Navigation Links
Phase II Trial Shows Favorable Response for Patients Receiving Combination Therapy With SurVaxM
Date:6/2/2019

With their phase II study in patients with aggressive brain cancer now completed, the developers of the cancer immunotherapy SurVaxM are sharing research results at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO), reporting that combination therapy with the vaccine was more effective than standard therapy for nearly all patients. The meeting, which continues through June 4 at McCormick Place in Chicago, Illinois, is the largest clinical cancer research meeting in the world.

SurVaxM was developed at Roswell Park Comprehensive Cancer Center by Robert Fenstermaker, MD, Chair of Neurosurgery, and Michael Ciesielski, PhD, Assistant Professor of Neurosurgery. The vaccine is a new and unique cancer immunotherapy designed to stimulate a multifaceted immune response targeting survivin, a tumor-survival antigen not generally present in nonmalignant cells.

In this five-center, single-arm phase II clinical trial (NCT identifier no. 024455557), 63 patients with newly diagnosed glioblastoma (nGBM), median age 60, were followed for safety, six-month progression-free survival, 12-month overall survival and immunologic response. All patients underwent standard treatment, involving craniotomy, radiation and treatment with temozolomide both before and after surgery. Immune response was assessed by detection of a survivin-specific antibody and CD8+ T-cell levels.

The team reports that, compared to a historical analysis of patients receiving standard therapy alone, combination therapy with SurVaxM generated encouraging efficacy and immunogenicity in patients with newly diagnosed glioblastoma, with minimal toxicity or side effects. The vast majority of patients — 96.8% — did not experience disease progression within six months of treatment, and 93.5% were alive a year after diagnosis, compared to expected 65% survival based on historical comparisons.

“We saw significant increase in both progression-free and overall survival, which is noteworthy in patients with such a notoriously aggressive and treatment-resistant disease,” says Dr. Fenstermaker, senior author on the study.

“We were especially pleased to see that even patients with poor prognostic factors like high levels of survivin responded well to this combination of standard therapy plus SurVaxM,” adds Dr. Ciesielski, who will present these findings in a poster presentation during the ASCO Annual Meeting.

The results will also be highlighted in a poster discussion by first author Manmeet Ahluwalia, MD, Miller Family Endowed Chair in NeuroOncology at Cleveland Clinic. Researchers from Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute/Harvard Medical School and Massachusetts General Hospital also contributed to this research.

Glioblastoma is the most common form of brain cancer in adults, and also the most aggressive. Median survival for patients treated with standard therapy is 14.7 months.

SurVaxM was awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) in 2017. New studies incorporating SurVaxM are expected to open at both Cleveland Clinic and Roswell Park in the coming months.

Drs. Fenstermaker and Ciesielski gratefully acknowledge donations to Roswell Park in support of their work.

Dr. Ciesielski will also give an invited presentation about SurVaxM June 3 during the 2019 BIO International Convention in Philadelphia (session ID 537706) on behalf of MimiVax LLC, an early-phase Roswell Park spinoff company formed to develop the vaccine. Drs. Ciesielski and Fenstermaker are co-founders and equity shareholders in MimiVax.

ASCO 2019 Presentation Details:

SurVaxM with standard therapy in newly diagnosed glioblastoma: Phase II trial update

Abstract 2016

Poster presentation:
Presenting author: Michael Ciesielski, PhD, Roswell Park Comprehensive Cancer Center
Time/date: Sunday, June 2, from 8 a.m. to 11 a.m. CDT
Location: Hall A
Session: Central Nervous System Tumors
Poster board: 205
Poster discussion session:
Presenting author: Manmeet Ahluwalia, MD, Taussig Center Institute, Cleveland Clinic
Time/date: Sunday, June 2, from 4:30 p.m. to 6 p.m. CDT
Location: Room S404
Session: Central Nervous System Tumors

This release is also available on the Roswell Park website: https://www.roswellpark.org/media/news/phase-ii-trial-shows-favorable-response-patients-receiving-combination-therapy-survaxm

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at http://www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

Read the full story at https://www.prweb.com/releases/phase_ii_trial_shows_favorable_response_for_patients_receiving_combination_therapy_with_survaxm/prweb16351073.htm.


