(Nasdaq:PPHMP), today announced the peer-reviewed publication of clinical data from a Phase I investigator-sponsored trial evaluating the company's lead investigational immunotherapy bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer. The manuscript details the results of the Phase I trial showing that the combination produced an objective tumor response in 85% of patients, including 15% of these patients achieving a complete response, measured in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
"The publication of these data marks an important milestone in the development of this novel therapeutic in a difficult to treat patient population," said Alison Stopeck, M.D., the principal investigator on the trial and Professor, Department of Medicine and Associate Director for Translational Research at the Stony Brook Cancer Center in Stony Brook, New York. "The regimen was very well tolerated and the clinical responses were encouraging. The data also suggest bavituximab may uniquely affect the coagulation system in a beneficial way for cancer patients. It is my belief that the combination of bavituximab with weekly paclitaxel is a feasible regimen that is associated with a promising response rate in patients with metastatic breast cancer and warrants further clinical exploration."
In the online released manuscript, researchers at the University of Arizona Medical Center led by Alison Stopeck, M.D. enrolled 14 patients with metastatic breast cancer (MBC) and while all were evaluable for toxicity, 13 were evaluable for response and progression free survival (PFS). These patients with HER2-negative MBC were treated with paclitaxel (80 mg/m2) weekly for three weeks of each four-week cycle and bavituximab (3 mg/kg) administered weekly beginning on day 15 after two weekly doses of paclitaxel. Results from 13 evaluable patients showed that 11 patients (85%) achieved an objective response, including two patients (15%) that achieved a complete response (CR), 9 patients with partial responses (PR) and 2 patients with progressive disease (PD). Median PFS for the combination of bavituximab with weekly paclitaxel was 7.3 months. In addition, the combination of bavituximab and paclitaxel was safe and well-tolerated with the majority of grade 1 or 2 adverse events being paclitaxel related. Approximately half of these patients were classified as "triple negative," a traditionally difficult-to-treat patient population. In addition, treatment with bavituximab reduced circulating PS-expressing microparticles (exosomes) which are immunosuppressive.
"These compelling results in a very difficult to treat patient population provide the foundation to move with confidence into a later stage trial," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. "These data build upon our historical clinical experience in the area of breast cancer and when combined with recent preclinical data demonstrating bavituximab's ability to promote antitumor immune activity, increase our understanding of the immune-stimulatory aspects of bavituximab."
These results appear in the March issue of the peer-reviewed journal, Cancer Medicine, in a manuscript titled: "A Phase I Clinical Trial of Bavituximab and Paclitaxel in Patients with HER-2 Negative Metastatic Breast Cancer."
The online article is available at: http://onlinelibrary.wiley.com/doi/10.1002/cam4.447/full
CORAL GABLES, FL / ACCESSWIRE / March 26, 2015 / In a March 25 Press Release, World Wrestling Entertainment (WWE) announced that it has initiated a joint venture with Authentic Brands Group, LLC, to make TapouT brand the official fitness and training partner of WWE.
This venture will be integrated with many WWE events and shows. According to the press, these include TV programming, WWE Network, pay-per-view broadcasts, live events, digital, and social media.
WWE Chairman & CEO Vince McMahon stated, "This joint venture aligns with our strategic approach, and we look forward to building the Tapout brand."
Also in line with TapouT brands, Axxess Pharma Inc. (AXXE) through its wholly owned subsidiary, AllStar Health Brands, Inc., signed exclusive licensing agreements to sell TapouT branded health supplements including vitamins, protein powder, as well as muscle building & muscle recovery supplements.
