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Nice week here almost trading like a normal stock again
Boy does it run hot fast though RSI @ 70 already ...with volume this puppy will be a barn burner
Oh hey before I go CDEL if your reading this could you break up your ask @.38 or maybe use an iceberg order we'd get there faster .. & you can make more $ walking it up just like you've been walking it down ;)
But all the same thanks for the assist in getting the cheap shares!
http://stockcharts.com/h-sc/ui?s=ENUM&p=D&b=6&g=2&id=p76665357130
Hello?? $7 today? Anybody home?? Check the revs we @ Nasdaq numbers
Nice Close & Day!
Got back in here today Chart/Indicators really shaping up and such a crazy low M/C I hope to stay for a really long time & look to build on my position but only if I can average up :)
http://stockcharts.com/h-sc/ui?s=ANFI&p=D&b=6&g=2&id=p62586775021
It will likely consolodate here for a bit before another push but I don't see much resistance to that 2.40ish zone on the $NATGAS WEEKLY chart some minor @ 2.22 and 2.32 then 2.37 is the 50MA ... there is very strong support just above $2 after that area was resistance for weeks imo
Extremely bullish DAILY with upper bollie as the first support @ 2.05 and rising rapidly I could see it possibly staying above upper bollie for a run just like the agriculture commodities have and are doing this past week
I have no position in UGAZ - trading Futures & just added on this dip if it holds it is a higher low on the day
Mechanism Manners - a blog posted by CEO Jeffrey Bacha B.Sc., MBA
This week, we had the honor of presenting three scientific posters at the 2016 Annual Meeting of the American Association of Cancer Research (AACR). Followers of DelMar have eagerly anticipated an update on our ongoing Phase I/II clinical trial in refractory glioblastoma, for which we were pleased to have presented continued promising results..
While we share in the excitement for our GBM trial update, we are equally as enthusiastic about the other two presentations, which were quite deep in their scientific detail. These types of presentations tend to go largely unnoticed by the investing public, but they serve as exciting “food for thought” for scientists in support of the scientific foundation for VAL-083 and its future. I wanted to take a moment to explain why …
Our strategy in drug development is to take compounds with prior clinical validation and study how they work against cancer. Our hope is that by employing cutting edge biological research systems to understand the way a drug attacks the tumor, we will learn how it is unique compared to currently available treatments. If the mechanism is unique, then the opportunity to go after cancers that are underserved by today’s therapies becomes our focus.
At AACR, our collaborators from MD Anderson and the University of British Columbia presented data showing that the mechanism of our lead compound, VAL-083, is distinct from other chemotherapies.
Specifically, we said: “Treatment with VAL-083 activated DNA damage signaling pathway as demonstrated by expression of phospho-ATM (S1981), phospho-Chk2 (T68), phospho-RPA32 (S33) and ?H2A.X and VAL-083 treatment led to long-lasting cell cycle arrest at S/G2 phase of the cell cycle, leading to DNA double-strand break that continue to accumulate for at least 72 hours demonstrating irreparable damage to the tumor cell.”
Why is this important?
First, all cells – cancer and normal – employ mechanisms to detect and repair damage. In the treatment of cancer, these mechanisms can give rise to drug resistance. If two drugs act differently, then it is more likely that a cancer resistant to one treatment might succumb to the other.
Second, the opportunity to combine two treatments is enhanced when they work differently. This is important because a tumor will employ multiple repair techniques to survive treatment. If two drugs work the same way, not only will there be cross-resistance, but their toxicities are likely to overlap too and it becomes difficult to combine the drugs safely. Different mechanisms usually mean that we can often attack the tumor from multiple angles – safely.
This is what is so exciting about the data we recently presented at AACR.DMPI- cell cycle
When a cell divides, it goes through four phases:
G1: The cell gets ready to copy its DNA
S: DNA is copied
G2: The cell gets ready to divide
M: The cell divides into two cells, each with one copy of the original cell’s DNA
Typically, a normal cell employs check-point control and DNA repair mechanisms to identify and repair damage during the G1 and G2 phases. A cell can halt itself during these parts of the cycle to fix damage, or if the damage cannot be fixed the cell decides to die through a process called apoptosis. The cell uses these tools to prevent damaged cells or DNA from propagating.
