Navigation Links
Advaxis, Inc. phase I/II results of lovaxin C in cervical cancer study released
Date:10/10/2007

LYON, France & NORTH BRUNSWICK, N.J.--(October 10, 2007)--World Vaccine Congress: A first-in-man trial of a live Listeria vaccine was reported by Advaxis Inc. (OTCBB: ADXS - News). The Phase I/II trial was testing Lovaxin C in advanced cervical cancer patients. Lovaxin C is being developed by Advaxis as an immunotherapy that is intended to treat patients with cancers that result from human papilloma virus (HPV), including cervical cancer and head and neck cancer.

In the safety study, Advaxis reported treating fifteen patients in three dosage groups with thirty-minute 250 ml infusions of Lovaxin C at three-week intervals. Patients were observed for a total of 111 days. All patients had either advanced, recurrent, or progressive cervical cancer, and with the exception of two women, all patients were stage IVb (end stage). Every patient experienced a flu-like syndrome in the three-to-twelve hours after dosing comprised of fever, chills, nausea, and occasional vomiting, which is consistent with immune stimulation. In the lower two doses, symptoms were well tolerated and resolved with the use of over the counter analgesics and antihistamines. In the highest cohort the pattern of symptoms was the same, however more severe and dose limiting; which required that the study be stopped at that point as a dosage ceiling was defined. The endpoint of the study, safety, was met as the assessments confirmed that Lovaxin C was safe to administer intravenously, that the pattern of adverse responses observed, as previously stated above, were consistent with immune stimulation, and that, for this population of patients, a dosage ceiling was determined.

Although efficacy was not a primary endpoint anecdotal information was obtained. Patients' tumors were assessed by CT scans and any tumor changes were scored using RECIST criteria. Two patients had only a single tumor measurement, making the assessable efficacy population thirteen patients. It was observed that five patients progressed, seven patients were stable (defined by RECIST as changes in tumor sizes of under 30%), and one patient had a reduction of her tumor burden by 32%, qualifying as an objective partial response. Of the seven stable patients, three had reductions in their tumor mass subsequent to treatment. While most lesions increased in size, tumor reduction was seen in a number of lesions and two tumors disappeared completely. One patient, who was staged at IVb, had failed two prior courses of chemotherapy and one course of radiation. After treatment, she was deemed sufficiently healthy to resume chemotherapy and was removed from the trial early for this purpose. Following additional chemotherapy and surgery she is currently tumor free, with normal hematologic function, and all laboratories within normal limits.

"Our long held belief that live Listeria vaccines are safe, even in end stage cancer patients, has been confirmed by this study. We have just entered the age of safe bacterial therapies. This milestone has given us the direction for the continued development of Lovaxin C as well as future therapeutic agents," said Dr. John Rothman, VP of Clinical Development in assessing the trial data.


'/>"/>

Contact: Janet Vasquez
janet@investorrelationsgroup.com
212-825-3210
Advaxis, Inc.
Source:Eurekalert

Related medicine news :

1. FDA approves Phase 0 trial which tests experimental drugs on humans
2. SARS-Free Taiwan to Mark End Phase of Global Fight
3. S. Africa AIDS in death phase
4. Spray on contraceptive clears Phase I trial
5. Phase 3 trials of two multi-kinase inhibitors against cancer
6. Antigenics Pharmaceuticals plans for Phase III trial of its Melanoma vaccine
7. Phase II trails of new HIV vaccine to be held in South Africa
8. Phase 1 Drug Trials on Humans to Be Made Public
9. Jalgaon: Third Phase Of Culling Operations Begin
10. Lupin Gets DCGI Nod For Phase II Clinical Trials On Desoside-P
11. Cadila to Commence Phase I Clinical Trials On ZYH2
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... To deal with these feelings, many turn to unhealthy avenues, such as drug or ... Center of Marne, Michigan, has released tools for healthy coping following a traumatic event. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
(Date:6/24/2016)... Diego, CA (PRWEB) , ... June 24, 2016 , ... ... with the American Cancer Society and the Road To Recovery® program to drive cancer ... to seniors and other adults to ensure the highest quality of life and ongoing ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 Roche ... received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) ... severe sepsis or septic shock. With this clearance, Roche ... provide a fully integrated solution for sepsis risk assessment ... associated with bacterial infection and PCT levels in blood ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
(Date:6/23/2016)... Pa. , June 23, 2016 Bracket ... will launch its next generation clinical outcomes platform, Bracket eCOA ... Meeting held on June 26 – 30, 2016 in ... the first electronic Clinical Outcome Assessment product of its kind ... Booth #715. Bracket eCOA 6.0 is a flexible ...
Breaking Medicine Technology: