in april 2007, i became a stuckholder in Amarin while attempting to trade a hopeful rebound after:
AMARIN REPORTS TOP-LINE RESULTS OF TWO PHASE III STUDIES OF MIRAXION IN HUNTINGTON’S DISEASE
Amarin Corporation plc (NASDAQ: AMRN) (“Amarin” or the "Company") today announces top-line results from its two Phase III clinical trials of Miraxion to treat Huntington’s disease (HD). The Company conducted two Phase III double-blind, placebo-controlled studies in which HD patients were randomized to receive either placebo or 2 grams (1 gram twice daily) of Miraxion daily for six months. Study data showed no statistically significant difference in either study between Miraxion and placebo with regard to the primary and secondary endpoints.
These top-line findings are inconsistent with earlier clinical trial data that showed statistical significance in a subset of HD patients with a CAG repeat length of less than or equal to 44.
The primary endpoint of the trials was a change in the Total Motor Score 4 (TMS-4) component of the Unified Huntington’s Disease Rating Scale (UHDRS). TMS-4 has been shown to be a sensitive measure of movement disorder in patients with HD. In addition, secondary endpoints included cognition and Total Functional Capacity outcomes. Miraxion was found to be safe and well-tolerated by patients.
Commenting on today’s announcement, Rick Stewart, Chief Executive Officer of Amarin, said, “We are extremely surprised and disappointed by these top-line results, and we are analyzing the data in order to better understand the full and complete data set and outcomes. We are particularly disappointed that, at this time, we are not in a position to bring any positive news to those patients who are suffering from this devastating disease and to the broader HD community.”
“Despite this setback with Miraxion to treat HD, we remain committed to developing Amarin’s substantial central nervous system (CNS) development pipeline.” commented Mr. Stewart. “We continue to evaluate the potential of Miraxion in treating CNS disorders and specifically our next steps with respect to the HD trials. We also intend to progress the development of our novel, oral formulation of apomorphine to treat the ‘off’ episodes in advanced Parkinson’s disease patients, our recently in-licensed nasal formulation of lorazepam for the out-patient treatment of emergency seizures in epilepsy patients and our proprietary combinatorial lipid pre-clinical program in CNS disorders and other indications.” concluded Mr Stewart.
Thomas Lynch, Amarin’s Chairman, added “Our commitment to neurology research and product development remains steadfast and we will continue to pursue other in-licensing opportunities while we advance our broad pipeline of products to treat CNS disorders.
then things grew worse:
06/08/2007
AMARIN RECEIVES NASDAQ NOTIFICATION RELATED TO MINIMUM BID PRICE
Amarin will be provided with 180 calendar days, or until December 3, 2007, to regain compliance.
yet hopeful:
10/10/2007
AMARIN ANNOUNCES INITIATION OF CARDIOVASCULAR DEVELOPMENT STRATEGY
Capitalizing on Known Therapeutic Benefits of Unsaturated Fatty Acids in Cardiovascular Disease
Amarin intends to commence a series of clinical trials with AMR 101 (97% pure EPA) in dyslipidemia, the first of which will commence by the end of this year. In addition, Amarin intends to commence investigation of new compounds from its existing development portfolio for the treatment of metabolic syndrome and dyslipidemia.
11/29/2007
AMARIN COMMENCES FIRST CLINICAL TRIAL IN CARDIOVASCULAR PROGRAM
Initiates Phase I Clinical Trial to Evaluate Ultra-Pure Ethyl EPA-Niacin for Treatment of Niacin- Induced Flushing
Announced that it has commenced a phase I clinical safety and efficacy trial in volunteers. The trial will evaluate the co-administration of ultra-pure ethyl EPA and niacin on niacin induced flushing. Flushing is a common side effect of niacin treatment which significantly limits patient compliance.
but then i became really stuck:
01/18/2008
AMARIN PROVIDES BUSINESS UPDATE AND ANNOUNCES IMPLEMENTATION OF REVERSE STOCK SPLIT
Shareholders approved a 1 for 10 reverse split of each of its Ordinary Shares. Following the reverse split, there are now 14,003,237 Ordinary Shares in issue.
Share price was $0.23 when it reverse split 10 to 1 to $2.30.
it was at this point i decided there was the potential for enough upside to recoup my original capital and then some, if amarin could be successful with their CARDIOVASCULAR DEVELOPMENT STRATEGY
07/22/2008
AMARIN PROCEEDING TO PHASE 3 WITH AMR101 FOR HYPERTRIGLYCERIDEMIA
AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid (Ethyl-EPA).
Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglycerides and is associated with increased levels of heart disease. It is one component of a range of lipid disorders collectively referred to as dyslipidemia. The overall dyslipidemia population in the U.S. is believed to be in excess of 100 million, with over 10 million of those diagnosed with hypertriglyceridemia.
and, a little over 10 years later, i was finally proven correct! ;)
while the journey took a few unpleasant turns, i learned a lot along the way.
thank you to all those who indulged my abridged'ness and taught me over these past 10 years, especially and assuredly, @JL.
"when the student is ready the teacher will appear"