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APRIL 2015    A Monthly Review of Articles of Interest for the Clinical Community

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<This Month's Clinical Focus:<

<ORPHAN DRUGS>


About Orphan Drug Designations:  The FDA’s Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

Orphan drugs also are allowed to be tested on a smaller cohort of patients, and once commercialized, the manufacturer has 7 years of exclusive rights to market its product before a similar agent can be marketed by another manufacturer.

 

  FDA grants orphan drug status to pritumumab for brain cancer

According to the manufacturer’s website, pritumumab (Nascent Biotech) is a natural human IgG antibody derived from a B cell isolated from a tumor-draining lymph node of a patient with cervical cancer.

In multiple phase 2 trials conducted in Japan, patients with brain cancer treated with pritumumab had an overall response rate of 25% to 30%, with several survivors living beyond 5 years after therapy. Toxicities were minimal, confirming the safety of the agent, the website said.

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“Our data are comparable with the data generated in the earlier Japanese studies,” Mark Glassy, MD, chief science officer at Nascent Biotech, said in the release. “We anticipate that by modifying the dosing of the previous Japanese human clinical trials, during upcoming domestic human clinical trials, we have the potential to markedly improve response rates.”

Source:  http://www.healio.com/hematology-oncology/neuro-oncology/news/online/%7Bd8b8669f-df3a-4a51-bfa0-a4c7c0f0411f%7D/fda-grants-orphan-drug-status-to-pritumumab-for-brain-cancer
 


 

  FDA grants orphan drug designation to CUDC-907 for DLBCL


The FDA granted orphan drug designation to CUDC-907 for the treatment of diffuse large B-cell lymphoma.

CUDC-907 (Curis) — an oral, dual inhibitor of histone deacetylase and phosphoinositide 3-kinase enzymes — is currently being evaluated in a phase 1 clinical study composed of patients with relapsed or refractory lymphomas or multiple myeloma. The drug is also being evaluated in a phase 1 study of patients with advanced/relapsed solid tumors, including hormone receptor-positive, HER-2–negative breast cancer or midline carcinoma with certain NUT gene rearrangements.

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"We are pleased to receive Orphan Drug Designation for CUDC-907 in DLBCL, which represents an area of significant unmet need, especially in the relapsed/refractory setting," Ali Fattaey, PhD, president and chief executive officer of Curis, said in a press release. "We are continuing to treat DLBCL patients with CUDC-907 in the expansion stage of our phase 1 study and anticipate initiating a phase 2 trial in this indication in the second half of the year."

Source:  http://www.healio.com/hematology-oncology/hematologic-malignancies/news/online/%7B30e4e68f-34c4-4510-90b8-531b755c8f64%7D/fda-grants-orphan-drug-designation-to-cudc-907-for-dlbcl
 


 

  FDA grants orphan drug designation to IMO-8400 for DLBCL


Another orphan drug designation for DLBCL goes to Idera Pharmacauticals for IMO-8400.

IMO-8400  —  an antagonist of the endosomal Toll-like receptors (TLRs)  7, 8 and 9 —  is currently being evaluated in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who harbor a MYD88 L265P oncogenic mutation.

Preclinical study data — presented in 2014 at the American Association for Cancer Research Annual Meeting — suggested that IMO-8400 inhibited the survival and proliferation of human B-cell lymphoma cells harboring the oncogenic MYD88 L265P genetic mutation.

IMO-8400 has been well tolerated in a phase 1 dose-escalating trial composed of 42 healthy subjects who received doses up to 0.6 mg/kg for 4 weeks. The drug has also shown inhibition of immune responses mediated by TLRs 7, 8, and 9 in this population.

"The Orphan Drug designation granted today represents another positive milestone for our B-Cell Lymphoma clinical development program," James J. O'Leary, MD, Idera's interim chief medical officer, said. "We continue to advance our efforts in DLBCL."

Source:  http://www.healio.com/hematology-oncology/hematologic-malignancies/news/online/%7B212af5c1-38ec-4671-bba7-c67cafb98981%7D/fda-grants-orphan-drug-designation-to-imo-8400-for-dlbcl/comments

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