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AMHR2 and 3C23K

The anti-AMHR2 product (3C23K) which is under development by GamaMabs is an Emabling engineered humanized mAb directed against the receptor of the anti-Müllerian hormone (AMHR2), alternatively known as Müllerian Inhibiting Substance Receptor II (MISRII) (Company Pipeline GamaMabs Pharma, MAR 12, 2014, View Source [SID:1234500268]).

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Geron Announces IND Clinical Hold Affecting Clinical Trials of Imetelstat in Essential Thrombocythemia and Multiple Myeloma

On March 12, 2014 Geron reported that the company has received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for imetelstat has been placed on full clinical hold, affecting all ongoing company-sponsored clinical trials (Press release Geron, MAR 12, 2014, View Source;p=RssLanding&cat=news&id=1908172 [SID:1234500269]). A full clinical hold is an order that the FDA issues to a trial sponsor to suspend an ongoing clinical trial or delay a proposed trial.
The clinical hold affects the remaining eight patients in the company’s Phase 2 study (NCT01731951) in essential thrombocythemia (ET) or polycythemia vera (PV) and the remaining two patients in the company’s Phase 2 study (NCT01242930) in multiple myeloma. In addition, the company’s planned Phase 2 clinical trial in myelofibrosis will likely be delayed due to the clinical hold. It is possible that other studies using imetelstat, such as ongoing investigator-sponsored trials, may also be placed on clinical hold by the FDA.
Geron has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication yesterday afternoon, the FDA indicated that the clinical hold is due to the occurrence of persistent low-grade liver function test (LFT) abnormalities observed in the Phase 2 study of imetelstat in ET/PV patients and the potential risk of chronic liver injury following long-term exposure to imetelstat. The FDA expressed concern about whether these LFT abnormalities are reversible. Geron plans to work diligently with the FDA to seek the release of the clinical hold.

(Press release, Selvita, MAR 11, 2014, View Source [SID:1234504706])

TG Therapeutics, Inc. Announces $18.1 Million Underwritten Sale of Common Stock to a Single Institutional Investor

On March 11, 2014 TG Therapeutics announced it has priced an underwritten sale of 2,702,809 shares of its common stock at $6.71 per share, the closing price on March 11, 2014, to JP Morgan Asset Management’s Global Healthcare Fund. Gross proceeds from the sale are expected to be approximately $18.1 million (Press release TG Therapeutics, MAR 11, 2014, View Source [SID:1234500264]). TG Therapeutics intends to use the proceeds from the offering to fund the clinical development of TG-1101 and TGR-1202 and other general corporate purposes. The offering is expected to close on or about March 17, 2014, subject to customary closing conditions.
Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, commented on the transaction, "We are very excited to have consummated this financing with a premier biotechnology investor. The proceeds from the financing and existing cash provide us with funding to support our current and planned clinical programs for the next several years as well as flexibility to opportunistically acquire additional complimentary products or technologies."

Human medicines European public assessment report (EPAR): Yervoy, ipilimumab, Revision: 4, Authorised

On March 11, 2014 a periodic safety update was reported to have been added to the EPAR for Yervoy (External Source EMA, Bristol-Myers Squibb, MAR 11, 2014, View Source [SID:1234500262]).
A review of cases of anaphylaxis or cytokine release syndrome events identified a total of 6 cases: two of the 6 cases had limited information for assessment. Nevertheless, there have been cases of anaphylactic reactions, resulting in hospitalization in at least one patient; and for which stopping the medication and supportive care was needed in all reported cases. Due to the characteristics of the cases (rapid time to onset and severity of the events) the PRAC considered that anaphylactic reactions should be included in section 4.8 of the SmPC, with a frequency based on clinical trials, i.e. very rare (<0.01% (1/12881)). The package leaflet is updated accordingly. The CHMP agrees with the scientific conclusions made by the PRAC. Commission decision was issued on DEC 18, 2013.