• 2ME2

    by  • May 7, 2018 • Fiction • 0 Comments

    An essay by Lena Bisset, as provided by Chrissa Gerard
    Art by Dawn Vogel


    SUMMARY STATEMENT

    (Privileged Communication)
    North American Oncology Consortium
    Innovation and Impact Award

    Peer Review Panel: Detection, Diagnosis, and Treatment
    Meeting Date: 03/19/2019–03/21/2019

    Application Number: IIA201806233
    Application Status: New
    Principal Investigator: Jamie Minkov
    Applicant Organization: Atherton University

    Project Title: A Novel Treatment for Hormone-Based Cancer
    Proposed Funding Period: 09/01/2019–02/29/2020

    Overall Score (out of 5.0): 4.3

    Criteria Scores:

    Research Plan 4.1
    Innovation 4.0
    Impact 4.7

    SUMMARY

    In this application for an Innovation and Impact Award, the Principal Investigator (PI) presents results from animal trials indicating that 2-methoxyestradiol (2ME2), a naturally occurring compound found in pregnant humans, promotes apoptosis in cancer cells, particularly in breast, ovarian, and prostate carcinoma. Under a NAOC Career Foundation Award, the PI performed in vitro and in vivo studies, establishing the biomechanisms of cell death in malignant tumors. The treatment protocol was an IV injection of a 0.02 solution of 2ME2. The data show cancer remission in 83% of mice (breast and ovarian) and 66% of canines (prostate) with no negative side effects. The PI proposes a phase 1 clinical trial of 20 men (10 case/10 control) and 20 women (10 case/10 control) with newly diagnosed stage 3 prostate or breast cancer, with future opt in for the controls. The PI hypothesizes that 2ME2 will promote cancer cell death in hormone-based cancers and plans to establish its safety and allow for phase 2 efficacy studies.

    RESEARCH PLAN

    Scientist Reviewer 1: The PI has followed Institutional Review Board and NAOC protocols in assuring participant confidentiality and safety. The minimal case/control numbers are appropriate given the increasing number of patients diagnosed at stage 1 or 2. A plan for data sharing is in place.

    Scientist Reviewer 2: The first round of preclinical experiments used sulfamylated variants of 2ME2. These proved unstable and ineffective, and the PI has since partnered with Daofan Pharmaceuticals. Daofan scientists have worked with the PI and Atherton colleagues to refine a stable variant, which was used in the remainder of the preclinical experiments. Daofan is an international corporation capable of producing and shipping sufficient amounts of the synthesized compound.

    Consumer Reviewer: As a survivor of ovarian cancer, I appreciate the attention the PI gives to patient safety and the option for control patients to receive treatment after 6 months.

    Discussion Notes: A panel member noted that Daofan’s drug development data are not publicly available and have not been verified by an independent review board. This panel member noted that prior to Daofan’s involvement, the only stable sources of 2ME2 were from pregnant women. A scientist reviewer pointed out Daofan’s accreditation with the International Council for Medical Oversight and Pharmacovigilance. The panel member voiced concern about China’s history of bribing officials and of human rights violations. These concerns were noted.

    Art for "2ME2"

    A panel member noted that any clinical gains would be negated by an ethical breach, including the current gap in the preclinical data.

    INNOVATION

    Scientist Reviewer 1: The use of a naturally occurring compound with disease-fighting properties is highly innovative.

    Scientist Reviewer 2: The novel aspect of this potential cancer treatment is the significantly decreased risk of side effects due to mimicking a substance the (female) human body already produces.

    Consumer Reviewer: Nature provides the best treatments, and the PI is to be commended for pursuing this mode of treatment!

    Discussion Notes: A panel member noted that using compounds harvested from living creatures as disease treatment has occurred for decades, such as Premarin (1941) and bovine insulin (1922). The panel member noted the ethical problems related to this type of drug production, which would be insupportable if in fact the compound is still being sourced from pregnant women. This concern was not considered relevant by other members of the panel.

    IMPACT

    Scientist Reviewer 1: If the phase 1 trial results support the PI’s hypothesis, the implications for hormone-based and other cancers are vast.

    Scientist Reviewer 2: The PI’s entire postgraduate career has been devoted to this line of inquiry, which shows substantial promise in the treatment of advanced cancer. A successful trial could lead to a paradigm shift in the field.

    Consumer Reviewer: The application’s impact statement declares the aim to “give hope to the hopeless”–this is the most worthy goal!

    Discussion Notes: A panel member noted that any clinical gains would be negated by an ethical breach, including the current gap in the preclinical data. The panel member suggested the applicant resubmit the application with the complete dataset related to Daofan’s drug development processes. This issue was discussed, with the general consensus being that the application is sufficient as submitted.

    ADMINISTRATIVE NOTES

    Direct Costs Indirect Costs Total Costs
    $231,800.00 $272,500.00 $504,300.00

    Animal Subjects Code: 10—No vertebrate animals involved

    Human Subjects Code: 30—Award can be processed, human subjects involved, no human subjects concerns


    Lena Bisset is a research scientist and the chair of the Detection, Diagnosis, and Treatment panel. She fondly remembers when all research was performed on male mice and nobody cared what happened to them.


    Chrissa Gerard is a writer and editor based in North Carolina … for now.


    Dawn Vogel writes and edits both fiction and non-fiction. Although art is not her strongest suit, she’s happy to contribute occasional art to Mad Scientist Journal. By day, she edits reports for and manages an office of historians and archaeologists. In her alleged spare time, she runs a craft business and tries to find time for writing. She lives in Seattle with her awesome husband (and fellow author), Jeremy Zimmerman, and their herd of cats. For more of Dawn’s work visit http://historythatneverwas.com/.


    “2ME2” is © 2018 Chrissa Gerard
    Art accompanying story is © 2018 Dawn Vogel

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