(CytoDyn) Jan 13, 2020 - CytoDyn Inc., a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of leronlimab as an adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC). The BTD filing is based on data from the first patient in the Company’s mTNBC Phase 1b/2 trial and an additional single-patient trial under an emergency investigational new drug (IND) protocol evaluating leronlimab for the treatment of HER2+ metastatic, stage 4, breast cancer (MBC).

Dean Gesme, MD (Posted: January 13, 2020)

C-C Chemokine Receptors (CCR5 or CD195) are ubiquitous on immune cells and play a significant role in inflammatory disorders and cancer. Antibodies targeting CCR5 are a welcome addition to our antineoplastic armamentarium.

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(ICR [UK]) Jan 13, 2020 - More targeted forms of radiotherapy can effectively treat bladder cancer which has spread to the lymph nodes of the pelvis, according to a new clinical trial.

Howard Sandler, MD, MS, FASTRO (Posted: January 13, 2020)

Radiotherapy as primary treatment (along with TUR and chemotherapy) is having a bit of a renaissance. The BC2001 study, using 5FU and mitomycin along with radiation, demonstrated a non-cisplatin regimen can be effective. Recently published RTOG 0712 (Coen JJ JCO 2019) showed that single agent gemcitabine can be used. Finally, SWOG/NRG have a large open bladder preserving trial testing whether bladder intact survival can be enhanced with immune checkpoint inhibition. Promising times for bladder preservation!

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(Reuters) Jan 13, 2020 - Veru Inc said on Monday a higher dose of its experimental drug reduced hot flashes in men with advanced prostate cancer after six weeks of treatment, in a mid-stage study.

Tomasz M. Beer, MD, FACP (Posted: January 13, 2020)

Hot flashes are a common consequence of hormonal therapy for prostate cancer and strategies to treat them are important for quality of survivorship. It is not surprising that an estrogenic drug would be effective. It will be important to learn more about any side effects that might emerge with additional studies.

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