Aravive Presents Positive Phase 1b Portion of Phase 1b/2 Study

Aravive (NASDAQ:ARAV) has announce positive data from the first 12 patients of its ongoing Phase 1b portion of its Phase 1b/2 study of AVB-500 in patients with ovarian cancer.

As quoted in the press release:

The open-label, Phase 1b portion of the study of AVB-500 in patients with platinum-resistant recurrent ovarian cancer enrolled patients into two cohorts, one investigating a combination of AVB-500 with pegylated liposomal doxorubicin (PLD) and the other, a combination with paclitaxel (PAC). In both study groups, AVB-500 treatment led to early proof of concept with overall best response rate (ORR) by investigator determined RECIST v1.1 criteria and durable response in responders. AVB-500 was well tolerated with no dose limiting toxicities (DLT). The data from the initial 12 patients are summarized as follows:

• Clinical benefit [Partial Response (PR) + Stable Disease (SD)] in 7 out of 12 patients (58 percent)
• Partial responses (PR) in 5 out of 12 patients (42 percent)
  • The mean response rate in patients treated was 50 percent with AVB-500+PAC, and 33 percent with AVB-500+PLD
  • Three responders had at least 60 percent tumor regression
  • Two responders had more than 80 percent tumor regression
• The current average treatment duration for responders is 7 months and 4 of 5 patients who responded remain on study
  • Two patients who responded have completed their chemotherapy regimen and are receiving AVB-500 alone

“Due to its aggressive nature, ovarian cancer has been particularly challenging to address therapeutically, so we are encouraged by the early positive efficacy signal,” said investigator Bradley J. Monk, M.D., professor and director of the division of gynecologic oncology at Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center in Phoenix, Arizona. “This clinical study continues to support previous literature that highlights the potential for agents that can inhibit the GAS6/AXL pathway to provide new treatment options for ovarian cancer patients.”

Click here to read the full press release.