On May 19, 2014 Sophiris Bio reported it has entered into a common stock purchase agreement with Aspire Capital Fund. The Company intends to use the initial proceeds to support a proof of concept study of PRX302 as a treatment for localized prostate cancer (Filing 8-K , Sophiris Bio, MAY 19, 2014, View Source [SID:1234500532]). Aspire Capital has completed an initial purchase of 604,320 common shares at $3.31 per share for proceeds of $2 million and has committed to purchase up to $13 million in additional shares over the next 30 months at prices based on market price at the time of each sale, subject to a Sophiris registration statement being declared effective by the Securities and Exchange Commission (“SEC”).

“While we remain focused on our Phase 3 trial in benign prostatic hyperplasia (BPH), this financing provides us with additional financial flexibility and supports the advancement of PRX302 into another important, underserved indication. The highly targeted mechanism by which PRX302 selectively destroys prostate tissue in BPH also represents a promising treatment approach for localized prostate cancer,” said Randall E. Woods, president and chief executive officer. “The $2 million proceeds from this transaction will enable us to fund an investigator-sponsored proof of concept study in localized prostate cancer. The remaining $13 million available under the purchase agreement, if drawn down at the Company’s option, will be utilized to fund future development of PRX302 in BPH and localized prostate cancer as well as general corporate purposes.”

The Company will provide additional details around the design of the proof of concept study in localized prostate cancer upon the initiation of the study. Localized prostate cancer is a disease that is confined to the prostate gland and has not spread to the tissue and lymph nodes that surround the prostate gland or other parts of the body. PRX302 has been engineered to be activated by enzymatically active prostate specific antigen (PSA), which is found in the transition zone of the prostate as well as in prostate cancer cells. In the 126 patients studied in completed BPH clinical trials, PRX302 appears to be safe and well tolerated with no impact on erectile function.

Under the terms of the common stock purchase agreement, Sophiris will control the timing and amount of any sale of common shares to Aspire Capital. Aspire Capital has no right to require any sales by Sophiris but is obligated to make purchases as Sophiris directs, in accordance with the purchase agreement. There are no limitations on the use of proceeds, financial covenants or restrictions on future financings and there are no rights of first refusal, participation rights, penalties or liquidated damages in the purchase agreement. The purchase agreement may be terminated by Sophiris at any time, at its discretion, without any additional cost or penalty. Sophiris has issued 90,635 common shares to Aspire Capital as a commitment fee in connection with the execution of the purchase agreement. The common shares issued or to be issued under the purchase agreement will be registered for resale pursuant to a registration statement to be filed by Sophiris with the SEC. A complete and detailed description of the purchase agreement and related registration rights agreement is set forth in the Company’s Current Report on Form 8-K, filed today with the SEC.

On May 19, 2014 GlaxoSmithKline and Genmab reported that the Phase III study (ORCHARRD/NCT01014208) of ofatumumab (Arzerra) plus chemotherapy versus rituximab plus chemotherapy to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint as there was no statistically significant difference in progression free survival (PFS) between the treatment arms (Press release Genmab, MAY 19, 2014, View Source [SID:1234500531]).
There were no differences in adverse events (AEs) leading to treatment discontinuation, Grade ≥3 AEs, severe adverse events (SAEs) or fatal SAEs between the treatment arms. However, there were more dose interruptions and delays due to infusion reactions and increased serum creatinine in the ofatumumab plus chemotherapy arm, which require further analysis.

On May 19, 2014 Clovis Oncology reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CO-1686 as monotherapy for the treatment of second-line EGFR mutant NSCLC in patients with the T790M mutation (Press release Clovis Oncology, MAY 19, 2014, View Source [SID:1234500530]). The Breakthrough Therapy designation was granted based on interim efficacy and safety results from an ongoing Phase 1/2 study of CO-1686. CO-1686 is the Company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M.
Interim results from an ongoing Phase 1/2 study of CO-1686 were presented at the 4th European Lung Cancer Conference (ELCC) in Geneva in late March. An objective response rate of 64 percent in 14 of 22 evaluable T790M positive patients was observed. CO-1686 is well-tolerated, with only one patient who discontinued treatment with CO-1686 due to adverse events. There was no evidence of systemic wild-type EGFR inhibition.
The next update of CO-1686 clinical data will be presented at the 2014 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in a Clinical Science Symposium titled, “Targeting EGFR: The Next 10 Years”, taking place on Saturday, May 31 in Chicago.
The Company is currently enrolling two Phase 2 expansion cohorts of its Phase 1/2 study in EGFR mutant patients with the T790M mutation. Data from the expansion cohorts, combined with data from the TIGER2 study, in T790M positive patients directly after progression on their first and only TKI therapy, are expected to serve as the basis of an NDA submission for CO-1686 by mid-2015.

On May 19, 2014 Bristol-Myers Squibb and AbbVie reported that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies (Press release Bristol-Myers Squibb, MAY 19, 2014, View Source [SID:1234500527]). The designation is based on findings from a randomized Phase 2, open-label study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated patients, including the 10 mg/kg dose that is being studied in Phase 3 trials. Data from the Phase 2 trial were most recently presented at the 18th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in 2013.