Now note this as per GALE - SEC filling for Q2 results.
Received Notice of Allowance of Broad U.S. Patent for NeuVax™ (nelipepimut-S). Allowed claims cover the use of NeuVax alone or in combination to prevent recurrence of any HER2/neu expressing tumor having a fluorescence in situ hybridization (FISH) rating of less than about 2.0. FISH is a diagnostic test used to identify patients with high levels of HER2 gene expression, or FISH greater than 2.0. These patients are eligible for existing approved HER2-directed treatments. Currently there are no approved HER2-directed therapies for patients who express lower levels of HER2, or less than 2.0 by the FISH testing scale. The patent will cover the use of NeuVax in patients with a FISH of less then about 2.0, as a stand-alone therapy or in combination with an adjuvant and/or other agents (e.g. other drugs such as Herceptin® (trastuzumab; Genentech/Roche)). Importantly, this NeuVax patent provides Galena with coverage for any tumor expressing low-to-intermediate levels of HER2. Once issued, the patent will expire in 2028, not including any patent term extensions.
Can't hold then give up cause once it breaks 2.4 it might go back 3 ...4...5 Trust me Adam is exhausted with his fanatic on GALE by now.
Galena Biopharma Reports Second Quarter 2014 Results
August 11, 2014
Loosing worried !!!!! How much you can loose if this break - Cover soon PBYI is $250
The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the U.S. Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study.
. "We are excited for the second half of the year as we continue to advance all of our programs. Our two, key expected milestones in clinical development are completion of enrollment activities in our international, Phase 3 NeuVax PRESENT study, and the initiation of the Phase 2 clinical trial with GALE-401. Commercially, we continue to gain traction with Abstral, and we have begun preparations for the launch of Zuplenz in early 2015."
According to PBYI, this represents the first trial with a HER2 targeted agent that has shown a statistically significant benefit in the extended adjuvant setting, which the company believes provides a meaningful point of differentiation for neratinib in the treatment of HER2 positive breast cancer Phase III clinical trial of the company's investigational drug PB272 (neratinib) for the extended adjuvant treatment of breast cancer (ExteNET Trial).
Adam Feurestein writes.......
blockbuster cancer drug Herceptin works similarly, except it's not a vaccine but an antibody that attaches to HER2 receptors on breast cancer cells. In order for Herceptin to be effective, however, the breast cancer cells must overexpress HER2, meaning the cells need to have large numbers of HER2 receptors on their surface.
If NeuVax trains T cells to recognize and destroy HER2-expressing breast cancer cells, the vaccine should work best in tumors where HER2 expression is highest. This makes sense, right? After all, it should be easier for those newly trained T cells to find tumor cells if the target (HER2) is illuminated with the molecular equivalent of red paint and strobe lights.
Based on other encouraging studies using NeuVax and Herceptin in other treatment settings, this study explores this promising combination approach of complimentary targeted agents in clinically high-risk HER2 3+, or positive, patients," added Dr. Mittendorf
It means big pharma believes that NeuVax works and worth spending $12Millions upfront. Second possibility worth takeover.
Nobody tracks the "real numbers" but it estimated that one million people in the United States, per year, receive chemotherapy.
Chemotherapy is not just one thing..it simply refers to the chemical treatment (medication) of cancer. There are dozens of different drugs used on a wide variety of schedules, depending on the type of cancer being treated.
How Many People Get Chemo A Year?
I'm a chemo patient.
Estimated New Cases in 2014 ALONE is 1,665,540
Zuplenz contains ondansetron, which inhibits the neurotransmitter serotonin, thereby reducing nausea and vomiting. Galena says the oral thin strip version of the drug, administered via the top of the tongue, works better than the tablet formulation because it eliminates the burden of swallowing pills during episodes of vomiting, resulting in improved patient compliance
Galena investors of all stripes might have chosen to sell out and collect some profits after the stock's rise. That its executives did the same might be totally on the up-and-up. But in any case, the SEC is investigating Galena and its DreamTeam relationship, the company has said. As questions arose, the board launched its own investigation--and the company appointed a former SEC enforcement attorney to join those directors.
Not the sort of thing a company wants to announce in a press release (though it did disclose the probes to investors in an SEC filing). Now, Ahn's replacement, Mark Schwartz, has to manage the aftermath, step up marketing and sales for that newly licensed drug, Zuplenz, and keep that immunotherapy moving. Did we mention the lawsuits filed by shareholders--or Galena's own libel suit against the co-developer of its cancer vaccine? Meanwhile, Ahn himself says (as quoted by TheStreet) that he's "looking forward to the new adventure."
Dr. Schwartz served for five years as President and CEO of Bayhill Therapeutics, a company developing an innovative DNA vaccine platform for the treatment of autoimmune diseases where he completed a successful partnership with Genentech for the development of the company's Type 1 diabetes vaccine.
NO DUMPING BUT ITS SHORTING ...LOL
Some wasted interest after GALE but remember PHASE-3 anything can happen...