written by reader Biotech Traders thread

By alanh, April 16, 2015

Many of the comments on the main bio threads are about day to day trading activity. This thread has been created so as to cut down the quantity of posts on the main bio threads, plus give traders their own space to bat stuff around. There is no thread leader as the thoughts are momentary. So it works like a ticker tape as do the SP’s.
Enjoy
PS Anyone use Candlesticks?

This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.

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SoGiAm
5 years ago

ARWR- Arrowhead Reports Peak Reduction in HBsAg of Up to 99% (1.9 log) After a Single Dose with Hepatitis B Candidate ARC-520 in Treatment Naïve Cohort of Phase 2a Study

– Single-dose Reductions in HBeAg of up to 98% (1.7 log) also achieved

– Multi-dose studies in chimpanzees showed peak reduction in HBsAg of up to 99.8% (2.7 log)

– Company hosts an analyst and investor day today to discuss results

PASADENA, Calif.–(BUSINESS WIRE)– Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, is hosting an analyst day today in New York, with a presentation starting at 11:00 a.m. EDT to discuss top-line findings from the Heparc-2001 Phase 2a clinical study of ARC-520, its candidate for the treatment of chronic hepatitis B infection. Additionally, the company will discuss findings from a study of 9 chimpanzees that have been treated monthly with ARC-520 for between 6 and 11 months with a background therapy of nucleotide/nucleoside analog inhibitors (NUCs) tenofovir and/or entecavir.

Key findings:

Arrowhead’s proprietary DPC™ platform can effectively and consistently knock down target genes in humans
HBV E-antigen positive (HBeAg-positive) patients on a background of chronic entecavir receiving a 4 mg/kg single-dose of ARC-520 showed a mean maximal 92% (1.2 log) reduction in circulating HBeAg and a best reduction of 98% (1.7 log). Similar mean maximal reductions were also demonstrated in HBV core-related antigen (HBcrAg) from both HBeAg-negative and -positive patients. ARC-520 is designed to silence all gene products expressed by HBV cccDNA, so this data suggests that it may be substantially disrupting additional viral functions.

ARC-520 achieves significant HBV s-Antigen (HBsAg) reductions in humans, particularly in treatment naïve, HBeAg-positive patients
In a cohort of NUC-naïve, HBeAg-positive patients, best peak HBsAg reduction has been 99% (1.9 log) and the mean maximum HBsAg reduction has been 1.05 log through 15 days post ARC-520 treatment. This open-label cohort is fully enrolled; data collection is ongoing and will be continued through Day 85 post ARC-520 treatment. These reductions are substantially higher than results from NUC treatment-experienced cohorts.

Arrowhead identifies a large target HBV population for ARC-520 and describes a new paradigm for the HBV lifecycle
Arrowhead’s long-term chimp study and findings from the clinical study suggest that HBV cccDNA decreases during the HBV lifecycle, especially with the transition from HBeAg-positive to -negative. HBV DNA integrated into host DNA appears to maintain significant HBsAg production as cccDNA declines. This process is accelerated with NUC treatment. ARC-520 specifically targets cccDNA, and NUC-naïve HBeAg-positive patients are expected to be richest in cccDNA. It is estimated in the U.S. that 95% of people chronically infected with HBV are currently NUC-naïve and at least 50% of them are likely to be HBeAg-positive. While it is unknown what impact ARC-520’s broad based effects on HBV biology will have on the sero-clearance process in any of the HBV subgroups, the effect on HBsAg in NUC-naïve HBeAg-positive patients makes this group especially attractive to study and a key focus for multi-dose studies going forward.

ARC-520 induces deep HBsAg reduction in chronically HBV infected chimps and 1 of 4 HBeAg-positive chimps demonstrated signs of immune reactivation during therapy
9 chimps were first suppressed with NUCs and then treated with 6 – 11 monthly doses of ARC-520. 4 HBeAg-positive chimps demonstrated 99% (2 log) mean peak reduction in HBsAg, and 1 of the 4 experienced signs of immune reactivation during therapy; 4 HBeAg-negative chimps demonstrated 81% (0.7 log) mean peak reduction in HBsAg; and 1 chimp transitioning from HBeAg-positive to HBeAg-negative demonstrated peak HBsAg reduction of 87% (0.9 log).

