Radius (RDUS) Enrols First Patient in Breast Cancer Study

Radius Health, Inc. RDUS announced that the first patient has been enroled in the phase I study on pipeline candidate, RAD140.

RAD140 is a nonsteroidal selective androgen receptor modulator (SARM) which is being evaluated for the treatment of hormone receptor positive breast cancer. The phase I trial is a safety and dose-ranging study in approximately 40 patients suffering from progressive metastatic or locally advanced or metastatic breast cancer. Postmenopausal women with metastatic hormone receptor positive breast cancer will receive escalating doses of RAD140 by oral administration over a period of 28 days in part A of the study. The primary safety outcomes include rate of dose-limiting toxicities, adverse events related to treatment and tolerability as measured by dose interruptions or adjustments. In addition, pharmacokinetics, pharmacodynamics and tumor response will also be evaluated.

The SARM mechanism of action is differentiated from both selective estrogen receptor modulators (SERMs) and selective estrogen receptor degraders (SERDs). Consequently, RAD140 has significant potential to complement future applications of elacestrant (RAD1901) by targeting distinct mechanisms of endocrine resistance.

We note that an investigational new drug application submitted to the FDA for RAD140 has been accepted.

 

Radius’ share price has increased 1.4% year to date compared with the industry’s 4.6% gain.

In April the FDA approved Tymlos (abaloparatide-SC) for the treatment of postmenopausal women with high risk osteoporosis for fracture — defined as history of osteoporotic fracture — multiple risk factors for fracture, or patients who have failed or are intolerant to other osteoporosis therapies. Although the osteoporosis market in the United States holds great promise as approximately 1.4 million postmenopausal women suffer osteoporotic fracture each year, Tymlos is expected to face significant competition from Eli Lilly &Co's LLY Forteo and Amgen Inc's AMGN Prolia. Moreover, the approved label carries a boxed warning of osteosarcoma (a malignant bone tumor). The company, however, suffered a setback when the CHMP issued a second Day-180 List of Outstanding Issues.

Meanwhile, Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women.

Zacks Rank & Key Pick

Radius Health currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Aduro Biotech ADRO, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aduro Biotech’s loss per share estimates narrowed from $1.46 to $1.29 for 2017 and from $1.41 to $1.26 for 2018 over the last 60 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.

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