'/>"/>
Source: PRWeb
Copyright©2019 Vocus, Inc.
All rights reserved


Related medicine technology :

1. Nortis Awarded $688K NIH Phase II SBIR Fast Track Grant to Develop Living Model of Human Blood-Brain Barrier
2. CerSci Therapeutics Awarded Phase II SBIR Grant from the National Institute on Drug Abuse of the National Institutes of Health
3. Oramed Announces End-of-Phase 2 Meeting with FDA to Initiate Phase 3 Program
4. IDF, in partnership with Lilly, announces second phase of BRIDGES programme funding for translational research in diabetes with focus on secondary prevention
5. Novavax RSV F Vaccine Phase 2 Clinical Trial Data in Women of Child Bearing Age Published in Vaccine
6. Lilly Builds Upon Body of Data for Abemaciclib with Phase 3 MONARCH 2 Data Demonstrating Superior Progression-Free Survival in Advanced Breast Cancer
7. Abide Therapeutics Announces Dosing of First Patient In Phase 1b Study of ABX-1431 in Tourette Syndrome and Collaboration with Tourette Association of America
8. CASI Pharmaceuticals Reports On Enrollment Status Of ENMD-2076 Phase 2 Study In Triple-Negative Breast Cancer
9. Rebiotix Reports Positive Top Line Data from Open-Label Phase 2 Trial of RBX2660 in Recurrent Clostridium difficile
10. Medivir Announces Positive Data From the Phase II Study of Remetinostat in Patients With Early-stage Cutaneous T-cell Lymphoma
11. MGB Biopharma Closes $1 million Financing Round to Finance Manufacturing of MGB-BP-3 for Phase II Study in Clostridium difficile-Associated Disease (CDAD)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2019)... ... September 17, 2019 , ... Today, in partnership with ... contraception and consent with student and faculty from The City University of New ... Francisco Ramirez, MPH; Elise Schuster, MPH; Raffaele M. Bernardo, DO, FACP, AAHIVS and ...
(Date:9/17/2019)... ... September 17, 2019 , ... Embr Labs , the ... Series B funding led by DigiTx Partners, with participation from Safar Partners, ... use the investment to grow the company’s footprint in wellness and digital therapeutics, accelerate ...
(Date:9/17/2019)... ... September 17, 2019 , ... Gustavo Grodnitzky, PhD will join the ... Yoga Science as holistic mind/body medicine for physicians and other health care professionals. Entitled ... 22-26, 2019 at the Cranwell Resort and Spa in Lenox, Massachusetts, is accredited by ...
Breaking Medicine Technology:
(Date:9/11/2019)... ... 2019 , ... Global Education Group (Global), a division of ... the official accreditor for PAINWeek, the largest US pain conference for frontline practitioners. ... has done for the past ten years. In addition, the Global team introduced ...
(Date:9/11/2019)... ... September 11, 2019 , ... GRM Information Management, ... Health Data and Information Conference in Chicago, Illinois September 14 to 18. ... more about GRM’s healthcare information management solutions . , Built around their ...
(Date:9/11/2019)... ... September 11, 2019 , ... Autopsies don’t lie. They report the causes ... , Methamphetamine permanently harms the heart. It increases risks of heart attack and ... of how the damage occurs. , An August 1, 2019 article in ...
(Date:9/11/2019)... ... September 11, 2019 , ... Ahipoki is excited to ... poke bowl option appeals to vegans, vegetarians, pescatarians and poke bowl fans alike. ... sesame oil. With its meaty texture similar to tuna, Ahipoki customers ...
(Date:9/11/2019)... ... September 10, 2019 , ... Women’s Excellence is excited to announce ... at 32686 Woodward Ave, Suite 103, Royal Oak, MI 48073 in the heart of ... offers comprehensive women’s health services in a contemporary, spa-like atmosphere. We are thrilled ...
Breaking Medicine News(10 mins):