On March 18, 2014 Astellas and Medivation reported the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy (Press release Astellas, MAR 18, 2014, View Source [SID:1234500305]). XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.
The sNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-naïve mCRPC patients. The marketing authorization application is expected to be submitted to the European Medicines Agency later this year.
Pierre Fabre obtains FDA Approval to market HemangeolTM for the Treatment of Infantile Hemangioma
On March 17, 2014 Pierre Fabre Dermatologie has obtained marketing authorization from the FDA* for the pediatric drug HemangeolTM (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy" (Press release, Pierre Fabre, MAR 17, 2014, View Source [SID1234591858]). Hemangeol is an oral solution specially developed for safe and effective use in children. Hemangeol will be available June 2014. This marketing authorization comes after the new drug application for Hemangeol was submitted to the US FDA in May 2013. The application was also submitted to the European Medicines Agency, receiving positive opinion on February 21st, 2014 from the CHMP**, with marketing authorization expected for April 28th, 2014.The efficacy of propranolol in the treatment of infantile hemangioma (IH) was first discovered in 2007 by Dr. Christine Léauté-Labreze, a dermatologist at the Bordeaux University Hospital. Subsequently, the off-label use of this molecule became the first-line treatment for IH. While propranolol has long been known and used in cardiology, its use in infants with IH had never been properly studied and there was no pharmaceutical form approved for pediatric use. In 2009, Pierre Fabre Dermatologie undertook the pharmaceutical and clinical development required to make the Bordeaux University Hospital discovery accessible to infants with IH, with proven clinical safety and efficacy.
This collaboration has endowed pediatric dermatology with a new therapy that fulfills an unmet medical need and thousands of American children may now benefit from this new therapy each year, declared Dr. Jean-Jacques Voisard, Dermatologist, General Manager of Pierre Fabre Dermatologie.
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As Pierre Fabre US representatives we are proud to be part of a Group able to develop children dedicated medicines and to be the first Pierre Fabre subsidiary to obtain marketing approval for Hemangeol, underlined Laurent-Emmanuel Saffré, General Manager of Pierre Fabre Pharmaceuticals, Inc. (USA).
The marketing authorization granted by the FDA rewards a public–private partnership developed over the last six years by Pierre Fabre Laboratories and the Bordeaux University Hospital, with the support from Aquitaine Science Transfert, stated Eric Ducournau, CEO of Pierre Fabre Dermo-cosmetics SAS, parent company of Pierre Fabre Dermatologie.
Following the marketing authorization approved by the FDA in July last year for Fetzima (levomilnacipran extended-release capsules), a drug created by Pierre Fabre research and developed in partnership with Forest Laboratories, the Hemangeol marketing authorization is yet further recognition for our R&D on the world’s most demanding pharmaceutical market. This is a tremendous encouragement to pursue our R&D effort in oncology, dermatology and neuropsychiatry which are our prioritized therapeutic areas of innovation,commented Bertrand Parmentier, CEO of the Pierre Fabre Laboratories.
20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]
BioLineRx has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Press release BioLineRx, MAR 17, 2014, View Source [SID1234500298]).
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First Cancer Trial Launched Using CAR T Cells Engineered with Bellicum’s Safety Switch
On March 17, 2014 Bellicum Pharmaceuticals reported that the first clinical study is underway of a Chimeric Antigen Receptor (CAR) T Cell therapy that incorporates a safety switch to enable rapid elimination of the administered T cells if they threaten the life or health of the patient. Researchers from the National Cancer Institute (NCI) have begun treating pediatric patients with osteosarcoma and other non-neuroblastoma GD2-expressing solid tumors with a third generation CAR T cell therapy that incorporates Bellicum’s unique CaspaCIDe safety switch technology (Press release Bellicum Pharmaceuticals, MAR 17, 2014, View Source [SID:1234500805]).
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"CAR T cell therapy has recently shown dramatic results including apparent cures in some of the deadliest of cancers, but the treatment can also cause life-threatening toxicities, and has resulted in some patient deaths. Experts in the field have talked about the critical need for an effective safety mechanism to allow the development of more potent products within this new class of immunotherapy," said Kevin Slawin, M.D., Executive Chairman and Chief Medical Officer of Bellicum Pharmaceuticals. "We’re excited to make this a reality by incorporating our unique safety switch into this third generation CAR T cell therapy, thereby potentially giving these patients, and their families and physicians, an added layer of safety."
Bellicum’s CaspaCIDe technology consists of an inducible Caspase-9-based cell safety switch, and the small molecule activator, AP1903. CaspaCIDe is engineered into immunotherapy cells, in this case GD2-targeted third generation CAR T cells, before they are introduced to the patient. In the event of a serious or life-threatening toxicity caused by the administered T cells, AP1903 is infused to trigger rapid destruction and elimination of the CaspaCIDe-enabled cells.
CaspaCIDe technology has already demonstrated the ability to selectively eliminate harmful immune cells, resolving acute Graft versus Host Disease (GvHD) in stem cell transplant patients.1 Bellicum is currently evaluating its own lead CaspaCIDe-enabled product, BPX-501, together with AP1903, in clinical studies to improve transplant outcomes and reduce or eliminate GvHD following stem cell transplant in multiple indications, populations and transplant modalities. The collaboration with NCI represents Bellicum’s initial application of its expertise and technology to the clinical advancement of the CAR T cell field.
AMORFIX AND TRELLIS BIOSCIENCE TO COLLABORATE ON ANTI-CD38 ANTIBODY TREATMENT FOR CANCER
On March 17, 2014 Amorfix Life Sciences reported that it has entered into a collaboration with Trellis Bioscience to develop antibodies against misfolded CD38 protein as a treatment for hematological malignancies including leukemia and lymphoma (Press release Amorfix Life Sciences, MAR 17, 2014, View Source [SID:1234500301]).
Trellis is a private, South San Francisco-based therapeutic antibody company formed around a breakthrough discovery platform capable of isolating therapeutic grade antibodies directly from the blood cells of humans. The Company’s discovery platform, called CellSpotTM, uses computerized microscopy to drastically miniaturize a multiplexed antigen binding assay capable of characterizing millions of individual antibody producing B cells. Hence, CellSpot enables discovery of very rare high quality human antibodies usually not detectable with standard techniques.
Amorfix’s ProMIS Discovery technology identifies disease specific epitopes (DSE’s) that are present only on diseased cells. Together, the complementary technologies will enable the companies to isolate and develop fully human therapeutic antibodies that will target only cancer cells and not healthy ones. Under the terms of the collaboration, Amorfix will have an exclusive option to develop any resulting antibodies.