-1 treatment for Alzheimer’s appears to
slow the expected disease progression by about half,” said Jon Alsenas, DVM, chief
executive officer of Prana Biotechnology Limited. “The rate of decline in PBT-1 treated
patients, compared to the predicted rate of decline, suggests that the drug has a diseasemodifying
treatment effect, not simply a cognition enhancement effect. Moreover, the results
show that PBT-1 is well tolerated by patients and has no increased adverse effects over
those to be expected in untreated patients suffering from Alzheimer’s disease.”
Data from the Extension Study data revealed that Alzheimer’s patients with ADAS-cog scores
similar to those in the CQAD and the CQADEX would have been expected to decline by an
average of 18 points over the treatment period. The results showed an average decline of
approximately eight points for a difference of 10 points from that predicted without treatment
in the nine patients on PBT-1 for 84 weeks. Results from the MMSE (Mini Mental State
Examination) were also encouraging, as, when compared to baseline, the patients on 84
weeks of PBT-1 demonstrated no statistically significant decline.
"PBT-1 represents a novel approach to Alzheimer's: namely, a disease-modifier. In other
words, PBT-1 targets a key feature of the underlying process that appears to cause the
destruction of nerve cells,” said Sam Gandy, MD, PhD, Professor of Neurology and Director
of the Farber Institute at Thomas Jefferson University. “Alzheimer's is believed to begin as
long as 10 years or more before clinical memory loss is manifested. Accordingly, diseasemodifying
drugs may need to be administered for many years. Along this line, it is extremely
encouraging to see evidence that PBT-1 is well-tolerated for extended periods.”
The full publication on the data from the extension study is available on Prana’s website
www.pranabio.com.
Prana is currently evaluating the next potential steps in continued PBT-1 clinical development
and anticipates being able to announce its plans in the near future.
Company Management is hosting an Analyst Day at The Four Seasons, Salon A&B, in New
York City, on Monday, October 18, 2004. Featured speakers will include Dr. Bush, Professor
Rudolph Tanzi, Neurology, Harvard Medical School, Massachusetts General Hospital, Dr.
Craig William Ritchie, Psychiatry, Royal Free Campus, University College London, UK and
Medical Director, Clinical Trials Centre, UCL Biomedica, University College London, UK, as
well as Dr. Jon Alsenas CEO and Dr. Ross Murdoch, COO of Prana.
About Prana Biotechnology Limited
Prana Biotechnology was established to commercialize research into Alzheimer's disease
and other major age-related degenerative disorders. The company was incorporated in 1997
and listed on the Australian Stock Exchange in March 2000 and listed on NASDAQ in
September 2002. Researchers at prominent international institutions including the University
of Melbourne and Massachusetts General Hospital, a teaching hospital of Harvard Medical
School, discovered Prana’s technology.
This press release contains “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995
regarding the Company’s business strategy and future plans of operation. Forward-looking statements involve known and unknown risks
and uncertainties; both general and specific to the matters discussed in this press release. These and other important factors, including
those mentioned in various Securities and Exchange Commission filings made by the Company, may cause the Company’s actual results
and performance to differ materially from the future results and performance expressed in or implied by such forward-looking statements.
The forward-looking statements contained in this press release speak only as of the date hereof and the Company expressly disclaims any
obligation to provide public updates, revisions or amendments to any forward-looking statements made herein to reflect changes in the
Company’s expectations or future events.
For further information, please visit our web site at www.pranabio.com.
Contacts:
Jon Alsenas, CEO, Prana Biotechnology Ltd.
1-203-328-3097
Ivette Almeida, Media Relations
1-212-983-1702 ext. 209
Rachel Levine, Investor Relations
1-212-983-1702 ext. 207
Amy Winter, Media Australia
02 9293 2939