Four trading days ago, shares of Prana Biotechnology Ltd. (PRAN) were trading a $4 each. A little jump ahead on Thursday was followed by a surge on Friday that has continued in early Monday action as hopes seem to be rising related to the company’s phase 2 clinical trial of a new drug for Alzheimer’s Disease.
The catalyst last week for the Melbourne, Australia-based company was a news story run on Yahoo’s (YHOO) Australian website stating that, “There is a breakthrough drug being trialled that could give hope to hundreds of thousands of Alzheimer’s sufferers.” The article indirectly references Prana’s oral drug, called PBT2, and the IMAGINE trial, discussing the benefits that have been observed in a 57-year-old Alzheimer’s patient named Kelvin Lawler.
Further, Prana was pegged to the article with an image of its experimental 250 mg red pill and pill bottle with the name of the drug used in the accompanying video.
According to Associate professor Steve Macfarlane, who has been overseeing the trial at Melbourne’s Caulfield Hospital as part of the global study, the preliminary response by Lawler has been “incredible.” Macfarlane noted a clear improvement in Lawler’s memory, saying Lawler is a “poster child for success in clinical trials.”
The IMAGINE trial is a 12-month, double-blind study where patients are administered PBT2 once per day and tested once per month for any effect.
Macfarlane said that the drug seems to have slowed the progression of the disease by about 30 percent in patients with mild Alzheimer’s compared to placebo.
For their part, Prana issued a statement on Friday saying that the company was not aware of the segment and did not participate in it. “The clinical benefit, if any, of PBT2 compared to a placebo will not be known until treatment assignment is un-blinded and the trial data analysed,” Prana said in the release.
On Monday, Prana followed Friday’s statement with an update on the IMAGINE trial, reporting that 29 patients of the 42 patients originally enrolled in the trial have completed treatment. After completing the year-long initial protocol, patients can opt into an open-label extension study for another year of treatment. According to Prana, 24 of the 29 patients that have completed the first round have elected to participate in the extension study. That bodes pretty well for patients apparently feeling that there is a benefit with minimal side effects.
The Data Safety and Monitoring Board has reviewed the trial for a fifth and final time, once again offering no recommendation for any changes in the study’s protocol.
The results for the phase 2 trial are expected in March 2014.
Prana is also researching PBT2 in a phase 2 trial for Huntington’s Disease. Other drugs in the pipeline for neurodegenerative diseases are still in pre-clinical development, including PBT434 for Parkinson’s Disease, which is being funded by the Michael J. Fox Foundation.
The latest appreciation in share value follows a rise that started in June around $2.10 that saw the stock price climb to a high of $6.50 in August. In Monday trading, shares of PRAN touched $6.05, but have slipped back to $5.69 a little over one hour into the session. Even with the jump in share price, Prana still only commands a market capitalization of $218 million, a valuation that most will likely deem as inexpensive should the data in March support a large-scale pivotal trial for a disease desperately in need of innovative and effective drugs to treat.
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