CLINICAL TRIALS

Asking the right questions.
Addressing patient needs. Working with the right collaborators.

 

Scaling our clinical program to bring a unique new medicine to patients.

 

Successful clinical development.

PT-112 has been shown to be well tolerated and active in each of the three Phase I clinical trials. Peer-reviewed manuscripts have been published. Multiple posters and presentations at medical meetings have taken place. We have been fortunate to work with some of the field’s best clinical sites, including MD Anderson Cancer Center, Mayo Clinic, Memorial Sloan Kettering Cancer Center, Gustave Roussy (Paris), the National Cancer Institute, and others.

Below is a snapshot of our ongoing work in certain disease types, with others to follow.

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    PT-112 is currently in Phase 2 development in a defined population of mCRPC patients. Late-stage mCRPC patients have few options for life-prolonging therapy. Our belief is that PT-112’s unique combination of attributes is well suited to controlling and reducing the burden of this disease.

  • Thymoma

    There is no FDA approved treatment for thymoma and thymic carcinoma, or cancer of the thymus gland, a rare disease. Traditionally, treatment generally includes some combination of surgery, chemotherapy and/or radiation therapy. PT-112 is under Phase 2 clinical development at the National Cancer Institute (NCI) for this rare disease.

    PT-112 has FDA Orphan Drug Designation in this disease.

  • Non-Small Cell Lung Cancer (NSCLC)

    Following the introduction of immune checkpoint inhibitors in this disease, there remains an opportunity to increase response rates and duration of response.

    We are exploring the role of PT-112 alone and in combination with I-O therapy in this disease setting.

  • Relapsed or Refractory Multiple Myeloma (RRMM)

    Multiple myeloma is an area of substantial recent advances in cancer care. Nonetheless, there remains a large population at high risk of death following the use of available therapies. A Phase I study of PT-112 has been reported at ASH and is the subject of a pending manuscript.

    PT-112 has FDA Orphan Drug Designation in this disease.

  • Other Indications

    We continue to explore the wide range of opportunities for PT-112 in other disease settings with unmet needs.

Our Pipeline

 

[1] American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019.

[2] Siegel RL, Miller KD, Jemal A: Cancer statistics, 2018. CA Cancer J Clin 2018; 68: 7.

[5] U.S. National Institute Of Health, National Cancer Institute. SEER Cancer Statistics Review, 1975–2015.

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