Watch List for 6/13
Will be moving my blog here soon -
http://biotechtrader34.blogspot.com/2011/06/my-watchlist-for-week-of-613.html?spref=tw
$IMUC $AVII Phase 2 News for today
ImmunoCellular Therapeutics (OTC:IMUC) said Thursday it has expanded the number of sites for its phase two clinical trial of ICT-107, a potential vaccine treatment for brain cancer.
Originally, the trial, which is now underway, was planned to be held at up to 15 clinical centres, but this number has now been increased to 20 or more, the Los Angeles-based company said.
ImmunoCellular has qualified 21 sites so far, and has submitted the trial to 12 prospective sites’ Institutional Review Board #IRB# for approval. Of these 12 sites, six have now received their IRB approval.
The phase two study is a double-blind, placebo-controlled test to determine the safety and efficacy in patients with newly diagnosed glioblastoma multiforme, an aggressive type of brain tumour.
The vaccine uses cancer stem cells to target multiple tumour-associated antigens, which generate an antibody response from the body’s own immune system.
BOTHELL, WA–(Marketwire – Jun 9, 2011) – AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today provided an update on the initiation of its Phase 2 clinical trial of eteplirsen, the Company’s lead therapeutic candidate for the treatment of Duchenne muscular dystrophy (DMD#.
On June 8th, following a meeting of the Institutional Review Board #IRB# of Nationwide Children’s Hospital in Columbus, Ohio, the site of the Phase 2 clinical trial, AVI received an IRB request to modify the clinical trial protocol. AVI is reviewing the request, which is not related to the safety or expected activity of eteplirsen, and anticipates submitting a revised Phase 2 clinical trial protocol to the IRB later this month. The U.S. Food and Drug Administration #FDA) has not communicated any concerns regarding the original design of the Phase 2 clinical trial at this time and the Company intends to provide any updates on this protocol to the FDA.
“We will work quickly and deliberately to address the IRB’s request, and we expect to initiate the Phase 2 trial in the third quarter,” said Chris Garabedian, AVI’s President and CEO. “Furthermore, we are confident that we will remain on track in initiating a pivotal trial in the second half of 2012. We remain fully committed to eteplirsen development and its potential as an important treatment for DMD.”
via AVI BioPharma Provides Update on Initiation of Eteplirsen Phase 2 Clinical Trial.
$XOMA Announces Phase 2a Six-Month Top Line Trial Results Support Safety and Biological Activity Nasdaq:XOMA
XOMA Announces Phase 2a Six-Month Top Line Trial Results Support Safety and Biological ActivityBERKELEY, Calif., June 8, 2011 GLOBE NEWSWIRE — XOMA Ltd. Nasdaq:XOMA, a leader in the discovery and development of therapeutic antibodies, released six-month top line results from a Phase 2a clinical trial of XOMA 052 in 74 patients with Type 2 diabetes. The results were as expected based on data from the Phase 2a three-month interim review and the Phase 2b trial. XOMA 052 was well tolerated with no significant differences between the XOMA 052 and placebo groups in observations of adverse events. XOMA 052 continued to show evidence of biological activity as shown by a reduction in levels of C-reactive protein, a biomarker of cardiovascular risk. There were no differences in glycemic control between the drug groups and placebo as measured by hemoglobin A1c levels. This Phase 2a trial was designed as an exploratory trial focused on overall safety and kinetics and was not designed to show statistically significant differences in measures of biological activity.
$CLSN Announces DSMB Recommends Advancing DIGNITY Study of ThermoDox(R) Into Phase II
06/08/11 – Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that after reviewing safety data from the Company’s recently completed Phase I portion of the DIGNITY Phase I/II study of ThermoDox® and hyperthermia in recurrent chest wall (RCW# breast cancer #the DIGNITY Study#, an independent Drug Safety Monitoring Board #DSMB# has recommended advancing from Phase I to Phase II at 50 mg/m2 of ThermoDox®.
The DIGNITY Study is a multicenter, single-arm, open-label, potentially registrational trial enrolling up to 109 patients with RCW breast cancer. The study is designed to evaluate the potential for ThermoDox® in combination with hyperthermia to provide local control of superficial breast cancer recurrence. The primary endpoint is durable complete local response. The DIGNITY Study builds upon promising data from a Phase I dose escalation study conducted at the Duke University Medical Center, in which patients #n=16) demonstrated evidence of clinical activity, either stable disease, partial response or complete response. Toxicities are consistent with doxorubicin, the active agent in ThermoDox® and a widely used chemotherapeutic with a well established safety profile
$RXii Pharmaceuticals phase 2 results NeuVax
RXi Pharmaceuticals Corporation presented Phase 2 efficacy results for NeuVax in combination with trastuzumab (Herceptin; Genentech/Roche). RXi is developing NeuVax, a CD8 T-cell eliciting immunotherapy, for the adjuvant treatment of low to intermediate HER2 expressing breast cancer. Data from the E75 Phase 2 breast cancer trial and another CD8 T cell eliciting peptide were analyzed, and the control arms of each trial were combined for this analysis. Of 187 patients enrolled in the E75 trial, 108 received vaccine and 79 were in the control arm. Of the vaccine treated patients 15 received Tz. A total of 32 patients in the combined control arms received Tz (trastuzumab). The recurrance rate for the control arm was 12.5% (4/32), comparable with reported rates of similarly staged and treated patients. The recurrance rate for the NeuVax +Tz arm was 0% – no patients receiving vaccine after adjuvant Tz relapsed. A total of 30 patients were treated with Tz followed by vaccine, with zero patients recurring (0/30, p=0.06). NeuVax consists of the E75 peptide derived from HER2 combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months.