Recently, Axxess announced that it had presented the full TapouT line of products at the nation's largest health and fitness expo, "The Arnold Fitness Expo". Dr. Bagi, President of Axxess Pharma, stated, "This is part of our aggressive global marketing initiative. We anticipate 2015 will be our break out year in terms of global revenue generation and mass marketing
By a News Reporter-Staff News Editor at Pharma Business Week -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) and Baxter International Inc. (NYSE:BAX) announced positive top-line results for the primary endpoint from PERSIST-1, the randomized, controlled Phase 3 registration clinical trial examining pacritinib, a next generation oral JAK2/FLT3 multikinase inhibitor, for the treatment of patients with primary or secondary myelofibrosis. The PERSIST-1 trial met its primary endpoint in the intent-to-treat population with statistically significant activity observed in patients irrespective of their initial platelet count, including patients with very low platelet counts at study entry, a condition known as severe or life-threatening thrombocytopenia (see also CTI BioPharma Corp.).
The primary endpoint of the trial was the proportion of patients achieving a 35 percent or greater reduction in spleen volume from baseline to Week 24 as measured by magnetic resonance imaging (MRI) or computerized tomography (CT) when compared with physician-specified best available therapy (BAT), excluding treatment with JAK2 inhibitors. The PERSIST-1 trial demonstrated that pacritinib treatment provided a clinically and statistically significant response rate (p = 0.0003) in spleen volume reduction in patients with myelofibrosis when compared to BAT. Importantly, the trial results also demonstrated a significant difference among patients with platelet counts of less than 100,000 per microliter and less than 50,000 per microliter, both subgroups that were stratified at randomization. The magnitude of treatment effect was consistent with previously reported Phase 2 results, with the greatest reduction observed among the sickest patients (platelet counts = 6 units of RBC over 90 days pre entry), pacritinib therapy resulted in a clinically meaningful percentage of patients becoming transfusion independent compared to BAT. Seventy-nine percent (79%) of patients in the BAT arm of the study crossed over to pacritinib therapy.
The safety profile in the PERSIST-1 trial was consistent with prior Phase 2 trials. While the most common treatment emergent adverse events were diarrhea, nausea and vomiting, the incidence of grade 3 events was lower than observed in Phase 2 trials. No grade 4 gastrointestinal adverse events were reported. Three patients discontinued therapy and nine patients required dose reduction for diarrhea. Preliminary analysis suggests that very few patients discontinued treatment while on pacritinib or required a dose reduction due to treatment-related anemia or thrombocytopenia. Additional data from ongoing analyses along with top-line results from PERSIST-1 will be submitted for presentation at an upcoming scientific meeting.
"Despite the introduction of JAK2 inhibitors as effective therapies for patients with myelofibrosis, there remains a treatment gap for patients with disease-related or treatment emergent thrombocytopenia. The currently approved drug may require dose titration to less effective doses in this patient population, thus limiting our ability to effectively treat them. Results from the PERSIST-1 randomized trial demonstrate that pacritinib could address this unmet medical need," stated Claire Harrison, M.D., Consultant Hematologist, Guy's and St. Thomas' NHS Foundation Trust, Guy's Hospital, London, United Kingdom and one of the principal investigators for PERSIST-1. "It is encouraging to see that patients were able to receive therapeutic doses of pacritinib over a long period of time irrespective of their baseline platelet or red blood cell count while having therapeutic benefit in reduction in spleen volume and disease-related symptoms and improvement in transfusion dependency."
"PERSIST-1 is the first randomized Phase 3 trial investigating the potential benefit of a JAK2 inhibitor across a patient population with myelofibrosis that is representative of patients that healthcare providers see and treat in clinical practice," said James A. Bianco, M.D., CTI BioPharma's President and CEO. "We are excited by the clinical profile demonstrated in this randomized trial with respect to benefit-risk especially for a segment of MF patients excluded from other randomized trials with JAK2 inhibitors. We are grateful for the support and commitment of the investigators, our steering committee and, most importantly, all the patients who participated in PERSIST-1. We look forward to building on the progress we have made thus far."
