Progenics Pharmaceuticals, Inc.
) shares nosedived 27.4% after safety issues related to its
prostate-specific membrane antigen antibody drug conjugate (PSMA
ADC) were revealed in a meeting abstract ahead of the American
Society of Clinical Oncology's 2014 Genitourinary Cancers
Progenics is conducting a phase II trial (n = 70) to evaluate the
use of PSMA ADC for taxane-refractory metastatic castrate
resistant prostate cancer (mCRPC). Two doses of PSMA ADC: 2.5
mg/kg and 2.3 mg/kg are being evaluated in the study.
Several adverse events were found to be associated with the use
of both doses of PSMA ADC. While patients experiencing
neutropenia was higher for the 2.5 mg/kg dose (11.4%) compared to
the 2.3 mg/kg dose (6.7%), peripheral neuropathy was noticed in
more patients receiving the 2.3 mg/kg dose (6.7%) versus the 2.5
mg/kg dose (5.7%).
Two instances of death due to sepsis (a fatal whole-body
inflammation) were reported in patients receiving the 2.5 mg/kg
dose of PSMA ADC.
From an efficacy point of view, anti-tumor activity and reduction
in prostate-specific antigen (PSA) and circulating tumor cells
(CTC) was observed for both dosages.
We find the safety issues found to be associated with PSMA ADC
concerning. We believe that the company will find it challenging
to further develop and gain approval for this candidate given the
Currently several products including
) Taxotere and Jevtana and
Johnson & Johnson
) Zytiga are approved for mCRPC.
Further details on PSMA ADC will be provided by the company
shortly. Progenics plans to present data on 1404, its prostate
cancer imaging agent and PSMA ADC at the afore-mentioned meeting.
Progenics carries a Zacks Rank #3 (Hold). Some better-ranked
) carrying a Zacks Rank #1 (Strong Buy).
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