Tuesday, May 10, 2022

FDA Grants Fast Track Designation to VB-111 for Platinum-Resistant Ovarian Cancer

This is excerpted from an article in OncLive by Chris Ryan April 22, 2022
The FDA has granted a fast track designation to VB-111 (ofranergene obadenovec), a targeted anticancer viral gene therapy, for use as a potential therapeutic option in patients with platinum-resistant ovarian cancer.
    VB-111 is designed to use a dual mechanism to target a wide range of solid tumors, including ovarian cancer. The mechanism pairs the blockade of tumor vasculature with an antitumor immune response. Prior data from a phase 1/2 trial (NCT01711970) indicated that when VB-111 was combined with paclitaxel in this patient population, it was efficacious and safe.
    Among the 21 patients enrolled to the trial, approximately half had platinum-refractory disease and half previously received treatment with antiangiogenics....
The combination is currently under further exploration in the phase 3 OVAL trial (NCT03398655), where it is being compared with paclitaxel alone in patients with recurrent platinum-resistant ovarian cancer.
    “We are pleased to receive FDA fast track designation for [VB-111] in platinum-resistant ovarian cancer. The fast track designation can facilitate the process toward potential registration and, importantly, may help expedite the time to market for [VB-111], if approved,” Dror Harats, MD, chief executive officer of VBL Therapeutics, stated in a press release. “The readout of the PFS primary end point in the OVAL trial will be an important milestone for VBL in the second half of [2022]. We believe that, if positive, this will support a biologics license application submission to the FDA.”
OVAL recently completely enrollment of 409 patients, and the trial is being conducted at cancer centers throughout the United States, Europe, Israel, and Japan. 

Friday, May 6, 2022

2022 TTT Retreat Applications/Forms


This year our annual Turning the Tide Ovarian Cancer Retreat will be held at beautiful, Essex Woods Meeting and Retreat Center, in Essex, MA.

The links are available at the bottom of the screen for you to download the application instructions, the application itself, the health history form and the consent form. You can print it out and send it back to me via email or mail. If you have trouble opening the link or you are without the ability to print, please contact me at mastrangelom@comcast.net so that I can send you a hard copy.

The acceptance process is not first-come, first-serve. Please make sure that if you are mailing the hard copy of your forms, it must be received by Tuesday, May 24th so that we can contact you by Friday, May 27th by email or 'phone to confirm your spot. We will have a wait list available.

Do not send any payment at this time - please wait until your spot has been confirmed.

·      Again, only after you have been notified of your spot, please send your check for $250 (or any amount – we want all women to attend regardless of ability to pay) payable to: Turning the Tide Ovarian Cancer Retreats Inc.

 NOTE: If you need to request a scholarship (assistance for payment) please check the box on the application form.

We so look forward to your application! 

Here are the links to each document:

Application Instruction

Application

Health Form

Consent Form