"These positive top-line results illustrate the potential of this investigational treatment to become a valuable new treatment option for this challenging disease. Pacritinib is an important component of Baxter's growing oncology portfolio, and we look forward to partnering with CTI BioPharma to share these results with physicians and discussing next steps with regulatory agencies," said David Meek, Head of Oncology at Baxter BioScience.
Yes, CTI Biotherapeutics(CTIC - Get Report) is the first biotech company to break the Feuerstein-Ratain Rule, but with an asterisk.
The scenario I wrote about in January came true. CTI announced positive results from the pacritinib “PERSIST-1” study in myelofibrosis on March 9. Four months back from that date, November 9, CTI’s market value was around $350 million.
The Feuerstein-Ratain Rule says cancer drug phase III studies fail with 100% certainty when the company sponsoring the study has a market cap of $300 million or less, measured four months prior to the announcement of study results.
Taking into account inflated biotech valuations of the past two years, CTI's $350 million market cap predicted failure for the pacritinib PERSIST-1 study. But the study was a success. Therefore, the Feuerstein-Ratain Rule was broken for the first time. I predicted this would happen in January, and I was right.
Now, about that asterisk.
The Feuerstein-Ratain Rule assumes investors do a good and early job vetting the potential of a cancer drug. The market cap of the company developing the drug is a proxy for that potential. Highly effective drugs translate into large market caps long before study results are known, and vice versa.
The CTI case is different -- hence the asterisk -- because its de minimus market cap heading into the pacritinib study results was due to investor distrust (or outright disdain) for management. It had little to do with the pacritinib's chance of succeeding in in the PERSIST-1 study.
As I wrote in January, a lot of investors believe pacritinib is a real myelofibrosis drug (how good relative to competition is debatable), but they weren't willing to buy CTI stock for other reasons.
The questionable way in which CTI first refused to provide detailed data from PERSIST-1 but then dropped the data inside its 10-K a few days later was another reminder that CTI is a difficult company to trust.
CTIC premarket 1.96 , when is the 1.2 coming? Nothing in the SEC filings about cheaper shares to be offere3d today.????????????????? Jail time ?
In addition to Propanc (PPCH), in the last release we mentioned some other notable names (Stemline Therapeutics, Inc. (STML), Verastem, Inc. (VSTM), CTI BioPharma Corp. (CTIC). All of these companies have a novel approach to treatment of cancer which hopefully will result in the elimination of radiation therapy and chemotherapy in the not too distant future.
1 st green day in 8 and now you say to sell now? You don't think CTIC is worthy of a couple of green days? Fill that gap up to 2.56 on a momentum reversal. IMHO
The purchase order is for AllStar Health Brands' TapouT-branded Protein Powder, Omega-3 Fish Oil, Muscle Growth and Recovery Supplements, Instant Cold Packs and Pain Relief Spray and Towelettes.
This initial purchase order from Australia further proves AllStar's continued expansion of sales on a global scale, fueled by its high demand TapouT line. Hardcore Beverages and AllStar Health Brands anticipate strong residual sales within Australia's health and nutraceuticals market.
Dr. Daniel Bagi, President of Axxess Pharma, Inc., stated, "We are very excited to introduce to the Australian Armed Forces our globally recognized TapouT product line. As with the US military (AAFES), we anticipate continued reorders from the Australian military." Dr. Bagi further stated, "We will continue to work closely with Hardcore Beverages in expanding our TapouT sales within the country and through Asia.
Toronto, ON, March 16, 2015 /PRNewswire/ -- Axxess Pharma Inc. (AXXE) a specialty pharmaceutical and nutritional supplements company, through its wholly owned subsidiary, AllStar Health Brands Inc., is pleased to announce they have now received FDA approval from the United States to sell their high potency Omega-3 fish oil, Muscle Growth, Muscle Recovery supplements and Turbo Blend Protein Powders. The recent FDA approval comes less than two weeks after Axxess Pharma's successful meetings with two of the United States largest distributors.
