MIP-1095 is a PSMA-targeted small molecule radiopharmaceutical which is under development by Progenics for the treatment of prostate cancer (Press release Progenics Pharmaceuticals, MAR 13, 2014, View Source [SID:1234500273]).

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On March 12, 2014 TNI BioTech reported the U.S. Patent and Trademark Office (USPTO) has granted a key patent for IRT-101 (MENK) for inducing sustained immune response of T-Cells (Press release, TNI BioTech, MAR 12, 2014, View Source [SID:1234501364]).

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The present invention relates to methods of stimulating and promoting a sustained natural immune system response, resulting in increased resistance and inhibition of infectious agents, including viruses, bacteria, fungi and parasites, and other immunodeficiency-related ailments. More specifically, the invention relates to an intermittent dose schedule for promoting a sustained increased level of T-cell production (cytotoxic T-cells) including CD3, CD4, CD8, natural killer (NK) cells, CD38 cells, and interleukin II receptor. Pursuant to the patent, these therapies can be used on immunocompromised individuals including patients with cancer, or undergoing x-ray, surgery, or chemotherapy treatments.

The patent assigned to TNI BioTech from Nicholas Plotnikoff, which is already the subject of a previously granted U.S. patent, protects the activated NK cells. Similar patent protection has been obtained in India, Russia and the United Kingdom.

IRT-101 (MENK) is an active immunotherapy with MENK for patients with deficient functioning of the immune system. It works by restoring the patient’s immune functions and by activating the lymphocytes to attack cancer cells and infectious diseases, such as HIV/AIDS. This is accomplished because MENK binds to opioid receptors on both immune cells and on cancer cells, which directly inhibits the growth of cancer cells and increases the number and functions of T-cells, NK cells, NK-T cells, and gamma/delta T-cells. These cells then destroy infective organisms and tumor cells while simultaneously inhibiting the ability of T regulatory (Treg) cells to block the functions of anti-cancer or anti-infectious disease lymphocytes.

Noreen Griffin, CEO of TNI BioTech said, "We are pleased to be able to expand our patent portfolio and believe this patent plus the many other patents surrounding MENK provide us with broad composition-of-matter protection for our suite of immunotherapy treatments."

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.

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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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On March 11, 2014 Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced that a Phase 3 trial (NCT00692770) evaluating the investigational use of NEXAVAR (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival (Press release Amgen, MAR 11, 2014, View Source;p=RssLanding&cat=news&id=1907747 [SID:1234500257]). The safety findings were consistent with the known profile of sorafenib. Data from this study will be submitted for presentation at an upcoming scientific congress.

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