ZIOPHARM Presents Positive Data From Phase I Study Of Palifosfamide In Combination With Doxorubicin At ASCO

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced that it presented final data from a Phase I study of palifosfamide (ZymafosTM) in combination with doxorubicin at the 45th Annual American Society of Clinical Oncology (ASCO) meeting held in Orlando, FL, May 29th to June 2nd.

The Phase I trial of palifosfamide in combination with doxorubicin was fully enrolled with 13 patients, predominantly with soft tissue sarcoma and non-small cell lung cancer, and who had received a median of two prior therapies. Of 12 evaluable patients, there were 3 partial responses. Of the 8 patients with soft tissue sarcoma (STS) 75 percent had stable disease or better, with 2 having partial responses and 4 having prolonged stable disease. The median progression free survival (PFS) was 19 weeks.

ImmunoGen, Inc. Announces Encouraging Trastuzumab-DM1 Phase II Clinical Findings Presented At ASCO

ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, announced the presentation of encouraging trastuzumab-DM1 (T-DM1) clinical data at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place in Orlando, Florida.

T-DM1, an antibody-drug conjugate, consists of ImmunoGen’s DM1 cancer-cell killing agent linked to the HER2-targeted antibody, trastuzumab, developed by Genentech, Inc. (a wholly-owned member of the Roche Group). Genentech (US) and Roche (ex-US) are conducting a broad clinical program with T-DM1 in HER2-positive breast cancer.

Catalyst Pharmaceutical Partners Announces Top-Line Results Of CPP-109 Phase II Trial For Cocaine Addiction

Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) announced top-line results from its U.S. Phase II clinical trial to treat cocaine addiction. The data from the trial showed that CPP-109 did not demonstrate statistical significance in the primary endpoint — that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 11 and 12). The clinical trial did not reveal any unexpected “serious” adverse events.

Personalized Anti-Cancer Vaccine Pivotal Phase III Results To Be Presented At ASCO Plenary Session

Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), announced that BiovaxID, Biovest’s personalized anti-cancer vaccine targeting B-cell blood cancers, will be featured in an oral presentation during the Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31st, 2009 in Orlando, Florida.

Stephen J. Schuster, M.D., Associate Professor of Medicine at the Abramson Cancer Center of the University of Pennsylvania, will deliver the BiovaxID presentation titled, “Idiotype Vaccine Therapy (BiovaxID) in Follicular Lymphoma in First Complete Remission: Phase III Clinical Trial Results.”

Pixantrone Phase 3 Data To Be Presented At The 2009 American Society Of Clinical Oncology (ASCO) Annual Meeting

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that data from CTI’s pivotal phase III EXTEND (PIX301) trial of pixantrone in patients with advanced, relapsed aggressive non-Hodgkin’s lymphoma (NHL) will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 29 to June 2, 2009 in Orlando, Florida.

Ruth Pettengell, M.D. of St. George’s Hospital, University of London, an investigator on the study, is scheduled to present the data on Monday, June 1, 2009 during the Lymphoma and Plasma Cell Disorders session that will be held from 2:00 PM-6:00 PM Eastern Time. The presentation, abstract #8523, is titled, “Randomized Phase III trial of pixantrone compared with other chemotherapeutic agents for third-line single-agent treatment of relapsed aggressive non-Hodgkin’s lymphoma.”

PROVENGE Significantly Prolongs Survival In Men With Advanced Prostate Cancer In Pivotal Phase 3 IMPACT Study

Mary Crowley Cancer Research Centers in Dallas, Texas announced that the pivotal Phase 3 IMPACT study of PROVENGE(R) (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study’s design. The safety profile of PROVENGE appeared to be consistent with prior trials. Mary Crowley is the local researcher in this trial.

Clinical Trial Exploring Use Of Cardiac Device In New Groups Of Heart Failure Patients Completes Enrollment Phase

Medtronic, Inc. (NYSE: MDT) announces completion of the enrollment phase of 1,800 patients in the RAFT clinical trial (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial), which is studying the impact of cardiac resynchronization therapy in mildly symptomatic heart failure patients, or those at risk of worsening heart failure, but not currently indicated under medical guidelines to receive treatment with the device.

“This study is important to guide therapy for heart failure patients with milder heart failure symptoms who have a dilated heart and poor heart function. These patients have a tendency to develop worsening symptoms, to require hospitalization, and they may die prematurely. This study will determine if cardiac resynchronization therapy, when used earlier in the disease, can delay or prevent the progression of heart failure,” said Anthony Tang, M.D., RAFT Nominated Principal Investigator and Adjunct Professor of Medicine, University of Ottawa.

PLx Pharma Receives $730,000 In Funding From U.S. Army In SBIR Phase II Award

PLx Pharma announced the award of a U.S. Army contract totaling $730,000 as part of the Army’s Small Business Innovation Research (SBIR) program. The award funds continued development of PL 4500, a molecular complex of indomethacin and phosphatidylcholine that is being developed as a GI safer anti-inflammatory and analgesic in both oral and IV formulations.

The Phase II award follows the successful completion of a Phase I program, in which PL 4500 was shown in in vivo and in vitro models to provide a longer period of analgesia with less GI toxicity than traditional indomethacin at standard doses while providing an equivalent degree of anti-inflammatory and analgesic efficacy. Such a GI-safer formulation of indomethacin could be used for the treatment of inflammation and pain due to trauma or surgery, while avoiding the sedative and addictive potential of opioid pain medications.

CyDex Pharmaceuticals Announces Successful Completion Of Phase II Clinical Trial For Budesonide/Azelastine Combination Solution Nasal Spray

CyDex Pharmaceuticals, Inc. announced that it has successfully completed an early proof-of-concept phase II clinical trial of its Captisol-Enabled budesonide/azelastine nasal spray for seasonal allergic rhinitis (SAR). CyDex has an international PCT patent application pending for this combination nasal spray product.

A Randomized, Double-Blind, Placebo-Controlled, Three-Way Cross-Over Study was conducted in 108 SAR patients to Compare the Relative Efficacy of Captisol-Enabled Budesonide + Azelastine Nasal Spray (Single Solution) and Rhinocort Aqua (Suspension) + Astelin Nasal Spray (Solution) against Placebo Nasal Spray Solution in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC).

Elan Clarifies Duration Of Bapineuzumab Phase 3 Trials

Elan Corporation, plc (NYSE: ELN) today clarified recent reports that the duration of the bapineuzumab Phase 3 clinical trials may be extended. The protocols for the four Phase 3 trials for bapineuzumab, which are approved by regulatory authorities, are designed for patients to participate for a duration of 18 months. The planned duration of the trials has not changed since the program was announced in December 2007. There are currently no plans to extend the duration of the Phase 3 trials.