ARC-520 has been well tolerated
84 humans have received ARC-520 and to date no adverse events have been rated as serious or severe, no discontinuations have occurred due to an adverse event, and no laboratory results have indicated any end organ toxicity. Additionally, 9 chimps received 6-11 monthly doses of ARC-520 and no safety signals were detected in any chimp.

Arrowhead expands its HBV portfolio by nominating an additional clinical candidate that is complementary to ARC-520
ARC-520 will continue development including focus on the significant market of e-antigen positive treatment-naïve chronic HBV patients. ARC-521 is being developed to target cccDNA and also, integrated DNA, which appears to be a more significant producer of HBsAg in patients who have been treated with NUCs or who are e-antigen negative. In HBeAg-negative chimps predicted to have higher levels of integrated DNA, administration of the integrant-targeted siRNA in ARC-521 led to 99% (2 logs) of additional HBsAg reduction. The Company expects to file an IND or equivalent for ARC-521 by mid-2016.

Quotes:

Christopher Anzalone, Ph.D., president and CEO of Arrowhead, said, “These are exciting data that represent a significant leap forward for our DPC™ platform, ARC-520, and the HBV field. We have achieved the highest knockdown ever reported in humans with RNAi and a safety profile that continues to be excellent. We are optimistic that this will ultimately translate into powerful clinical outcomes for ARC-520 and follow-on candidates against multiple indications.”

Robert Gish, M.D., clinical professor of medicine (consultant) at Stanford Hospital and Medical Center, said, “These animal and single-dose human studies with ARC-520 in chronic hepatitis B infected individuals provide compelling evidence about a multi-pronged antiviral effect that will accelerate new studies with multiple doses and combination therapy to move forward.”

Robert Lanford, Ph.D., director at the Southwest National Primate Research Center, said, “I have been extremely impressed by the potency of ARC-520 and its ability to reduce multiple viral proteins. The results from the study in chimpanzees have revealed some important new insights about HBV biology and have introduced new ideas about effective ways to intervene in the HBV lifecycle.”

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nocitons
nocitons
5 years ago
Reply to  SoGiAm

Oh yes. ARWR. Up 22% pre market. <3

Noci

👍 459
SoGiAm
5 years ago
Reply to  SoGiAm

ABUS- Watch on ARWR news per S Manian
ARWR- per Bio Boy Scout Multiple 45+ PT anticipated and Major T/O tgt LONG ZKSS, ARWR Best2ALL-Ben

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SoGiAm
5 years ago
Reply to  SoGiAm

Benzinga’s Top #PreMarket Gainers
8:08 am ET September 24, 2015 (Benzinga) Print
Conatus Pharmaceuticals Inc (NASDAQ: CNAT) shares rose 25.44 percent to $7.20 in pre-market trading after the company reported top-line results from Multicenter Phase 2 Portal Hypertension clinical trial in patients with liver cirrhosis.

Arrowhead Research Corp (NASDAQ: ARWR) shares rose 22.55 percent to $8.26 in pre-market trading following announcement of results of ARC-520 Hep B study.

Keryx Biopharmaceuticals (NASDAQ: KERX) shares climbed 19.64 percent to $4.69 in pre-market trading following announcement of the EU approval for Fexericx for the treatment of hyperphosphatemia in adults with chronic kidney disease.

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SoGiAm
5 years ago

CPXX- Celator(R) Pharmaceuticals Announces Positive Results from R&D Programs

8:00 am ET September 24, 2015 (PR Newswire) Print
Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, announced their successful R&D efforts to apply the CombiPlex(R) technology platform to optimize the efficacy of anticancer drug combinations incorporating molecularly targeted agents (MTAs).

