OXiGENE Inc (NASDAQ:OXGN) has been a frustrating holding for long-term investors. A company with so much hope and promise, yet lead by a management team that has failed to deliver. However, that isn't to say that all hope is lost. Lately, signs are pointing to a turnaround that can happen, but in order to do that, shareholders need to first vote NO on a pending reverse split.
OXiGENE is a biopharmaceutical company seeking to realize the full potential of vascular targeted therapy in oncology. Vascular targeted therapy includes vascular disrupting agents, or VDAs, such as the investigational drugs that OXiGENE is developing, and anti-angiogenic agents, or AAs, a number of which are approved and widely used in oncology indications.
OXiGENE’s VDAs selectively obstruct a tumor’s blood supply without obstructing the blood supply to normal tissues, and treatment with our VDAs has been shown to lead to significant central tumor necrosis. The company believes that the treatment of cancer would be significantly improved if VDAs and AAs are used together, due to their complementary mechanisms of action. In combination, the VDA would occlude the blood vessels in the interior of a tumor while the AA would prevent the formation of new tumor blood vessels.
Last month, the FDA granted Fast Track designation to CA4P for the treatment of platinum-resistant ovarian cancer. Companies with Fast Track designation are able to benefit from more frequent meetings and communications with the FDA regarding development plans to support product registration, and may also be eligible for priority review of New Drug Applications, which shortens FDA’s standard review timeline.OXiGENE’s Fast Track application included data showing that CA4P is a novel investigational agent that has been shown in a randomized controlled trial to provide improved response rates and improved progression-free survival to patients with recurrent ovarian cancer when used in combination with bevacizumab (combination anti-vascular therapy) compared to bevacizumab alone, outcomes which were especially prominent in a subgroup of patients with platinum-resistant ovarian cancer. CEO Dr. William D. Schwieterman said:
“The FDA’s granting of Fast Track status to CA4P is a significant acknowledgement of the potential for CA4P to provide a new and better treatment option for women with platinum-resistant ovarian cancer. I am pleased that we now have the opportunity to work closely with FDA to expedite our CA4P development program in ovarian cancer, as we seek to bring this promising product candidate to patients.”
A few days before this news, OXGN announced that the European Commission had granted orphan drug designation to CA4P for the treatment of gastro-entero-pancreatic neuroendocrine tumors (NETs). The designation provides for ten years of marketing exclusivity in European Union (EU) member countries following product approval. Earlier this year OXiGENE announced that CA4P received orphan drug designation from the U.S. Food and Drug Administration for NETs, which provides for seven years of marketing exclusivity after approval.Currently trading with a market cap of $20 million, OXGN ended 2015 with $27.3 million in cash. This is enough cash to fund its protocol for FOCUS, a phase 2/3 clinical trial designed to provide the company with data to support the registration of CA4P as a new drug for the treatment of platinum-resistant ovarian cancer. We expect OXGN to enroll patients in this study before mid-year.The company's latest proxy asks shareholders to effect a reverse stock split of its common stock at a ratio in the range of 1:5 to 1:10, such ratio within that range to be determined in the discretion of the Board of Directors, and the filing of such amendment to be implemented, if at all, not later than December 2, 2016. We urge shareholders to vote NO as reverse splits always lead to wealth destruction. If you don't believe us, ask any shareholder of Great Basin Scientific Inc (NASDAQ:GBSN). We will be updating Insider Financial as soon as we know more. For continuing coverage on OXGN, sign up for our free newsletter today and get our next hot stock pick!Disclosure: We have no position in OXGN and have not been compensated for this article.