Cancer cells, by their very nature tend to have mutations or deficiencies in these mechanisms that may allow mistakes to persist. Mistakes that allow uncontrolled cell division become cancer.
Different chemotherapies cause the cell to stop within its cycle and, hopefully, due to this arrest cause the cancer cell to die. Unfortunately, this often causes cell death in normal cells as well.
Interestingly, VAL-083 doesn’t appear to cause significant toxicity in normal cells. The data we presented this week provides insight into this observation. The anti-cancer activity of our lead drug candidate, VAL-083, is due to the formation of DNA cross links. When the DNA tries to divide, the strands break. These “double strand breaks” are lethal to the tumor cell. A normal cell would identify these irregularities during its check points and halt the cell cycle and fix them through a process called homologous repair.
Many cancer cells have faulty check-points, so the cross-link goes unnoticed. Through our research, we have seen evidence of the cross links persisting for days on cancerous DNA. Once the cancer cell gets to the “S” phase and begins to unwind its DNA to be copied, the cross-link ends up causing a double strand break, which is lethal to the tumor cell.
Simply put, VAL-083 appears to take advantage of the very essence of what makes a cancer cell a cancer cell!
Following treatment with VAL-083, the tumor cells become “stuck” or “arrested” in the S-phase of replication and the damaged DNA does not move forward toward mitosis. This is particularly interesting in the context of combination therapy.
There is a class of compounds that have been used to treat a number of cancers called topoisomerase inhibitors (TOPO inhibitors). These drugs, including irinotecan used in the treatment of glioblastoma, have been hampered by side effects and a narrow therapeutic window.
TOPO inhibitors require a cell to be in the S-phase for their activity. Therefore, keeping enough of a TOPO inhibitor in the system to catch cells in the S-phase leads to toxicity and side effects.
Now that we know that VAL-083 causes cells to arrest in the S-phase, combining VAL-083 with TOPO inhibitors becomes an extremely interesting proposition – to reduce side effects and enhance tumor killing!
So, what we’ve learned so far about the VAL-083 mechanism helps to explain the drug’s favorable safety profile, why it is able to treat cancers resistant to other chemotherapies and also defines opportunities for potential combination therapies in the treatment of cancer.
Oh, and another exciting thing about a unique mechanism … being different is valuable. Taxol leaped from a modest $200 million in sales to several billion once scientists understood its unique mechanism.
http://www.thechairmansblog.com/delmar-pharmaceuticals/jeffrey-bacha/mechanism-matters/
3rd ODD designation for VAL -083! Ovarian Cancer
FDA Grants Orphan Drug Designation For VAL-083 In Ovarian Cancer
New Orphan Designation is the Third Awarded to DelMar Pharmaceuticals by FDA Office of Orphan Products Development (OOPD)
08:00 ET from DelMar Pharmaceuticals, Inc.
VANCOUVER, British Columbia and MENLO PARK, Calif., April 21, 2016 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), announced today that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for its lead product candidate, VAL-083, in the treatment of ovarian cancer. The investigational drug candidate previously received an orphan designation for glioma and medulloblastoma in the United States and glioma in Europe.
VAL-083 is a "first-in-class" small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.
"We are pleased to receive the designation, which is timely in light of new data presented this week with supporting the potential for VAL-083 in the treatment of ovarian cancer," said Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals. "This announcement is representative of the progress we've made in developing VAL-083 which we believe positions the therapy as a viable treatment option for ovarian cancer patients."
DelMar's collaborators from the University of Texas MD Anderson Cancer Center (MD Anderson) presented preclinical data demonstrating that VAL-083 appears to have a distinct mode of action from platinum-based chemotherapies widely used in the treatment of ovarian cancer. In these studies, VAL-083 demonstrated an ability to circumvent cisplatin-resistance in all ovarian cell lines tested.