CombiPlex is Celator’s proprietary technology that aims to address several of the fundamental shortcomings of conventional combination regimens, as well as the inherent challenges in combination drug development. Celator is applying this technology to create new drug combinations that target pathways associated with tumor cell growth and/or resistance to treatment. Such MTAs are being widely pursued with an increasing focus on combining agents that target multiple cellular pathways in order to improve therapeutic responses.

“While there have been promising signs of activity for certain molecularly targeted agents, it is clear that combinations will be required for optimal efficacy,” said Dr. Joseph Bertino, chief scientific officer at Rutgers Cancer Institute of New Jersey and chairman of Celator’s Scientific Advisory Board. “In addition, many combinations will require simultaneous exposure and attempts to accomplish this to date have often led to toxicity problems.”

CombiPlex is well positioned to address the challenges with the development of combination drug candidates. Nano-scale delivery systems coordinate the pharmacokinetics (PK) of drug combinations after administration so that the optimal ratio of the two drugs is exposed to tumor cells for prolonged times while reducing drug exposure and toxicity to normal tissues.

Recent results from preclinical studies conducted by Celator suggest the technology may significantly improve the therapeutic index of combinations containing MTAs. Celator’s efforts have focused on two combinations: the heat shock protein 90 inhibitor AUY922 combined with docetaxel and the MEK inhibitor selumetinib combined with the Akt inhibitor ipatasertib. In both cases, the drug combinations were stably co-formulated in Celator’s proprietary hydrophobic prodrug nanoparticle delivery systems which provided well-coordinated plasma concentrations over 24 hours that were orders of magnitude higher than observed for the free drug combinations. Free drug combinations refer to the drugs as they are currently administered; individual drugs administered in combination without regard to their ratio dependent interaction. In addition, whereas combined treatment with the free drugs required marked dose reductions due to toxicity, the nanoparticle formulations could be administered at higher doses.

For both combinations, the CombiPlex formulations provided significant improvements in efficacy over the free drugs in human xenograft tumor models including breast, colorectal and ovarian. Furthermore, there was evidence of strong drug ratio-dependent efficacy and in vivo synergy.

Another benefit observed during this research was the versatility and modular nature of the nanoparticle technology. Once formulation conditions were optimized for the two initial combinations, the drug components could be “mixed and matched,” rapidly generating additional CombiPlex products with coordinated PK. This versatility was then taken one step further by generating a 3-drug combination, co-formulating selumetinib, AUY922 and docetaxel into a single hydrophobic prodrug nanoparticle.

The data have been accepted for presentation at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held in Boston, MA November 5-9. Long ZKSS, CPXX -Ben

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SoGiAm
4 years ago

IHUB Most read $TALK and Breakout board $TITXF #OTCBB https://t.co/gyA6Fii0v8

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SoGiAm
4 years ago

ARNI-I noticed this equity moved up 70% yesterday. I believe it was the result of 1/13/15 financing and subsequent Insider buying of appx 2.5M shares Best-Ben

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SoGiAm
4 years ago

EYEG-Wainwright PT $10

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SoGiAm
4 years ago
Reply to  SoGiAm

EYEG- http://www.eyegatepharma.com/investors/sec-filings/
Presentation: 01/19/2016 8-K Report of unscheduled material events or corporate event Current Reports DOC PDF

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gambly1
gambly1
4 years ago

Cool! I found a trader thread. will keep my comments here.

Long 23K shares of ZFGN 6.55… feb 9 conf coming up. Usually I’d go alot bigger here (was looking for 75k shares) but I’ll keep it relatively small.

IMO longs from 12 have puked up most of their shares.

g

👍 142
gambly1
gambly1
4 years ago
Reply to  gambly1

Essentially the trade rationale here is that the Feb 9 conf may be where they present the obesity data. Looking at how the stock reacted with the PWS data, the pps may react 30-50% on good obesity data. Judging by the prior p-values, IMO the p-value here will be around 0.001 or even better… plus when they announce the path forward (imo anticoagulation for PWS/belo?) I see a gap up.

g

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SoGiAm
4 years ago
Reply to  gambly1

ZFGN- Yeah! Thanks gamby1 🙂
CDNL- Penny 4 your thoughts? Best2You-Ben

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