On January 15, 2016 Heron Therapeutics, Inc. (NASDAQ:HRTX), reported that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 and anticipates taking action in late February 2016 (Press release, Heron Therapeutics, JAN 15, 2016, View Source [SID:1234508795]). Schedule your 30 min Free 1stOncology Demo! SUSTOL is a long-acting formulation of the FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist granisetron being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). SUSTOL is formulated utilizing Heron’s proprietary Biochronomer drug delivery technology, and has been shown to maintain therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection.
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GP Pharm has recently launched Lutrate® Depot trimestral in Spain
On January 14, 2016 GP Pharm reported that it has recently launched Lutrate Depot trimestral in Spain (Press release, GP Pharm, JAN 14, 2016, View Source [SID1234591043]). Lutrate Depot is a new microsphere formulation of leuprolide acetate. The product is based on the in-home based patented technology of GP Pharm and is indicated for the treatment of prostate cancer. The product complements the offer of GP Pharm in the Spanish market where the 1 month formulation was currently available.
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10-Q – Quarterly report [Sections 13 or 15(d)]
(Filing, 10-Q, Generex, JAN 14, 2016, View Source [SID:1234508793])
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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Apogenix Strengthens U.S. Patent Position for Lead Immuno-Oncology Candidate APG101
On January 14, 2016 Apogenix, a biopharmaceutical company developing next generation immuno-oncology therapeutics, reported that it has received Notices of Allowance from the U.S. Patent and Trademark Office for two key patents for lead immuno-oncology candidate APG101 (Press release, Apogenix, JAN 14, 2016, View Source [SID1234524580]). The so-called method of use patent covers the use of CD95 ligand inhibitors, such as APG101, for the treatment of glioblastoma. This patent is valid at least until 2029. The so-called composition of matter patent protects APG101 as a product as well as its manufacturing process at least until 2033.
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"Apogenix already has a broad patent portfolio covering APG101. These two patents greatly expand the protection of APG101 and its use in the treatment of glioblastoma," said Thomas Hoeger, Ph.D., CEO of Apogenix. "The prospective granting of these two patents in the most important pharmaceutical market further validates our innovative drug development approach and the therapeutic potential of CD95 ligand inhibitors for the treatment of malignant brain tumors, among other indications."
The efficacy, safety, and tolerability of APG101 were demonstrated in a controlled phase II proof-of-concept trial in patients with recurrent glioblastoma. Treatment with APG101 in combination with radiotherapy has shown clinical superiority in all study endpoints compared to treatment with radiotherapy alone, resulting in an overall survival benefit in glioblastoma patients treated with APG101. Interim data of a phase I trial with APG101 for the treatment of myelodysplastic syndromes further indicate the efficacy of APG101 in this hematological disease.
8-K – Current report
On January 14, 2016 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, reported the initiation of Selinexor in Advanced Liposarcoma ("SEAL"), a new Phase 2/3 clinical trial with oral selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound that inhibits exportin 1 (XPO1)(Filing, 8-K, Karyopharm, JAN 14, 2016, View Source [SID:1234508821]).
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SEAL is a multi-center, randomized, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating single-agent oral selinexor in patients with advanced unresectable dedifferentiated liposarcoma. Patients will be randomized to receive either 60mg of selinexor or placebo given twice weekly per six week cycle until progression or intolerability. Fifty patients are expected to be enrolled in the Phase 2 portion of the study, with the potential to increase enrollment in the Phase 3 portion following an interim analysis. The primary endpoint of progression free survival (PFS) was acceptable to the Food and Drug Administration (FDA). Top-line data from the Phase 2 portion of this study are expected in early 2017.
"The rationale for SEAL is based on data from a Phase 1b study demonstrating durable stable disease with single-agent selinexor in patients with liposarcoma and other sarcomas," said Mrinal M. Gounder, MD, Attending Physician, Sarcoma Service and Developmental Therapeutics Service, Memorial Sloan Kettering Cancer Center, and Lead Investigator of the SEAL trial. "These data, presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2015 Annual Meeting in June, showed durable responses in liposarcoma, leiomyosarcoma and other sarcomas. Patients with liposarcoma appeared to benefit the most with selinexor, showing an improvement in progression free survival compared to previous chemotherapies." In the Phase 1b study, selinexor showed longer disease control duration compared to the patient’s most recent prior therapy, with 14 of 18 liposarcoma patients (78%) achieving stable disease, including six (43%) of these fourteen patients achieving stable disease for greater than four months.
"With a less-than-5% five-year survival rate for recurrent and high-grade forms of liposarcoma, there are few effective treatment options for these uncommon, difficult to treat tumors that arise from the body’s fat tissue," said Sant P. Chawla MD, Director, Santa Monica Oncology Center, Sarcoma Oncology Center. "Extending progression free survival is an important goal for these patients, in whom the rapid progression of disease frequently translates into early mortality. I look forward to seeing how encouraging early results from selinexor in sarcomas, in which extended disease stabilization was observed, translate to this larger outcome study."
"With our pivotal clinical strategy for selinexor in hematologic malignancies moving toward several key top line readouts, initiation of the SEAL study signals an important expansion of this strategy into solid tumors," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We believe selinexor offers the potential to provide a still deeply underserved liposarcoma patient population with a new therapeutic option. We look forward to the advancement of this study and to the launch of additional randomized studies of selinexor in solid tumors, as well as hematologic malignancies, where high unmet medical needs persist."