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Preliminary files still available - since locally stored

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read_this_n0w Member Level  Tuesday, 02/16/10 01:57:30 PM
Re: read_this_n0w post# 90665
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Preliminary files still available - since locally stored




ALS results IPLEX in small group of USA patients
Update by US patient group, relates to IPLEX made by Insmed - INSM (nasdaq)


We are pleased to present the Interim Report of the Investigational New Drug trial on the use of Iplex (mecasermin rinfabate) by middle-to-late stage Amyotrophic Lateral Sclerosis patients. This trial was conducted under the direction of Principal Investigator Michael E. Schafer, MD and Medical Director of ALS WORLDWIDE, with our assistance. We are hopeful the results will be informative and will serve to facilitate the future use of Iplex for others within the ALS community. While this is a small study, it has provided relevant results for the period from April 2009 through November 2009. For more detailed information, please review the information at the following links.

During the 30-week period of Iplex usage that comprised the first half (26 week study peeriod and follow-up four-week confirmation period) of the one year authorized investigational new drug trial, there was a remarkable parity between the apparent responsiveness of the individual patients compared to the aggregated group of patients at large. Symptoms monitored for their absence, presence, or their degree of severity included the following: Hyperreflexia; Tongue Movement; Swallow; Hand Strength; Shoulder Strength; Fatigue; Clonus; Nausea; Atrophy; Breathing; Lability; Lower Arm Strength; Fasciculations; Dizziness; Cramps/Pain; Weakness; Balance; Speech; Upper Arm Strength; Tremor/Palsy; Rigidity; Libido. In the consolidated 30 week period, individual symptoms showed a maximum decline of 9% (Balance) followed by 6% (Tremor/Palsy). The maximum improvement of an individual symptom was 39% (Fasciculations) followed by 28% (Fatigue). The critical function (Swallowing) improved by 25% and Breathing improved by 1%.

Compared to the normal relentless worsening in virtually all symptoms over any continuous 30-week period of time, the use of Iplex appears to have stabilized, if not improved, the condition of its users. Those using Iplex demonstrated an average improvement of symptoms of 9.3% (all symptoms combined) after the 30-week period.

There were no adverse events or serious adverse events during the 26-week study period. During the fourt week confirmation period, two serious adverse events occurred: one death from apparent unrelated to Iplex usage in week 28 and one death from apparent unrelated to Iplex usage in week 30.

In line with earlier Italian results


Dr. Schafer (lead investigator for USA patients) CV
From ALS Worldwide:

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