And the tgen response. I agree with them the Post article was a bit slanted. But the patient still died and it may be difficult for tgen to show the patient death was unrelated to tgAAC94.
Press Release Source: Targeted Genetics
Targeted Genetics Responds to Washington Post Article
Monday August 6, 1:55 pm ET
SEATTLE, WA--(MARKET WIRE)--Aug 6, 2007 -- Targeted Genetics Corporation (NasdaqCM:TGEN - News) responded to an article in today's Washington Post with respect to its development program of tgAAC94, an investigational therapy for the treatment of inflammatory arthritis. The Company believes that it is unfortunate that the article seems designed to agitate as opposed to inform. The incident central to the article currently is being assessed by the Company and the FDA, and the Company believes that it would be premature as well as irresponsible to draw any conclusions prior to the completion of that investigation.
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The Company and the FDA stopped the trial in a timely manner due to uncertainty of the cause of a serious adverse event (SAE), but as has been stated previously, there is currently insufficient information to draw conclusions as to the cause. This patient's course of illness is not consistent with the Company's previous clinical experience in the 130 patients who have received tgAAC94 to date; nor is it consistent in the more than 300 patients that have been treated in the Company's AAV clinical trials in total.
"Patient safety is of paramount importance and we have designed and conducted all of our trials with that in mind. We are confident in the safety of our product and platform and look forward to the opportunity to complete the clinical trials, which is the only way to determine the efficacy and safety profile of this or any other drug candidate," said H. Stewart Parker, president and chief executive officer of Targeted Genetics.
"All of us at Targeted Genetics are deeply saddened by the unexpected death of this patient, and while our ability to communicate around this event is limited by both patient privacy and FDA regulations, we are committed to being as transparent as possible with respect to our activities prior to the patient's death and to sharing additional information as it becomes available," added Parker.
Patient Safety Chronology of Reporting
"We shared a very detailed chronology of our analyses and reporting activities regarding this particular study patient with the reporter from the Washington Post, which demonstrated how we acted in strictest compliance with today's best clinical trial practices, and which was not included in the article," said Parker.
In February, 2007, the patient was enrolled into the clinical trial for tgAAC94, and received the first dose. The patient received a second dose of tgAAC94 on July 2nd.
On July 10th, the clinical investigator reported to Targeted Genetics that two patients had nausea, fever and vomiting. These are not uncommon events and were recorded as adverse events (AEs). The investigator advised that these adverse events were not related to study drug. Consistent with FDA regulatory procedures and the study protocol, these adverse events were noted and will be reported to the FDA in the study's annual report.
On July 13th, Targeted Genetics was notified that this patient had been hospitalized, which is considered a serious adverse event (SAE). The investigator reported at this time that the SAE was unlikely related to study drug, and the event was noted and held for submission in the annual report. The second patient's symptoms had resolved.
On July 17th, the investigator notified us that the patient's condition was deteriorating, and reiterated that the SAE was unrelated to study drug. Although this information did not trigger a reporting requirement to the FDA, the Company proactively notified the chairman of its independent data safety monitoring board, or DSMB, about the situation on July 18th.
On the 19th, the Company notified the full DSMB. After a comprehensive analysis in concert with the DSMB, due to the temporal relationship between dosing and the onset of the event, the Company decided to report the SAE to the FDA as possibly related to study drug.
Although FDA requirements are that SAEs possibly related to study drug must be reported within a week, the Company held a teleconference on July 20th with the FDA and the clinical investigator involved in this case, within 24 hours of making the determination that the SAE was possibly related to drug. The trial was officially put on hold and all study sites were notified. The official IND safety report was filed on July 23rd.
Study Safety Reported to Date
In the Phase I/II study, 127 adults have been randomized into three dose levels to receive a single intra-articular injection of either tgAAC94 or placebo into the knee, ankle, wrist, metacarpophalangeal or elbow, followed by an open-label injection of tgAAC94 after 12 to 30 weeks, depending on when arthritis symptoms in the target joint meet criteria for re-injection.
The interim data reported by our investigators at leading scientific meetings in June 2006, November 2006 and June 2007, support the safety and tolerability of single and repeat intra-articular injections of tgAAC94 to affected joints at doses up to 1x10(13) DNase Resistant Particles per milli-liter (DRP/mL) of joint fluid in subjects with and without systemic TNF-alpha antagonists. This interim data also suggest that treatment with tgAAC94 may lead to improvements in signs and symptoms of arthritis in injected joints.
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