AVAX Technologies Announces Results Of Its OVAX, Ovarian Cancer Vaccine, Phase 1/2 Clinical Trial In Patients With Relapsed Stage III Or IV Ovarian Cancer
Philadelphia, PA, January 22, 2016 – AVAX Technologies, Inc. (USOTC: AVXT), a pioneer in personalized cancer vaccines, today announced the results of its Phase 1/2 OVAX study in patients with platinum resistant relapsed Stage III or IV Ovarian Cancer. The overall design is a Phase I/II, double-blind, three-dose regimen, multi-centered, trial in patients with stage III or stage IV ovarian carcinoma who have undergone de-bulking followed by intra-peritoneal chemotherapy.
Study Endpoints were treatment-emergent and related adverse events, serious adverse events, and grade 3 and 4 laboratory abnormalities for safety assessment, DTH responses to DNP-modified and unmodified autologous ovarian cancer cells. Other measured parameters were CA-125 levels and survival.
A total of 34 patients were enrolled in the study out of which 2 were lost to follow-up. 34 patients were treated at 3 doses. 12/34 are alive with 8 more than 3 years and median survival is 22.7 months. No treatment-related Serious Adverse Events have been observed.
AVAX’s management continues to be very encouraged and optimistic about the prospects of its personalized autologous cancer vaccine platform. “This study indicates that OVAX can be safely administered to patients with advanced ovarian cancer,” commented Dr. David Berd, Chief Medical Officer of AVAX Technologies. “We are also encouraged by the survival results, which appear promising in this group of very advanced ovarian cancer patients whose tumors were resistant to standard chemotherapy.”
Ovarian cancer is the eighth most common cancer among women and is the fifth leading cause of cancer related deaths in women. It is estimated that there will be 22,240 new cases of ovarian cancer in the U.S. in 2013 and 14,000 cancer related deaths.
About AVAX Technologies Inc. (USOTC:AVXT)
AVAX Technologies, Inc. is a pioneer in cancer vaccine development. Although subject to the same FDA regulations as other biological products, vaccines are inherently more difficult to develop, characterize, and manufacture than most pharmaceutical products. Vaccine development and commercialization is a long complex process. Avax is a leader in terms of stage of development and commercial readiness in the immuno-oncology arena. Today, the GMP approved facility is in Philadelphia and represents one of the very few autologous vaccine approved production facilities in the world.
AVAX’s core technology platform, termed, Autologous Cell (“AC”) Vaccine Technology is a universal platform approach to individualized cancer vaccine therapy. AVAX has 2 vaccines that have completed phase 2 clinical trials, both designated with Orphan Drug Status. MVAX is a post-surgical autologous cell vaccine for melanoma, which was approved to enter a Phase III-REGISTRATION trial for the treatment of Stage 4 melanoma patients with measurable metastasis. OVAX is AVAX’s post-surgical autologous cell vaccine for Stage 3 & 4 ovarian cancer. The OVAX trial is a phase I/II trial that has completed enrollment and is in the process of gathering follow-up data on all patients. This data will be submitted to FDA when complete and will be used to file an application in support of a follow-on phase II or phase III trial. In addition, the Company’s pipeline includes a second generation autologous vaccine, developed by the inventor of MVAX and OVAX. Finally, the Company has an extensive bio-bank of lymphocytes and tumor cells from AC Vaccine-treated patients that may be of commercial interest as a key to identifying new human cancer antigens.
Further information about AVAX can be found on the Company website (www.avax-tech.com), 2000 Hamilton St., Suite #204, Philadelphia, Pennsylvania 19130, Telephone: 215-241-9760: or Adele Sommerfeld, CEO,email@example.com.
Statements made in this news release contain forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using OVAX and MVAX and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, that are not historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, and regulatory or clinical results or practices. More specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trial process, uncertainties about the timely performance of third parties, and risks related to whether the Company’s products will demonstrate safety and efficacy. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve significant risks and uncertainties, including those discussed herein and more fully described in the Securities and Exchange Commission (SEC) reports filed by AVAX.
Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. Clinical and commercial development for existing product candidates cannot be guaranteed and movement from the clinic phase to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new product will be successful and become a commercial product. The length of time that it takes to complete clinical trials and obtain regulatory approval for product marketing varies. We cannot guarantee that we will be able to produce commercially successful product. You should not place undue reliance on any forward-looking statements. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our product candidates. The Company assumes no obligation to update any forward-looking statements, as a result of new information, future events or developments, except as required by securities laws.