Recent

% | $
Quotes you view appear here for quick access.

Advaxis, Inc. Message Board

  • yzzycz yzzycz May 15, 2013 7:04 PM Flag

    Where are the results?!

    where is abstract?

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • jmoore1977@bellsouth.net jmoore1977 May 15, 2013 7:12 PM Flag

      Abstract:

      Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it naturally cross presents, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe the preliminary survival data associated with ADXS11-001 administration in Lm-LLO-E7-015, a randomized P2 study being conducted in India in 110 patients with recurrent/refractory cervical cancer who have been treated previously with chemotherapy, radiotherapy or both. Methods: Patients were randomized to either 3 doses of ADXS11-001 at 1 x 109 cfu or 4 doses of ADXS11-001 at 1 x 109cfu with cisplatin chemotherapy. Naprosyn and oral promethazine were given as premedications and a course of ampicillin was given 72h after infusion. Patients received CT scans at baseline and 3, 6, 9, 12 and 18 months. The primary endpoint is overall survival. Results: As of February 2013, the trial has completed enrollment and 110 patients have received 264 doses of ADXS11-001. The percentage of patients alive at 6 months is 63% (67/107); at 9 months is 46% (49/106); at 12 months is 34% (30/87) and at 18 months is 15% (8/54). Tumor responses have been observed in both treatment arms with 6 CRs and 6 PRs; 36 additional patients had stable disease 3 months, for a disease control rate of 44% (48/110). Activity against different high risk HPV strains has been observed. Three serious adverse events and 69 mild-moderate adverse events possibly related/related to ADXS11-001 treatment have been reported in 41% (45/110) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that either resolved on their own or responded to symptomatic treatment. Conclusions: ADXS11-001 can be safely administered to patients with advanced cancer alone

      • 3 Replies to jmoore1977
      • GOG Abstract:
        Background: This is a GOG/NCI-sponsored phase II study (NCT01266460, GOG 0265) of ADXS11-001 in patients with persistent or recurrent cancer of the cervix. ADXS11-001 is a live attenuated Listeria monocytogenes (Lm) immunotherapy bioengineered to secret a HPV-E7 fusion protein targeting HPV-E7 transformed cells. A previous phase I dose escalation study determined the safety of ADXS11-001 in patients with late stage cervical cancer (Maciag PA. Vaccine. 2009 Jun 18;27(30):3975-83). The primary objectives of this study are to evaluate the tolerability and safety of ADXS11-001, and to assess the activity of ADXS11-001 in patients with persistent or recurrent cancer of the cervix. Secondary objectives are progression-free survival, overall survival and objective tumor response. Methods: Patient eligibility criteria: Females age ≥ 18 years with persistent or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to curative therapy). Patients must have measurable disease as defined by RECIST 1.1; at least one “target lesion” as defined by RECIST 1.1; have had one prior systemic chemotherapeutic regimen for management of their disease; have adequate organ function and must be free of active infection and not on antibiotics. This protocol is a 2-stage design with 12-month survival as the primary endpoint and with a planned sample size of up to 67 patients. Patients will receive ADXS11-001 at a dose of 1x109 CFU on Day 1 and repeat every 28 days for 3 total doses in the absence of disease progression or unacceptable toxicity, with each dose followed at 72 hours by a 7 day course of ampicillin, 500 mg QID. Tumor tissue and serum samples may be collected periodically for translational research. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. As of January 31, 2013, enrollment has been completed

      • When searching # 5529 notice there are 29 different topics pertaining to this 1 abstract.

      • In english, for us without a phd, does it really say anything we already dont know?

    • On the ASCO site, silly.

      But no India update until the meeting, it seems.

      "Results: As of February 2013, the trial has completed enrollment and 110 patients have received 264 doses of ADXS11-001. The percentage of patients alive at 6 months is 63% (67/107); at 9 months is 46% (49/106); at 12 months is 34% (30/87) and at 18 months is 15% (8/54). Tumor responses have been observed in both treatment arms with 6 CRs and 6 PRs; 36 additional patients had stable disease 3 months, for a disease control rate of 44% (48/110). Activity against different high risk HPV strains has been observed. Three serious adverse events and 69 mild-moderate adverse events possibly related/related to ADXS11-001 treatment have been reported in 41% (45/110) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that either resolved on their own or responded to symptomatic treatment. Conclusions: ADXS11-001 can be safely administered to patients with advanced cancer alone and in combination with chemotherapy. ADXS11-001 is well tolerated and presents a predictable and manageable safety profile. Final 12-month OS, updated safety and translational analyses will be presented at the meeting."

      And so the waiting continues.

      Sentiment: Buy

    • I have not found anything yet. Anybody!!!!!

      Sentiment: Hold

 
ADXS
11.81-0.02(-0.17%)Aug 29 4:00 PMEDT