These new data were presented in a poster entitled, "Enhanced in vitro activity of dianhydrogalactitol (VAL-083) in combination with platinum drugs: Impact of p53 and platinum-resistance," on Monday April 18, 2016 at the annual meeting of the American Association of Cancer Research.
According to Evaluate Pharma, the market for ovarian cancer therapies is expected to be approximately $570 million in 2016 and is projected grow to more than $3.5 billion in 2022. The American Cancer Society estimates that approximately 22,000 women will receive a new diagnosis of ovarian cancer and approximately 14,000 women will die from ovarian cancer in the United States each year. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.
Ovarian cancers are commonly treated with a platinum-based chemotherapy regimen. Initial tumor response rates are relatively high; however, up to 75% of ovarian cancer patients who respond to initial treatment will relapse within approximately 18 months after completing first-line therapy. Median survival in platinum-resistant recurrent ovarian cancer patients ranged from six to nine months in published studies.
"Ovarian cancer represents the latest indication where our current research, combined with historical clinical activity demonstrated in NCI-sponsored clinical trials, supports our strategy to focus our development of VAL-083 as a new treatment option for ovarian cancer patients who have failed or are unlikely to respond to modern chemotherapeutic regimens," said Mr. Bacha. "We look forward to working with the FDA's Office of Orphan Product Development and leading investigators to advance this program alongside our ongoing efforts in glioblastoma and other solid tumors."
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company's lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients.
DelMar has been conducting a Phase I/II clinical trial with VAL-083 as a potential new treatment for glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. DelMar provided an update on this ongoing trial at AACR confirming that results to date support the potential of a VAL-083 to offer a clinically meaningful survival benefit and a promising new treatment option for GBM patients who have failed or are unlikely to respond to currently available chemotherapeutic regimens. The Company anticipates meeting with the FDA in the first half of 2016 to discuss a proposed registration-directed Phase III protocol and data from its current clinical trial with a goal of advancing VAL-083 into registration-directed clinical trials for GBM patients who have failed temozolomide and bevacizumab.
For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com / (604) 629-5989. Connect with the Company on Twitter, LinkedIn, Facebook, and Google+. Investor Relations Counsel: Amato & Partners LLC.
http://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-for-val-083-in-ovarian-cancer-300255291.html
For your astute review this paper seems to bode well for ENUM just found it this morning if you haven't already seen it
http://www.nature.com/ncomms/2016/160217/ncomms10501/full/ncomms10501.html
DelMar's VAL-083 Demonstrates Promise in the Treatment of Non-Small Cell Lung Cancer and Ovarian Cancer
MD Anderson Researchers Presented New Pre-clinical Data Today at the American Association of Cancer Research (AACR) Annual Meeting
09:00 ET from DelMar Pharmaceuticals, Inc.
VANCOUVER, British Columbia and MENLO PARK, Calif., April 18, 2016 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that the Company's collaborators from the University of Texas MD Anderson Cancer Center (MD Anderson) presented new pre-clinical data supporting the promising potential of its lead anti-cancer product candidate, VAL-083 (dianhydrogalactitol), in the treatment of non-small cell lung cancer (NSCLC) and ovarian cancer.
Abstract (#2157): "Enhanced in vitro activity of dianhydrogalactitol (VAL-083) in combination with platinum drugs: Impact of p53 and platinum-resistance," was presented at AACR during the "New Drugs, Therapeutic Targets, and Treatment Approaches" session.
In summary, MD Anderson researchers presented new in vitro data from their studies with VAL-083 indicating that:
VAL-083 induces apoptosis independent of p53 status, and appears to have a distinct mode of action from platinum-based chemotherapies widely used in the treatment of NSCLC and ovarian cancer;
VAL-083 demonstrated ability to circumvent cisplatin-resistance in all ovarian cell lines tested;
VAL-083 was active against NSCLC tumors harboring T790M, p53 and/or KRAS mutations, known to confer resistance to currently available therapies; and
VAL-083 demonstrated super-additivity or synergy in combination with platinum-based chemotherapy.
