Cantrixil (TRX-E-002-1)

Cantrixil is a first-in-class development candidate which targets the entire spectrum of cancer cells, including tumour-initiating cells thought to cause cancer recurrence. Cantrixil is currently being developed for treatment of ovarian cancer and an IND has been approved for Phase 1 clinical trials.

  • Market Need

    Cantrixil has international patent protection and is well-placed to achieve significant market value if clinical development is successful.

    Cantrixil has the potential to revive the use of intra-peritoneal (IP) chemotherapy as a mode of administration for ovarian cancer patients. It has the opportunity to become a standard front-line agent possibly used in combination with standard of care for a group of gynecological cancers if it can successfully reduce the rate of relapse or prolong survival.

    The Global market for ovarian cancer therapies and is around US$ 500M, projected to grow to US$ 1B over next 5 years (Decision Resources).

    Cantrixil may provide a new treatment option for women with later-stage ovarian cancer, who received limited benefit from existing chemotherapy. The survival rate for this disease is poor because of the high rate of relapse after standard-of-care treatment and the late stage at which the disease tends to be diagnosed. When ovarian cancer relapses the disease is often not responsive to standard chemotherapy agents.

    Depending on Clinical trial results, Cantrixil could prolong survival rates for women with ovarian cancer (or other related gynecological cancers such as Fallopian tube or primary peritoneal cancer) by targeting chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse.

    • Ovarian cancer is the 17th most common cancer, with ~250,000 cases pa
    • Most women are diagnosed with late-stage disease (stage III & IV), for which the prognosis remains poor
    • The front-line platinum and taxane-based treatment of this disease has not changed significantly in two decades and there is a high incidence of recurrent drug-resistant disease after chemotherapy
    • Targeted therapies for recurrent ovarian cancer have yielded mixed success due to the heterogeneous nature of the disease.

    The Science Behind It

    Cantrixil consists of the active molecule,
    a superbenzopyran named TRXE-002-01,
    encapsulated in a cyclodextrin.

    Cantrixil is a first-in-class development candidate which targets the entire spectrum of cancer cells, including tumour-initiating cells cells thought to cause cancer recurrence.

    Cantrixil is Novogen’s lead development candidate in the "Superbenzopyran or SBP" family of molecules. The novelty of this agent is its ability to kill the cancer stem cell / tumor-initiating cells and their daughter cancel cells that are responsible for cancers originating, metastasizing and relapsing. These slower-growing tumour-initiating cells are often resistant to other types of chemotherapies. Cantrixil has the potential to revive the use of intra-peritoneal (IP) chemotherapy and invigorate the use of this mode of administration for ovarian cancer patients. It has the opportunity to become a standard front-line agent, complementing the use of platinum therapy for a group of gynecological cancer. Cantrixil is currently being progressed to stage 1 clinical trials and is Novogen’s lead development candidate. A formal, good laboratory practice (GLP)-compliant toxicology program has shown Cantrixil is likely to be safe at therapeutic doses in humans.



    Timing and Market Implications

    Cantrixil is the first super-benzopyran to be developed.

    Cantrixil has been successfully taken into an international phase I clinical trial under a US IND, only three years after discovery.

    It is being studied as an IP agent for the treatment of ovarian cancer. Preclinical test data has shown broad-based evidence of anti-tumour activity in animal models of ovarian cancer.

    An Investigational New Drug (IND) application was submitted in August 2016 to the United States Food and Drug Administration (FDA) for Cantrixil (TRX-E-002-1) in cancers of the ovary, fallopian tube, or peritoneum (a membrane lining organs in the human body). We are anticipating opening of that trial once the FDA has reviewed the IND application.

    Mode of administration

    Intra-peritoneal (IP) administration of first-line chemotherapy to women with advanced stage ovarian cancer immediately after their debulking surgery has been recommended by the National Institute of Health in the USA since 2006. This mode of administration exposes residual tumor cells after surgery to higher doses of chemotherapy for longer periods compared with chemotherapy administered intravenously. Improvements in survival time with IP chemotherapy have lead national health and consumer advisory groups to continue to recommend this mode of administration for eligible groups of ovarian cancer patients.

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    Publications and Presentations

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    Milestones

    Second Half of 2016

    • First-in-human study with Cantrixil, pending successful completion of safety studies and human research ethics committee approval.
    • Complete Investigator’s brochure.
    • Complete clinical trial protocol.
    • Submit proposal to Human Research Ethics Committee.
    • Assessment of toxicity studies by independent external toxicologists.

    November 2015 - May 2016

    Formulation and stability testing of GMP product for Phase 1 clinical trial.

    January - December 2015

    Formal toxicity studies to assess safety of Cantrixil.

    August - November 2015

    Manufacture of cGMP grade Cantrixil drug substance for Phase 1 clinical trial – completed.

    January -August 2015

    Scale-up of manufacture of GLP-grade drug substance and drug product for toxicity studies – completed.

    November 2014

    Cantrixil proves highly effective in preclinical tests of refractory ovarian cancer.

    June 2014

    Researchers at Yale University confrm potency in ovarian stem cell model.

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