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10-Q – Quarterly report [Sections 13 or 15(d)]

Epizyme has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Epizyme, APR 28, 2015, View Source [SID1234503203]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Hospira has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Hospira, APR 28, 2015, View Source [SID1234503193]).

8-K – Current report

On April 28, 2015 Bio-Path Holdings reported that they have received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its lead compound Liposomal Grb-2 for the treatment of acute myeloid leukemia (AML) (Filing, 8-K, Bio-Path Holdings, APR 28, 2015, View Source [SID:1234503201]). Orphan drug status provides Bio-Path with seven years of exclusivity after receiving formal marketing approval, as well as additional development incentives. The FDA grants this designation to certain drugs that are targeting diseases affecting fewer than 200,000 people in the United States.

"This designation from the FDA demonstrates the unmet need for an effective therapy for patients suffering from AML," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "It also marks a key regulatory milestone for Bio-Path and will be valuable as we continue to progress Liposomal Grb-2 through clinical trials and toward potential commercialization."

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Liposomal Grb-2 is currently in a safety segment of a Phase 2 trial in combination with Ara-C, for acute myeloid leukemia; and is being evaluated for chronic myelogenous leukemia.

Pre-clinical development is underway for triple negative and inflammatory breast cancers.

About Acute Myeloid Leukemia

AML is a fast-growing cancer of the blood and bone marrow where the bone marrow makes many cancerous cells called leukemic blasts. Normal blasts develop into white blood cells that fight infection. In AML, the leukemic blasts do not develop properly and cannot fight infections. These leukemic blasts grow quickly and crowd out the bone marrow, preventing it from making the normal red blood cells, white blood cells, and platelets that the body needs.
Nearly 15,000 people in the United States are diagnosed with AML each year.

About Growth Receptor Bound protein-2 (Grb-2)

The adaptor protein Growth Receptor Bound protein-2 (Grb-2) is essential to cancer cell signaling because it is utilized by oncogenic tyrosine kinases to induce cancer progression. Suppressing the function or expression of Grb-2 should interrupt its vital signaling function and have a therapeutic application in cancer. BP-1001 is a neutral-charge, liposome-incorporated antisense drug substance designed to inhibit Grb-2 expression.

PTC Therapeutics’ Cancer Stem Cell Program Targeting BMI1 Enters Phase 1

On April 28, 2015 PTC Therapeutics reported that its oncology program targeting BMI1, a protein linked to drug-resistant cancers, has entered a Phase 1 study in patients with advanced solid tumors (Press release, PTC Therapeutics, APR 28, 2015, View Source [SID:1234503200]). The open-label, first-in-human study will investigate the safety and pharmacokinetics of PTC596, an orally available small molecule. PTC’s BMI1 program is supported by a collaboration with the Wellcome Trust.

BMI1 has been implicated in a wide variety of cancers and has been demonstrated to contribute to therapeutic resistance and treatment failure. BMI1 is thought to play a role in the survival and maintenance of tumor stem cells in many cancers, including central nervous system cancers such as glioblastoma. Elevated levels of BMI1 have been associated with advanced tumor grade and a poor prognosis.

"We’re excited to begin clinical trials for PTC596, an investigational drug that targets an important stem cell regulator, BMI1, which is elevated in a wide array of tumor types," said Robert Spiegel, M.D., Chief Medical Officer, PTC Therapeutics, Inc. "In preclinical models, PTC596 reduced BMI levels leading to depletion of the cancer stem cell population. Importantly, we saw this effect when PTC596 was used alone and in combination with current standards of care."

"Targeting cancer stem cells by BMI1 inhibition is a promising approach to address the challenge of drug-resistant cancers," stated Lillian Siu, M.D., Princess Margaret Cancer Center, Professor of Oncology, University of Toronto. "Cancer is a complex problem and the development of treatments that focus on molecular targets shows promise for the next generation of cancer therapies to make a difference in patients’ lives."

PTC’s collaboration with the Wellcome Trust began in June 2010 when the Wellcome Trust awarded PTC $5.4 million to support the development of drugs that target BMI1.

First Patient Dosed by Alligator Bioscience in a Clinical Phase 1 Multicenter Trial

On April 27, 2015 Alligator Bioscience AB reported that the first patient was dosed early last week in the recently initiated phase 1 clinical trial of the immuno-oncology antibody ADC-1013 (Press release, Alligator Bioscience, APR 27, 2015, View Source [SID1234538694]). ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immune-stimulatory receptor found on antigen-presenting cells such as dendritic cells.

The clinical phase 1 trial is a first-in-human trial for patients with advanced solid tumor disease. Dr. Per Norlén, Chief Medical Officer at Alligator Bioscience, commented that "we are very pleased to confirm that dosing of the first patient was successful. The interest for participation in our first-in-human trial has been massive, allowing dosing of the first patient at Uppsala University Hospital, Sweden, within 3 weeks of starting recruitment. ADC-1013 was well tolerated and not associated with any significant adverse reactions. Currently we have opened 2 clinical sites, and expect all 5 sites to be active shortly."

As mentioned in a previous press release April 7, the study will enroll up to 40 patients during the dose escalation and expansion phases at five centers in the United Kingdom, Denmark and Sweden.