"These results support VAL-083 as a viable treatment option for refractory NSCLC and ovarian cancer patients failing platinum-based therapy as well as the potential benefit of a VAL-083-platinum combination," said Jeffrey Bacha, DelMar's chairman & CEO.
Dr. Dennis Brown, DelMar's Chief Scientific Officer, added, "The activity of VAL-083 observed in tumors harboring mutations known to be correlated with resistant phenotypes and poor treatment outcomes provides clarity and direction as we advance toward planned clinical trials in NSCLC. We can use these biomarkers for patient selection in a personalized-medicine approach to establish clinical proof-of-concept in specific tumor sub-types representing significant unmet needs within the cancer treatment market."
DelMar previously announced plans to initiate clinical trials with VAL-083 in the treatment of NSCLC in cooperation with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd., who is to provide funding for the trial in accordance with the terms of a collaboration agreement.
http://www.prnewswire.com/news-releases/delmars-val-083-demonstrates-promise-in-the-treatment-of-non-small-cell-lung-cancer-and-ovarian-cancer-300252824.html
Certainly alleviates any concerns about any cash crunch (past Q2) very timely news here
I don't expect much for the pps for a while yet but am happy to get a green light to continue building on my position a little more aggressively too ... Dr Tinkelenberg has my utmost confidence
SeeThruEquity Issues Update on DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) Highlighting Partnership with MD Anderson
Accesswire
April 14, 2016 9:00 AM
NEW YORK, NY / ACCESSWIRE / April 14, 2016 / SeeThruEquity, a leading New York City based independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced that it has issued an update note on DelMar Pharmaceuticals, Inc. (DMPI), a biotechnology company focused on proven cancer therapies in new orphan drug indications where patients are failing modern targeted or biologic treatments.
The note is available here: DMPI April 2016 Update. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack's. The report will be available on these platforms. The firm also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
"Since our last update on the company, Delmar has announced a major new collaborative partnership with the University of Texas MD Anderson Cancer Center. In our view, the announcement underscores the progress Delmar has made in showing that VAL-083 has potential to significantly improve the standard of care for GBM, and the management has stated that it believes the small molecule may offer measurable "advantages over currently available chemotherapies in a number of tumor types." In the announcement, Delmar indicated that MD Anderson had agreed to "extend and accelerate" the clinical development of VAL-083 for glioblastoma multiforme patients following first recurrence of the disease. As part of the collaboration, MD Anderson has agreed to initiate a new Phase II clinical study with VAL-083 at first recurrence/progression, prior to Avastin® exposure. Eligible patients will have recurrent GBM characterized by a high expression of MGMT, the DNA repair enzyme implicated in drug-resistance and poor patient outcomes following current front-line chemotherapy," commented Ajay Tandon, CEO of SeeThruEquity. "We are reiterating our price target of $5.75 per share."
Additional highlights from the update note are as follows:
Encouraging partnership with MD Anderson
Delmar began the year well, with an encouraging collaborative partnership announcement with the University of Texas MD Anderson Cancer Center (MD Anderson). The agreement calls for MD Anderson to initiate new clinical studies of Delmar's lead candidate, VAL-083, for treatment of recurrent glioblastoma multiforme (GBM), the most common and deadly form of brain cancer in a randomized, open label Phase II trial.
FDA Grants second orphan designation for VAL-083On March 15, 2016
Delmar announced that the FDA granted its lead product candidate, VAL-083, orphan drug status for a second indication – for the treatment of medulloblastoma. Medulloblastoma is the most common malignant pediatric brain tumor, accounting for It accounts for 15-30% of all childhood intracranial neoplasms, with a poor prognosis for certain subtypes of medulloblastoma and recurrent disease at a median overall survival of less than one year. We see this announcement as a significant one by Delmar and representing nice execution by management. The achievement of orphan designation accelerates the potential timeline for clinical advancement to help treatment a patient population with few options.
