An investment opportunity : For those interested in OxiGene (OXGN)–a developer of novel anti-cancer drugs

Disclosure

First, I own OxiGene (OXGN) stock. Also, I have two STEM degrees: chemical engineering and biological sciences, so I have some understanding of the science behind OxiGene drugs. As such, I am not an expert, but I can provide a somewhat educated evaluation.

History

OxiGene once traded at near $8,000 per share, $5,000 per share, $3,000 per share, and from $1,000 per share to the current, December 26, 2013, near $2.60 per share[6]. It is a small cap company with no current product on the market[3;7]. As such, its stock dropped over the years because of the recession and negative Earnings Per Share, EPS. What should be noted is that small-cap stocks are the usual winners of a recession recovery[4]. Also, the splits make the share price less.

Clinical Phases, Orphan Drugs, and Pipeline

With that said, Zybrestat, its leading drug, was in phase 3 for Anaplastic Thyroid Cancer (ATC)[12] and designated an orphan drug by the United States (US)[14;15], but, according to information from an OxiGene source, Zybrestat will not currently enter continued phase III trials for  ATC in the USA because of funding. As such, I assume OxiGene will not be marketing Zybrestat for ATC in the USA. Still, according to FDA website, OxiGene’s combretastatin drugs have been designated Orphan drugs for “Treatment of anaplastic thyroid cancer, medullary thyroid cancer, and stage IV papillary or follicular thyroid cancer”, “Treatment of ovarian cancer”, and “Treatment of acute myelogenous leukemia.”[16, search: combretastatin]. US Orphan drug status guarantees OxiGene exclusive marketing rights for seven years and various significant tax breaks[15]. According to the US Food and Drug Administration, Phase 3 can take from 1 to 4 years[13]. At the OxiGene website, a graphic indicates that the Zybrestat Phase 3 for ATC is half way completed, but I received a phone call from an OxiGene representative that said phase 3 for ATC will not continue in the USA due to FDA requirements for a large population of patients, near  300, in a future phase III trial. The FDA required number of subjects is, at this time, to costly for OxiGene. The representative did say that OxiGene is still planning to continue USA clinical trials for ovarian cancer. Once Zybrestat is approved by the FDA, assuming phase 3 trials continue to go well[5], a physician, oncologist as an example, can prescribe Zybrestat for other cancers, which is called “off-label” use[2], in ethical situations. In truth, I assume FDA mandates on ATC clinical trials could be an indication of future FDA mandate on ovarian cancer trials. OxiGene is also expecting early marketing of Zybrestat in the European Union, EU. Also, Zybrestat has been designated an EU orphan drug for Anaplastic Thyroid Cancer, ATC, and ovarian cancer. The OxiGene representative that contacted me also said OxiGene is still planning to market Zybrestat in the European Union once approved. Eventually, I have hope the stock will stabilize at a new price significantly greater than where I bought it.

As an example, current and past phase I thru III drug trials of OxiGene drugs, Zybrestat and OXi4503, show promise with Anaplastic Thyroid Cancer (ATC)[12], Ovarian Cancer[12], Acute Myeloid Leukemia (AML)[10;11], myelodysplastic syndrome (MDS)[10;11], and other abnormal vascular diseases such as macular degeneration[12]. Zybrestat has shown success against Pancreatic Neuroendocrine Tumor Model as well[9], and Zybrestat has had mixed results with non-small cell lung cancer[12]. This is important because investment companies look at “how many” people a drug will serve to earn profits per share. Remember, a physician can prescribe for “off-label use,” but the additional prescriptions might or might not affect the overall share price. Finally, Zybrestat has a good safety profile so far[5]. According to reference [5], Zybretsat did show some myocardial ischemia, but the OxiGene representative told me the ischemia problem has been eliminated by prescribing a drug that helps with hypertension. As the reader may know, the US FDA denies the approval of many drugs because of heart issues, but I cannot definitively say this is why the US FDA required near 300 subjects for a Zybrestat phase III trial for anaplastic thyroid cancer, ATC. As mentioned previously, an OxiGene representative told me that OxiGene will not currently be completing ATC phase 3 clinical trials in the USA because of funding.

Research Pipeline

OxIGene also has an effective research pipeline. One of OxiGene’s drugs in the research pipeline is benzosuberenes[1], which have shown success for prostate, ovarian, and non-small cell lung cancers[1] in the pico-molar range. OxiGene owns the rights to all of Baylor Universities studies on benzosuberenes. If you notice, the Division of Cancer Treatment and Diagnosis, National Cancer Institute at Frederick, National Institutes of Health, Frederick, Maryland, United States was apart of the following journal article too[1]. In truth, I do not believe the US Government wants OxiGene to fail. I believe the science behind OxiGene’s drugs is strong[1;3;5;7;8;9;10;11;12]. For a nice video of Zybrestat in action within a biologically active cancer tumor[8].

