Pipeline updates for KERX ZCLS CLDX BCRX SPPI FOLD ISTA ARIA SNTS PCYC

May 05, 2011 No Comments by

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) today announced the pricing of an underwritten registered offering of 7,021,277 shares at $4.70 per share.

Zalicus Inc. (NASDAQ: ZLCS) maintained previous guidance that they intend to initiate a Phase 2b clinical trial of Synavive for rheumatoid arthritis (RA) in 2Q 2011.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) maintained previous guidance that they intend to initiate a Phase 3 randomized, placebo-controlled study of rindopepimut for GBM during 2H 2011. Enrolment is ongoing in their 120-patient randomized Phase 2b controlled study of CDX-011 for refractory breast cancer, due to fully enrolled by year-end 2011. CLDX also mentioned that they reduced the overall number of patients and expanded eligibility in the Phase 2 study of CDX-1307 in bladder cancer by amending the trial design to a single-arm study.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) also maintained guidance that they expect to complete enrollment of their Phase 2b trial for gout by late-2011.

Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced today that they intend to file their NDA for Belinostat in 2012 with enrollment expected to be completed in the PTCL Trial in 2011. Previous guidance was for an NDA filing in 2011 or 2012.

Amicus Therapeutics (Nasdaq: FOLD) gave a pipeline update today noting the following:

Enrollment in Phase 3 Amigal study (Study 011) is expected to be fully enrolled in 2Q11 or 3Q11.

Initiate Study 012, the Phase 3 EU registration study of Amigal for Fabry disease, in 2Q11 or 3Q11.

Initiate Phase 2 study of AT2220 co-administered with ERT for Pompe disease in 3Q11, with results expected in 1H12.

ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), gave an update today noting that they had initiated the low-concentration BROMDAY Phase 3 trial this week. They plan to initiate a Phase 2 study in Mountain Cedar pollen with bepotastine besilate/steroid combination nasal spray before the end of 2011. They also on track to report topline Phase 3 efficacy and short-term safety results for REMURA(TM) for dry eye by early 2H 2011.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) gave a pipeline update today noting that patient enrollment in the pivotal Phase 2 PACE trial of ponatinib, for patients with chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph ALL) is six months ahead of schedule. Enrollment is expected to be completed during 3Q 2011, with a possible NDA filing mid 2012.

Santarus, Inc. (NASDAQ: SNTS) maintained previous guidance that their Phase 3 trial of RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) will be completed by the 3Q 2012.

Pharmacyclics, Inc. (Nasdaq: PCYC) today gave a pipeline update noting the following:

PCI-32765 in B-cell Malignancies – Phase 2 clinical development program in chronic lymphocytic leukemia, mantle cell lymphoma and diffuse large B-cell lymphoma is ongoing. 185 patients have been treated with an additional 200 to be treated this year.

PCI-32765 Phase 2 CLL-SLL – updated data will be presented at ASCO.

Chronic Lymphocytic Leukemia-Small Cell Lymphocytic Lymphoma (CLL-SLL) – Phase 2 study of PCI-32765 in combination with ofatumumab (PCYC-1109) and a Phase 2 study of PCI-32765 in a combination with either bendamustine-rituximab (BR) or fludarabine-cyclophosphamide and rituximab (FCR) (PCYC-1108). Enrolment due to be completed 2H 2011.

Mantle Cell Lymphoma (MCL) – (PCI-32765) – Expect to complete enrollment by the end of calendar 2011.

Diffuse Large B-cell Lymphoma (DLBCL) – Phase 2 study of PCI-32765 in patients with relapsed or refractory DLBCL (PCYC-1106) is currently in start-up phase in 15 US sites with enrollment completed during 1Q 2012.

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Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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