Axxess's FDA approval will not only allow this new line of products to be distributed nationally into big box retail chain stores, but will also facilitate entry into more regulated markets such as Mexico and other foreign jurisdictions. Axxess expects the latest FDA approval to accelerate the pace of current overseas sales. Management is now projecting, year over year sales from March 2015 to March 2016 of $2.5 million.
Dr. Daniel Bagi, President of Axxess Pharma, Inc. stated: "We are very excited to receive FDA approval to sell our latest line of all-natural TapouT supplements and protein powders within the US. Our all-natural products will be sold under the globally recognized name TapouT, and will have the words 'FDA Approved' on every label. Our unique high potency Omega-3 fish oil supplements is anticipated to be one of our top sellers both in the US and internationally."
Do you think AXXE will pay a dividened this year as AXXE previously stated on strong sales growth?
Common Stock, par value $0.0001 per share, issuable to Beaufort pursuant to the Investment Agreement 7,142,858 (2) $ 0.20 (3) $ 1,428,571.60 $
Common Stock, par value $0.0001 per share, issued to Seaside pursuant to the Securities Purchase Agreement 200,00 (2) 0.20 (3) 40,000 4.65
Common Stock, par value $0.0001 per share, issued to Seaside pursuant to the Securities Purchase Agreement 917,300 (4) 0.15 137,595.00 15.99
Common Stock, par value $0.0001 per share, issued to Seaside pursuant to the Securities Purchase Agreement 840,520 (4) 0.1195 100,442.14 11.67
Common Stock, par value $0.0001 per share, issued to Seaside pursuant to certain side letter 100,000 (5) 0.20 (3) 20,000 2.32
Total 9,785,028 $ 1,814,261.24 $ 210.82
RAN THIS UP AND DOWN TO ACCOMPLISH ALL SELLS. lol
Short Interest EXEL
Shares Short (Current Month) 57.5M
Short Ratio 8.9
Short Interest as % of Float 29.87%
Shares Short (Prior Month) 50.9M
* Data above as of Feb 27, 2015
Exelixis, Inc., is a biotechnology company. The Company is engaged in developing small molecule therapies for the treatment of cancer. The Company is focusing on resources, development and commercialization of COMETRIQ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC) in the United States. The Company’s programs include: COMETRIQ, Cobimetinib Collaboration, and Other Collaborations. COMETRIQ, potential active anti-cancer agent and treats progressive, metastatic MTC and has therapeutic potential, as well as inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGFR2. Cobimetinib Collaboration, co-development agreement for the development and commercialization of cobimetinib which is an inhibitor of MEK, a serine threonine kinase. Other Collaborations, has established collaborations with pharmaceutical and biotechnology companies for compounds and programs.
Company Contact Info
210 E Grand Ave
SOUTH SAN FRANCISCO, CA 94080-4811
Company Ticker Closing price - March 13 Consensus price target Implied 12-month upside potential
Cytori Therapeutics Inc. US:CYTX $1.20 $5.67 372%
NeoStem Inc. US:NBS $4.03 $17.00 322%
Synta Pharmaceuticals Corp. US:SNTA $2.32 $8.75 277%
Galena Biopharma Inc. US:GALE $1.42 $5.14 262%
Stemline Therapeutics Inc. US:STML $16.01 $51.00 219%
Bind Therapeutics Inc. US:BIND $5.11 $16.00 213%
Inovio Pharmaceuticals Inc. US:INO $7.04 $22.00 213%
Peregrine Pharmaceuticals Inc. US:PPHM $1.40 $4.17 198%
Alcobra Ltd. US:ADHD $6.40 $18.67 192%
CTI BioPharma Corp. US:CTIC $1.97 $5.70 189%
IF the analists actually believe this why wouldn't they be buying hand over fist????
Bought SWC at 12.86 sold at 13.38 put in a buy at 12.91 hope it fills. Good news from auto front should help pal and swc IMHO