via RXi Pharmaceuticals Corp (RXII.O) Key Developments | Reuters.com.
$OXGN $PCYC Phase II news from 6/6/2011
SOUTH SAN FRANCISCO, Calif., June 6, 2011 (GLOBE NEWSWIRE) — OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that encouraging final results from a randomized, controlled, Phase 2/3 study of ZYBRESTAT (fosbretabulin tromethamine, or CA4P) in patients with anaplastic thyroid cancer (ATC) were presented today at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois, by Julie Sosa, M.D., Associate Professor of Surgery and of Medicine at Yale University, and primary investigator in the study.
SUNNYVALE, Calif., June 6, 2011 /PRNewswire/ — Pharmacyclics, Inc. (Nasdaq: PCYC) today announced data from the oral presentation of the Phase IB/II study of the Btk inhibitor, PCI-32765, in chronic lymphocytic leukemia / small cell lymphocytic lymphoma (CLL/SLL) at the 2011 American Society of Clinical Oncology Annual Meeting. The company will also provide a clinical development program update for the Btk Inhibitor, PCI-32765. The update will include 1) efficacy from the Phase IA trial of PCI-32765 in B-cell malignancies including mantle cell lymphoma, follicular lymphoma and diffuse large B-cell lymphoma and 2) a status update for ongoing PCI-32765 clinical studies, and 3) an update on future clinical trials including program expansion opportunities in follicular lymphoma and multiple myeloma. The company will also provide information on the Non-Hodgkins Lymphoma (NHL) market. An investor conference call to discuss the clinical trial results and other company updates will be hosted today at 4:30pm ET, further information is provided below. Slide presentations will be posted on the Pharmacyclics website including the ASCO presentation of the Phase IB/II study results and the Investor Relations presentation.
$GXTI $ARIA $RPTP Phase 3 News
GTx, Inc. (Nasdaq: GTXI) has reached an agreement with the U.S. FDA in regard to design of two Ostarine™ registration Phase IIIs in patients with on-small cell lung cancer (NSCLC).
In July, GTx will initiate the Ostarine POWER1 and POWER2 (Prevention And Treatment Of Muscle Wasting in CancER) Phase III clinical trials and, assuming enrollment for both studies is completed within one year, expects completion of the two five month studies (last patient last visit) in Q412.
WHITEHOUSE STATION, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merck (NYSE:MRK), known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA), today announced the presentation of detailed results from the Phase III SUCCEED clinical trial. SUCCEED evaluated oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. In this patient population, ridaforolimus improved progression-free survival (PFS) compared to placebo, the primary endpoint of the study. The complete study results were presented by Sant P. Chawla, M.D., director, Sarcoma Oncology Center, Santa Monica, CA, during the 2011 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
NOVATO, Calif., June 6, 2011 (GLOBE NEWSWIRE) — Raptor Pharmaceutical Corp. (“Raptor” or the “Company”) (Nasdaq:RPTP), today announced that on June 3 the last clinical trial patient visits were completed and final data analysis will commence this week on the Phase 3 clinical trial of its delayed-release oral formulation of cysteamine bitartrate (“DR Cysteamine”) in patients with nephropathic cystinosis (“cystinosis”). The Company announced that 41 patients have completed the nine-week study protocol and the Company expects to report the data from this trial by the end of July 2011. The extension phase of the clinical trial, in which all patients completing the Phase 3 study may elect to continue on DR Cysteamine therapy, is ongoing.
Data From Trial Expected to be Released July 2011
$RXII $ECYT $VICL Phase 2 News
WORCESTER, Mass.–(BUSINESS WIRE)–RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, announced updated data from its Phase 2 clinical trial of NeuVax™ at the American Society of Clinical Oncology (ASCO) annual meeting. RXi is developing NeuVax for the adjuvant treatment of low to intermediate HER2 expressing breast cancer.
The NeuVax Phase 2 trials enrolled 182 patients, including node positive and node negative, HER2 1+, 2+ and 3+ patients. All patients received standard of care (SoC) therapy and were confirmed to be disease-free prior to enrollment. Following enrollment, eligible patients were administered the NeuVax vaccine once a month for six months, followed by booster shots one every 6 months thereafter. The efficacy endpoint for the trial was disease free survival (DFS), the same endpoint in the FDA approved SPA (Special Protocol Assessment) for the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study.
… Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study expected to initiate in 1H 2012 under FDA approved Special Protocol Assessment (SPA)
WEST LAFAYETTE, Ind., June 5, 2011 (GLOBE NEWSWIRE) – Endocyte, Inc., (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced that the Phase 2 PRECEDENT trial, investigating the company’s lead drug candidate, EC145, in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant ovarian cancer, met its primary endpoint by showing an 85 percent, 2.3 month, improvement in median progression-free survival (PFS) in the intent-to-treat population and a 260 percent, 4.0 month, improvement in a subset of folate receptor positive patients. EC145 in combination with PLD showed limited additional toxicity compared to standard therapy with PLD alone. The most commonly occurring adverse events were neutropenia, small intestine obstruction, and palmar-plantar erythrodysesthesia. EC145 is a therapeutic that targets the folate receptor and EC20 is a companion imaging diagnostic used to assess folate receptor presence.
CHICAGO, June 6, 2011 (GLOBE NEWSWIRE) — Vical Incorporated (Nasdaq:VICL) today announced results from new statistical analyses of data from three previously completed clinical trials of the company’s Allovectin® immunotherapy in patients with metastatic melanoma, showing with strong positive correlation that responders lived significantly longer than nonresponders. In a Phase 2 study of high-dose (2 mg) Allovectin® in 127 chemo-refractory or chemo-intolerant patients with metastatic melanoma, the overall survival was 65% at one year, 43% at two years, and 32% at three years. The median overall survival was 18.8 months (95% CI: 14.8 – 26.2 months). Survival among the 15 clinical responders ranged from 18 months to more than seven years (median survival not reached; 95% CI: 35.5 months – not reached). The median overall survival for nonresponders in the Phase 2 study was 16.2 months (95% CI: 13.3 – 21.2 months), which is notably longer than historical survival for other metastatic melanoma treatments, suggesting that these patients also may have derived clinical benefit from Allovectin®.
http://tinyurl.com/3lxzllq
$SNTA, $OXGN, $NKTR $PPHM – Phase 2 News
LEXINGTON, Mass.–(BUSINESS WIRE)–Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today presented results at the Annual Meeting of the American Society for Clinical Oncology (ASCO) from a Phase 2 single agent clinical trial of ganetespib in advanced non-small cell lung cancer (NSCLC) that showed promising clinical activity in patients with progressive disease. Ganetespib is a potent inhibitor of heat shock protein 90 (Hsp90) currently being studied in a broad range of clinical trials with approximately 400 patients treated to date. Ganetespib is structurally unrelated to earlier Hsp90 inhibitors such as 17-AAG
SOUTH SAN FRANCISCO, Calif., June 4, 2011 (GLOBE NEWSWIRE) — OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it presented updated safety and clinical activity data from the FALCON trial, a stratified randomized, controlled Phase 2 study of ZYBRESTAT™ (fosbretabulin tromethamine, or CA4P) in patients with non-small cell lung cancer (NSCLC), at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. The data were presented in a poster by Edward Garon, M.D., Assistant Professor of Medicine at the University of California, Los Angeles and primary investigator in the study.
CHICAGO and SAN FRANCISCO, June 4, 2011 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR) today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 as a second- and third-line treatment in patients with metastatic breast cancer during the 2011 American Society of Clinical Oncology Meeting (ASCO). NKTR-102, a next-generation topoisomerase I inhibitor, is Nektar’s lead oncology drug candidate and is being evaluated in multiple cancer indications. The randomized Simon two-stage study presented at ASCO evaluated two 145 mg/m2 dose schedules of single-agent NKTR-102, every two weeks (q14d) and every three weeks (q21d), in 70 metastatic breast cancer patients who failed a prior taxane therapy. Eighty-nine percent (62/70) of patients in the study received a prior anthracycline/taxane with or without capecitabine.
TUSTIN, CA and CHICAGO, IL–(Marketwire – Jun 3, 2011) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today is presenting data from a Phase II trial of Cotara® in recurrent glioblastoma multiforme (GBM) at an oral poster discussion at 5:00 PM CDT at the Annual Meeting of the American Society of Clinical Oncology (ASCO). In 41 patients treated at first relapse with a single infusion of Cotara, interim median overall survival (MOS) is 8.8 months (38 weeks). Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single-infusion therapy directly into the tumor, destroying the tumor from the inside out, with minimal exposure to healthy tissue.
$OREX – Schedules June 3, 2011 Webcast and Conference Call to Provide a Regulatory Update on Contrave
SAN DIEGO, June 1, 2011 /PRNewswire/ — Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, will announce a regulatory update on Friday, June 3, 2011 before the markets open. The announcement will be followed by a live webcast and conference call at 8:00 a.m. Eastern time.
Orexigen management will host the call and webcast to discuss this update. The live call may be accessed by phone by calling (866) 730-5771 (domestic) or (857) 350-1595 (international), participant code 27244834. The webcast can be accessed live on the investor relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.
