klmline

I have attatched a link for a patient currently enrolled in the START(stimuvax) Trial. He started the trial in August and I think you'll quickly see by going back and reading the posts on his blog how much his quality of life has improved, tumor shrinkage and reduction of symptoms. Obviously this is only one patient but nevertheless exciting. http://www.ronreyn.com/blog/

Is anyone here able to tell me if they've been able to enroll in the Stimuvax Trial yet and for how long? TIA, Klmline

www.nsclcstudy.com

I have not been able to find one member on this Site who's been enrolled in or is currently participating in the Multi-Center Phase III Randomized, Double-Blind Placebo-Controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease. When the oncologist spoke to Dr. Shepherd's(Frances Shepherd, MD, FRCPC, Principal Investigator, Medical Oncology Princess Margaret Hospital, 610 University Avenue, 5-104, Toronto, ON M5G 2M9A, Canada) assistant about enrolling patients in the trial he was first told that Princess Margaret Hospital wasn't participating in the trial and when he questioned further by referencing the Stimuvax Trial at the clinicaltrials.gov site(Canada Research Site, Toronto, Canada; Recruiting) he was then told that yes they would be running the trial but it had not begun yet. I don't know how this is possible when Dr. Shepherd works out of Princess Margaret Hospital and furthermore she is the lead investigator for the trial. Why do they currently show this trial site as recruiting if they aren't? Could someone please let me know if they have been able to enroll and if so where?

http://www.targetedtherapies.org/rdt1_3.html The Eastern Cooperative Oncology Group (ECOG) is planning a randomized phase II trial to assess the addition of the anti-vascular endothelial growth factor agent, bevacizumab (Avastin®), to L-BLP25 vaccine. It will compare the L-BLP25 vaccine plus bevacizumab to bevacizumab alone after best standard therapy for locally advanced lung cancer

http://biz.yahoo.com/prnews/070226/to345.html?.v=13 Anyone here lucky enough to get in?

The trial is now recruiting patients http://www.clinicaltrials.gov/ct/show/N ... 88?order=1 Trial has a completion date of Dec. 2008. Very odd that a multi national Phase III trial could recruit 1322 patients and be slated for completion within two years. Does anyone here know something that I don't about this trial?

Patients interested in potentially participating in the upcoming Phase 3 study of Stimuvax® should contact EMD Pharmaceuticals toll free at 866-363-4543 or visit their Web site for additional information (www.emdpharmaceuticals.com).

Great news http://www.fda.gov/bbs/topics/NEWS/2006/NEW01520.html

http://www.clinicaltrials.gov/ct/show/N ... 88?order=1

Here's the link: http://www.targetedtherapies.org/rdt1_5.html -click on the hyperlink to launch presentation Let's Review Dr. Butts presentation. Slide 16 Final Analysis The vaccine arm: 11/2005 survival data at 30.6 months, median survival milestone is reached (18 deaths=51%). Looks like a death at 46 months and another at 53 months Stage IIIB subgroup n=65 vaccine arm = 35 patients, Control arm = 30 Looks like 14 of the 35 patients (40%)in the vaccine are are still alive at 64 months.....WOW! The actual survival calculation was in fact better because survival was calculated at the start of randomization. The true baseline can be argued to be at the actual beginning of therapy!......WOW! Study might be optomized futher with repeated use of cyclophosamide!.....WOW! P value was actually .049 at end of study.....WOW! EXTRA BONUS: Stage IIIA is included in protocol, IV excluded, 3 month window on randomization. Gender balance more evenly weighted in phase III......WOW Why won't the FDA allow patients access to this Drug when it has shown in every trial to be perfectly safe with little or no side affects???????????????? Those who are suffering deserve access on a humanitarian basis.

Stimuvax® (formerly referred to as BLP25 Liposome Vaccine) – mimics the mucin MUC1, which is present on many tumors On January 26, 2006, Merck KGaA and its co-development partner Biomira Inc. announced the signing of a binding letter of intent to amend the licensing agreement for Stimuvax. The amended agreement gives Merck global development and marketing rights to the vaccine except in Canada, where the companies share rights to the vaccine. Under the letter of intent, Merck takes over full responsibility – both administrative and financial – for development and commercialization of Stimuvax, including the planned Phase III trial in NSCLC, which remains on track to start this summer. Survival results from the Phase IIB trial in Stage IIIB and IV non-small cell lung cancer (NSCLC) patients indicated a 4.4 month longer median survival for patients randomized to the Stimuvax arm (88 patients) compared to the best supportive care (BSC) arm (83 patients). The greatest benefit was observed in vaccinated patients with Stage IIIB locoregional NSCLC, which makes up approximately 25 percent of patients with this form of cancer. Median survival – reached for the vaccinated subset of Stage IIIb locoregional patients in October 2005 – was 30.6 months compared to 13.3 months observed for the same stage patients who did not receive the vaccine, a difference of 17.3 months. Though not statistically significant, the survival update provides additional clarity for statistical considerations for the planned Phase III trial.1,2

BLP25 has been taken over by Merck KgaA/EMD Pharmaceuticals under the name Stimuvax. Phase III Clinical Trial to start mid 2006. I strongly recommend anyone interested in more information or participating go the following link. http://www.blp25.net/home.jsp password: vaccine just fill in the rest ***Once you get into the website click on "View L-BLP25 Animation" and watch the video***

The Company also announced that median survival for patients with Stage IIIB locoregional non-small cell lung cancer who received BLP25 Liposome Vaccine (L-BLP25) in a phase 2b study has been determined [30.6 months compared with 13.3 months for the unvaccinated group].