Low Stock Price

Although OxiGene has performed a reverse stock-split, which indicates a distressed company that is possibly facing NASDAQ delisting if the stock does not increase, I believe the strong science and importance of cancer therapy make the risky company a good buy. Still, I am not a financial analyst. With that said, I would ask a potential financial analyst to strongly consider the science behind OxiGene’s drugs when making a decision.

References:

[1] Tanpure, Rajendra P; George, Clinton S; Sriram, Madhavi; Strecker, Tracy E; Tidmore, Justin K; Hamel, Ernest; Charlton-Sevcik, Amanda K; Chaplin, David J; Trawick, Mary Lynn; Pinney, Kevin G. An Amino-Benzosuberene Analogue That Inhibits Tubulin Assembly and Demonstrates Remarkable Cytotoxicity, Jun 2012. Medchemcomm[online]. 2012. vol. 3(6). pp. 720-724. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3682772/ PMCID: PMC3682772; NIHMSID: NIHMS386131; doi: 10.1039/C2MD00318J

[2] Cancer.org. Off-label Drug Use: What is off-label drug use? cancer.org[online]. 2013. Available From: http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/chemotherapy/off-label-drug-use

[3] Murphy, Bryan. Yes, This Time Really is Different for OxiGENE (OXGN), Nov 6, 2013. smallcapnetwork.com[online]. 2013. Available from: http://www.smallcapnetwork.com/Yes-This-Time-Really-is-Different-for-OXiGENE-OXGN/s/via/1789/article/view/p/mid/3/id/454/

[4] Consumer Reports Money Advisor. Post-recession investing: No matter which kind of economic recovery we get, diversification still wins, Oct 2009. consumerreports.org[online]. 2013. Available from: http://www.consumerreports.org/cro/money/personal-investing/post-recession-investing/overview/index.htm

[5] Kanthou, Chryso; Tozer, Gillian M. Microtubule depolymerizing vascular disrupting agents: novel therapeutic agents for oncology and other pathologies, Jun 2009. Int J Exp Pathol[online]. 2009. vol. 90(3). pp. 284-294. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2697551/ PMCID: PMC2697551; doi: 10.1111/j.1365-2613.2009.00651.x

[6] NASDAQ. OxiGene, Inc (OXGN) Interactive Chart Analysis. nasdaq.com[online]. 2013. Available from: http://www.nasdaq.com/symbol/oxgn/interactive-chart

[7] Oxigene. Clinical Trails. oxigene.com[online]. 2013. Available from: http://www.oxigene.com/pipeline/clinical_trials/

[8] OxiGene. How Our Drugs Work. How do ZYBRESTAT (fosbretabulin) and OXI4503 work? oxigene.com[online]. 2013. Available from: http://oxigene.com/our_science/how_our_drugs_work/

[9] Wall Street Journal. OxiGene Presents Preclinical Data Demonstrating Significant Antitumor Activity of Zybrestat ® in Pancreatic Neuroendocrine Tumor Model, Oct. 21, 2013. online.wsj.com[onlne]. 2013. Available from: http://online.wsj.com/article/PR-CO-20131021-905345.html

[10] Turner, Daniel BS; Gonzalez, Andres BS; Pettiford, Leslie RN; Meacham, Amy MS; Wise, Elizabeth BS; Bosse, Raphael C BS; Chaplin, Dai PhD; Hsu, Jack W. MD; Brown, Randy A. MD; Hiemenz, John W. MD; Norkin, Maxim MD, PhD; Wingard, John R. MD; Cogle, Christopher R. MD. 1463 A Phase I Study Of The Vascular Disrupting Combretastatin, OXi4503, In Patients With Relapsed and Refractory Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), Dec 7, 2013. American Society of Hematology[online]. 2013. Available from: https://ash.confex.com/ash/2013/webprogram/Paper65534.html

[11] OxiGene. Pipeline. OXi4503 in Onocology. oxigene.com[online]. 2013. Available from: http://www.oxigene.com/pipeline/OXi4503_in_oncology/

[12] Oxigene. Pipeline. oxigene.com[online]. 2013. Available from: http://www.oxigene.com/pipeline/

[13] US Food and Drug Administration. Step 3 Clinical Research. patientnetwork.fda.gov[online]. 2013. Available from: http://www.patientnetwork.fda.gov/learn-how-drugs-devices-get-approved/drug-development-process/step-3-clinical-research

[14] Landes Bioscience. Oxigene breathes life into cancer treatments. Cancer Biology & Therapy[online]. vol 6(8). Available from: https://www.landesbioscience.com/journals/cbt/article/5015/

[15] US Food and Drug Administration. Orphan Drugs. fad.gov[online]. 2013. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM311928.pdf

[16] US Food and Drug Administration. Search Orphan Drug Designations and Approvals. accessdata.fda.gov[online]. 2013. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/

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