Henderson, NV and San Diego, CA (Press Release) – Secura Bio, Inc. (www.securabio.com), an integrated, commercial-stage bio­pharma­ceu­tical com­pany dedicated to the world­wide com­mer­cial­iza­tion of sig­nif­i­cant on­col­ogy ther­a­pies, today announced that it has acquired the global rights to Farydak® (panobinostat) from Novartis.

Farydak® (panobinostat) is a prescription oral medication used in com­bi­na­tion with pro­te­a­some inhibitors and corticosteroids to treat patients with re­lapsed or refractory multiple myeloma who had received prior treat­ments. Farydak is a member of the histone deacetylase (HDAC) inhibitor family with a very potent and unique mode of action slowing the growth …

• Farydak (panobinostat) combination is approved in the EU for patients with multiple myeloma who received >=2 prior regimens including bortezomib and IMiD[1]
• In clinical trials, Farydak combination increased PFS by 7.8 months in patients who received >=2 prior regimens, including bortezomib and an IMiD[1]
• As the first HDAC inhibitor approved in the EU for multiple myeloma, Farydak may help reset key cell function in multiple myeloma through epigenetic activity[2]
• Farydak is approved in the US and Japan

 …

An advisory committee of the European Medicines Agency has issued a positive opinion regarding European approval of Farydak (panobinostat) for the treat­ment of cer­tain patients with multiple myeloma.

Specifically, the Committee for Medicinal Products for Human Use (CHMP) rec­om­mended that Farydak be approved for use in com­bi­na­tion with Velcade (bor­tez­omib) and dexa­meth­a­sone (Decadron) for the treatment of re­lapsed and/​or refractory multiple myeloma patients who have received at least two prior treatment regimens.

The two prior regimens must include Velcade and at least one treatment from the immunomodulatory class of drugs, …

• Farydak (panobinostat) combination improved PFS by 7.8 months for patients who received >=2 prior regimens including bortezomib and an IMiD[1]
• Farydak would be the first HDAC inhibitor with epigenetic activity to treat multiple myeloma[2],[3]
• CHMP positive opinion marks a key milestone toward panobinostat availability in the EU, aligning with recent US FDA approval

Basel, Switzerland (Press Release) – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion …

A poster session yesterday at the 2015 American Society of Clinical Oncology (ASCO) annual meeting was the venue for the first substantial dose of multiple myeloma-related presentations at the conference.

During the session, research results were made available for review by meeting attendees in the form of posters, each of which summarized the results of a single study. As is typically the case during such sessions, each poster was about two feet high by three or four feet in length. All posters were displayed throughout a large conference hall.

Most of the …

The 51st annual meeting of the American Society of Clinical Oncology (ASCO) started earlier to­day, May 29, and will go through June 2 in Chicago.

Approximately 30,000 physicians and re­searchers from all over the world are ex­pec­ted to attend the five-day meeting to discuss cur­rent re­search in cancer treat­ment and care.

During the meeting, there will be pre­sen­ta­tions about all types of cancer, in­clud­ing many pre­sen­ta­tions focused spe­cif­i­cally on mul­ti­ple myeloma. In fact, more than 90 myeloma-related stud­ies are scheduled to be pre­sented, in one form or another, in con­nec­tion with the …

The results of a small Phase 1/2 clinical trial suggest that a com­bi­na­tion of Farydak and high-dose Kyprolis is effective as a treat­ment for re­lapsed multiple myeloma.

Participants in the trial were heavily pretreated, having had a median of five pre­vi­ous myeloma ther­a­pies. More than 70 per­cent of the patients, however, had at least a partial re­sponse to the trial regi­men at the target doses established during the trial’s first phase. The esti­mated two-year over­all survival rate among the patients was 67 per­cent.

A response rate of more than 70 per­cent is …