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:8/18/2017)... (PRWEB) , ... August 18, ... ... d/b/a Quick International, LLC (“Quick”), a highly specialized asset-light logistics provider of ... entered into a definitive agreement to purchase Unitrans International Corporation, a division ...
(Date:8/18/2017)... NY (PRWEB) , ... August 18, 2017 , ... ... of “Vision & Hearing” campaign, advocating for active, healthy lifestyles and highlighting the ... available for individuals with hearing impairments and shares the latest innovations in hearing ...
(Date:8/18/2017)... McLean, VA (PRWEB) , ... August 18, 2017 ... ... offers asset protection services and financial consultations to communities throughout the greater DC ... Semper K9 with the goal of rescuing local animals and training them to ...
(Date:8/18/2017)... ... August 18, 2017 , ... MLM Insurance Group, a Miami ... southern Florida, is working to support the Take Stock In Children Foundation during ... families. , The Take Stock In Children Foundation (TSC) offers guidance and assistance ...
(Date:8/18/2017)... ... August 18, 2017 , ... The Golseth Agency, a Texas based insurance management ... spearheading a regional charity campaign organized to provide support to Christina Upchurch and her ... year, Christina and her children returned from out of town to find her husband ...
Breaking Medicine News(10 mins):
(Date:7/27/2017)... Services, Inc. (NYSE: WST ) today announced ... financial guidance for the full-year 2017. ... Reported net sales of $397.6 million, a record high, ... constant currency (organic) grew by 3.9%. ... in the prior-year quarter. Second-quarter 2017 adjusted diluted EPS ...
(Date:7/26/2017)... SINGAPORE , July 27, 2017  Radium Medical Aesthetics, a ... LASEMD, designed to delay aging by effectively addressing several skin conditions ... the skin to become rougher and more fragile. The skin becomes ... the unavoidable exposure to the harmful UV rays from the sun ... hyperpigmentation. ...
(Date:7/26/2017)... , July 26, 2017 The Galien ... Prix Galien USA Award Nominees. Counted ... Prix Galien Award recognizes outstanding biomedical and technology product achievement ... To qualify, each candidate must be U.S. Food ... five years and demonstrate tremendous potential to impact human health. ...
Breaking Medicine Technology: