news careers Patient and Caregiver Resources Aravive was founded with the mission to develop novel, targeted therapeutics to improve the health and extend the lives of patients with cancer. Aravive Clinical Trials Aravive is currently conducting clinical trials of its lead compound, batiraxcept (formerly AVB-500), in combination with standard anticancer treatments in multiple indications. For information on our AXLerate Phase 3 trial in platinum-resistant ovarian cancer, please visit www.clinicaltrials.gov or https://ovariancancertrial.com/en-us. For information on our Phase 1b/2 trial in renal cell carcinoma, please visit the study page at www.clinicaltrials.gov. For information on our Phase 1b/2 trial in pancreatic adenocarcinoma, please visit the study page at www.clinicaltrials.gov. Expanded Access Aravive, Inc. Expanded Access Policy Aravive, Inc. is a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer. The following is Aravive’s policy for evaluating and responding to requests for individual patient access to its investigational drugs that are intended to treat serious diseases. Aravive believes that investigational drugs should be studied in patients as part of clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product and subsequent wider accessibility to patients. We encourage patients to speak with their physicians and to participate in clinical trials. In rare cases when patients with serious diseases are unable to participate in clinical trials and have exhausted all available therapies, Aravive may consider providing an investigational drug outside of a clinical trial. General Criteria We consider several factors when determining whether to support expanded access for a given investigational drug: Will the potential benefit potentially outweigh the collective potential risks to the patient? Is there adequate drug supply for both the clinical development program (current and future trials) and broad expanded access? Is there enough evidence to reasonably assess that the drug will be safe and effective so that it can be provided to patients under expanded access in an environment that is less controlled than a sponsored clinical trial? To meet regulatory requirements, will the safety data be adequately provided to Aravive by a local physician outside of a sponsored clinical trial? Is there a good understanding of the indication for which use is requested? Will it jeopardize the ongoing development work that Aravive is conducting to bring a therapeutic to market as quickly as possible and to as many patients as possible? In addition, the program must be compliant with local rules and laws and the treating physician must be willing to open a single-patient (Investigator) IND with the FDA. Contact Information A treating physician may submit questions or requests regarding expanded access to the following: clinicaltrials@aravive.com Additional information may be obtained from the U.S. Food and Drug Administration at https://www.fda.gov/downloads/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm504494.pdf Request Procedures Requests should be submitted to clinicaltrials@aravive.com by the treating licensed physician and should include sufficient supporting detail to enable Aravive to evaluate the expanded access request. Please include contact information so Aravive can follow-up with the physician directly (i.e., address, phone number, e-mail). The requesting physician would be expected to submit an Investigator IND, if appropriate, only after Aravive review of the provided information and approval of the request. Anticipated Timing Aravive will endeavor to acknowledge receipt of any expanded access questions or requests within 5-10 business days of receipt. Aravive may revise this expanded access policy at any time. Additionally, the posting of the policy by Aravive shall not serve as a guarantee of access to any specific investigational drug for any patient. Patient & Caregiver Resources Cancer is a difficult diagnosis for patients and their families. Below are some resources that may be useful for those seeking information about ovarian and other cancers and help in navigating the emotional and other issues affecting patients and caregivers dealing with a cancer diagnosis. Foundation for Women’s Cancer The Foundation for Women’s Cancer (FWC) steadily pursues its mission of supporting research, education, and public awareness of gynecologic cancers. The FWC is the official foundation of the Society of Gynecologic Oncology (SGO), the premier medical specialty society for health care professionals trained in the comprehensive management of gynecologic cancers. National Ovarian Cancer Coalition Committed to raising awareness of ovarian cancer in communities across the country and to providing education, support, and hope for women with ovarian cancer and for their families. The Clearity Foundation Helping women with ovarian cancer understand their treatment options, determine what is best for their particular disease and providing online support. CancerCare Providing free, professional support services and information to help people manage the emotional, practical, and financial challenges of cancer. Cancer.net Doctor-approved patient information from American Society of Clinical Oncology. ©2021 Aravive Terms of Use | Privacy Policy