glad to note blackrock renewed focus on ATRS
see also blackrock Inc's huge CHTP add to large present position in several Blackrock family funds.
Feb.14 catalyst and 2nd positive adcom ( overwhelming suport this last ... )
The CTC conversion rate (5 or more to less than 5) was approximately 80% in pts with low NE markers. Prior cabazitaxel or abiraterone and/or enzalutamide did not appear to affect response. Centralized assessments of images by RECIST of all pts are currently planned and will be presented. Conclusions: PSMA ADC at 2.3 mg/kg was generally well tolerated in pts with progressive mCRPC previously treated with taxane. Anti-tumor activity, CTC and PSA reductions were observed at 2.3 and 2.5 mg/kg. Updated safety, tumor response and radiographic assessments from the full cohorts of 2.3 and 2.5 mg/kg will be presented. Testing in taxane naïve pts is also ongoing. Clinical trial information:
A phase II trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC).
Background: The abundant expression of prostate-specific membrane antigen (PSMA) on prostate cancer cells provides a rationale for antibody therapy. PSMA antibody drug conjugate (ADC) is a fully human antibody to PSMA linked to the microtubule disrupting agent monomethyl auristatin E (MMAE). It binds PSMA and is internalized and cleaved by lysosomal enzymes releasing free MMAE causing cell cycle arrest and apoptosis. We enrolled 70 patients (pts) in a phase II trial of PSMA ADC in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC). Methods: Pts with progressive mCRPC following taxane and ECOG PS 0 or 1 were eligible. PSMA ADC was administered Q3 week IV for up to eight cycles. Safety, tumor response by prostate-specific antigen (PSA), circulating tumor cells (CTC), imaging, biomarkers and clinical progression were assessed. Dosing was initiated at 2.5 mg/kg and adjustment for tolerability was allowed. Results: Thirty five pts began treatment at 2.5 mg/kg. Due to neutropenia, the remaining 35 pts began at 2.3 mg/kg. All pts received prior docetaxel and abiraterone and/or enzalutamide. Forty one percent also received cabazitaxel. Adverse events (AEs) were consistent with what was seen in phase I; most common significant AEs were neutropenia (grade 4, 6.7% and 11.4% at 2.3 and 2.5 mg/kg, respectively) and peripheral neuropathy (grade 3 or higher, 6.7% (2.3) and 5.7% (2.5)). Two pts at 2.5 mg/kg died of sepsis. 43% of pts at 2.3 and 37% of pts at 2.5 had declines in CTC from 5 or more to less than 5 cells/7.5 ml blood and 57.1% (2.3) and 74.1% (2.5) had 50% or more CTC declines; 26.1% (2.3) and 16.1% (2.5) had PSA declines of 30% or more thus far. PSA and CTC responses were associated with higher PSMA expression on CTC and lower neuroendocrine (NE) markers.
A phase II study of 99mTc-trofolastat (MIP-1404) SPECT/CT to identify and localize prostate cancer in high-risk patients undergoing radical prostatectomy (RP) and extended pelvic lymph node dissection (EPLND) compared to histopathology: An interim analysis.
Background: Technetium (Tc99m) trofolastat (USANC) is a novel urea-based small molecule SPECT radiotracer with utility in imaging overexpression of PSMA in prostate cancer (PCa). Unlike earlier agents targeting PSMA, this ligand is rapidly internalized and retained in tumors. We conducted an open-label, multicenter phase 2 study in the US and Europe (NCT01667536). An interim analysis was performed at approximately 50% accrual. Methods: Patients (pts) with confirmed adenocarcinoma of the prostate scheduled for RP with EPLND at high risk for disease outside of the prostate gland were eligible. High risk pts were ≥cT3 or Kattan nomogram score ≥130. Within 30 days of screening, pts required a bone scan and pelvic MRI. After enrollment, pts received trofolastat followed by whole-body planar and SPECT/CT imaging 3 to 6 hrs later. Pts then underwent RP with EPLND within 21 days. SPECT/CT images were evaluated centrally by 3 readers blinded to clinical information and compared to on-site pathology assessments using a common scoring template. The primary endpoint was the ability of trofolastat to detect PCa within the gland. Secondary endpoints included detection of extent and location within the gland, pelvic lymph nodes and comparative performance against MRI. Results: 84 pts were enrolled to date from 16 centers. Interim data is available for 54 pts. A majority (≥2/3) of SPECT/CT readers correctly identified the presence or absence of primary PCa in 51/54 (94%, 85-98 95% CI) patients including 2 true-negative cases treated with neoadjuvant enzalutamide. Sensitivity and specificity were 94% (84-98 95% CI) and 100% (34-100 95% CI) respectively. Conclusions: Based on the interim data available, trofolastat has
looks to me like the trend is secure ... still. Sometimes I sell the News (I didn't today) but I certainly don't sell the Flop on Good News (added, actually, some too early, some right on time ie late).
Without the massive share swap the moment of PR, that of course fizzled, the volume today was middling.
Just more proof that things are proceeding well for SC / big pharma projects, and more will pop up.
Pretty astounding but got a tiger by the tail here and not upset that it coughed up a hair ball today. Not going to disturb my weekend.
Final NICE approval would open the door for Roche to a market of 13,000 people in the UK who currently have no recommended treatment option for GPA and MPA.
source - pmlive website, 24th January 2014
final draft guidance from the Nat Inst Health and Care Excellence recommends Mabthera for use on the NHS to treat GPA and MPA
Panic ( verb, noun) - replying to your own posts . ie "shytingdragon attacked the rumor in a panic, ignoring the fact that ARIA will soon move into the gap."
well ignoring the 300K ramp 15 minutes into end of day, hmm what about the 97K block reported exactly at close ... and a penny off HOB
Technically maybe. The shares were 'held' before en masse. I agree the Co was not diluted ... nor was the Co's cash enriched by the the sale. However retail is being diluted. Outstanding v. Float sort of thing. Same effect. And you better believe $12 shares from last month are for sale at $23.
Here comes the flurry , keep up on it while you still can ... willing to be a lot of new sellers are note bound by the disclosure requirements so, a lot of it will be stealth... enjoy
"so far" isn't "very" ..
think about it bud, why would this near double ... from a dilution that didn't even bolster Co coffers? I hope your strings are new & tuned cos you are about to get Played BigTime.
Even TheStreet is pumping this now, for "improving" results that do not merit 60% of the current market cap. Best luck. We longs have done well. Now get the heII out of Dodge