Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Cell Therapeutics (CTIC): As previously announced in late February, CTIC is closing its Italian operations starting Monday 5/18 and has reached an agreement with the employee union on a severance package. The agreement relates to a reduction of the Company's total headcount in Italy by 56 positions in the immediate months and is expected to save CTI approximately $14 million in annual operating expenses.
CTIC will also present pivotal Phase 3 EXTEND (PIX301) clinical trial data for pixantrone in patients with advanced, relapsed aggressive non-Hodgkin's lymphoma (NHL) 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.
CTIC expects to complete the submission of a New Drug Application (NDA) for pixantrone during 2Q09 and will request priority review which, if granted, could lead to an approval decision from the FDA before year-end.
CuraGen (CRGN): At the end of 1Q09, CRGN had $80M of cash/investments on hand (with expected cash burn of $3-4M during 2Q09 to fund operations) along with a Phase 2 anti-cancer compound (CR011) that continues to show promising activity in metastatic melanoma and early activity in breast cancer. CRGN has debt of $14M (2011 notes outstanding) and a market cap of just $58M, resulting in a negative enterprise value of ($8M) for the Company.
In February, CRGN announced a review of strategic alternatives that could enhance shareholder value, which may result in any or none of the following outcomes: (1) selling or licensing CR011, (2) acquiring additional assets or business lines, or (3) selling the company. CRGN expects to report final results of its Phase 2 melanoma trial and initial results of its breast cancer trial at ASCO. A summary of these trials is provided at this link, which summarizes the Company's most recent SEC 10-Q filing.
CR011 is an antibody-drug combination comprised of CR011, a fully-human monoclonal antibody resulting from our collaboration with Amgen (AMGN) Fremont linked to a compound known as monomethylauristatin E, or vcMMAE, using technology licensed from Seattle Genetics (SGEN). CR011 targets a specific molecule located on the surface of cancer cells called glycoprotein NMB, or GPNMB. After the antibody-drug conjugate (CR011-vcMMAE) binds to this target protein, it is transported inside the cancer cell where vcMMAE is separated from the antibody and causes cancer cell death.
Allos Therapeutics (ALTH) announced last week that updated data from its pivotal Phase 2 PROPEL study of pralatrexate (PDX) in patients with relapsed or refractory peripheral T-cell lymphoma will be presented at ASCO on 5/30/09. The final results from the PROPEL study were reported in early February and formed the basis of the Company’s NDA filing for FDA approval in March 2009. The poster presentation at ASCO will include analyses of response rate and durability of response, as well as overall survival.
On 5/11/09, Immunomedics (IMMU) provided the following updates for its clinical development pipeline.
UCB SA (OTC:UCBJF) has completed patient enrollment for their Phase 2b study of epratuzumab in lupus with results expected during 3Q09 calendar year (which is 1Q10 for IMMU fiscal year). The North Central Cancer Treatment Group plans to report final results from its Phase 2 study of epratuzumab with rituximab and chemotherapy in patients with aggressive lymphoma in an ora presentation at ASCO on 5/30/09.
Nycomed (privately held) is expected to initiate a Phase 2 study of subcutaneous veltuzumab in patients with rheumatoid arthritis during 3Q09 calendar year (which is 1Q10 for IMMU fiscal year). Data from a Phase 1 study of subcutaneous veltuzumab in B-cell malignancies will be presented in a poster session at ASCO on 6/1/09.
Yttrium-90-labeled hPAM4 was granted Fast Track designation for the treatment of patients with pancreatic cancer. Results from Phase 1b study in advanced pancreatic cancer patients will be presented in a poster session at ASCO on 5/31/09. Updated results from the dose-escalation trial of milatuzumab in patients with multiple myeloma will be presented in a poster session at ASCO on 5/30/09.
T-DM1: This TAP compound comprises ImmunoGen's DM1 cell-killing agent linked to the HER2-binding antibody, trastuzumab. It is in development by Roche (OTCQX:RHHBY) through its acquisition of Genentech. Patient enrollment was completed in March 2009 in the Phase 2 trial evaluating T-DM1 as a third-line treatment for HER2-positive metastatic breast cancer. Enrollment in this 100-patient, multi-center study began in July 2008. Genentech expects final study data by 1Q10 and has stated that, if the data from this study are compelling, it will discuss an earlier approval path with the FDA. Final results from the 100-patient "second-line plus" Phase 2 trial for T-DM1 will be reported at the upcoming ASCO annual meeting.
IMGN242: This ImmunoGen anticancer compound is in Phase 2 testing for the treatment of CanAg-expressing gastric cancer that failed first-line treatment. Early data from this trial will be reported in an abstract at the ASCO annual meeting and IMGN expects to determine in 2009 whether this study will be expanded or concluded.
Roche: Roche recently provided an overview of results from studies that further the Company’s approach to developing targeted medicines for people with cancer, a diagnosis that will affect more than one in three people during their lifetime. Results from studies involving the company’s approved and investigational treatments will be presented at ASCO. Click here for two video reports associated with this article at BioMedReports.com.
- Advances in HER2-targeted therapy: Positive Phase 3 study results for Herceptin in advanced HER2-positive stomach cancer and encouraging Phase 2 data in metastatic HER2-positive breast cancer with the novel treatment trastuzumab-DM1 (T-DM1) that uses the Herceptin antibody to deliver a specialised cancer cell-killing agent to tumour cells.
- New approaches to treating lung cancer: Positive Phase 3 studies of Avastin and Tarceva as first-line maintenance treatments in advanced non-small cell lung cancer (NSCLC), including important information about biomarkers in lung cancer.
- Avastin in early-stage colon cancer: Full results on the first Phase 3 study (C-08).
- Personalizing cancer treatment: encouraging early data for Roche’s targeted BRAF inhibitor in malignant melanoma.
- Combined Roche and Genentech oncology pipeline: includes 27 investigational agents in clinical studies.
Disclosure: No positions.