Delmar to present key data next week at AACR
Delmar management will be presenting three abstracts at this year's upcoming American Association of Cancer Research (AACR) annual meeting on April 18-19, 2016. The abstracts will be based on research conducted with VAL-083 (dianhydrogalactitol), a "first-in-class" small-molecule chemotherapeutic agent which is the company's lead anti-cancer product candidate This is clearly a significant industry event, and a significant showcase opportunity for the company. Importantly, these will include a new update on the company's Phase I/II clinical trial of VAL-083 for Refractory GBM, which will be released on April 19, 2016.
https://finance.yahoo.com/news/seethruequity-issues-delmar-pharmaceuticals-inc-130000767.html
Enumeral and Pieris Pharmaceuticals Enter into License and Transfer Agreement
April 18, 2016 06:45 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Enumeral Biomedical Holdings, Inc. (OTCQB:ENUM) (“Enumeral” or the “Company”), a biotechnology company focused on discovering and developing novel antibody-based immunotherapies to help the immune system fight cancer and other diseases, today announced that it has entered into a License and Transfer Agreement (the “License Agreement”) with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH (collectively, “Pieris”).
Pursuant to the terms and conditions of the License Agreement, Pieris is licensing from Enumeral specified intellectual property related to Enumeral’s anti-PD-1 antibody program ENUM 388D4 for the potential development and commercialization by Pieris of novel multispecific therapeutic proteins comprising fusion proteins based on Pieris’ Anticalins® class of therapeutic proteins and Enumeral antibodies in the field of oncology.
Under the License Agreement, Pieris has agreed to pay Enumeral a $250,000 initial license fee, and Enumeral is providing Pieris with sequence and related information for Enumeral’s 388D4 family of anti-PD-1 antibodies. The License Agreement provides that Pieris may continue the license by paying Enumeral an additional maintenance fee in the amount of $750,000 by May 31, 2016. In the event that Pieris does not pay this maintenance fee by May 31, 2016, the License Agreement expires and the license granted thereunder automatically terminates.
If Pieris elects to continue the license and pays Enumeral the maintenance fee, the License Agreement provides that Pieris shall also receive a twelve-month option to license Enumeral intellectual property related to an additional antibody program on subject to the Subsequent Option will be selected by Pieris from a specified list of antibodies owned by Enumeral. In the event that Pieris exercises the Subsequent Option, Pieris will pay Enumeral an additional undisclosed license fee.
The terms of the License Agreement provide for Pieris to pay Enumeral development milestones of up to an aggregate of $37.8 million upon the achievement of specified events, as well as net sales milestone payments of up to an aggregate of $67.5 million upon the achievement of specified net sales thresholds. Under the License Agreement, Pieris also agrees to pay Enumeral royalties in the low-to-lower middle single digits as a percentage of net sales depending on the amount of net sales in the applicable years. In the event that Pieris licenses an additional antibody pursuant to the Subsequent Option, any resulting fusion protein products will be subject to additional royalties and development and sales milestones in the same amounts applicable to the fusion proteins linking PD-1 and Anticalins under the initial license.
“We are excited that Pieris has decided to work with our antibody sequences, and we are encouraged that these sequences could become part of a novel class of therapeutic based on Pieris’ Anticalin platform,” said Cokey Nguyen, Ph.D., Enumeral’s Vice President of Research and Development. “Enumeral has been able to generate antibodies using our proprietary platform technology in a very efficient manner, and this transaction is further validation of the Enumeral approach. We look forward to working with Pieris as we pursue our mutual interests under the License Agreement.”
“Gaining access to Enumeral's valuable PD-1 antibody IP not only enables Pieris to leverage its antibody-Anticalin multispecifics capabilities with a cornerstone immune checkpoint inhibitor, but also brings a high level of intra-pipeline synergy, including with Pieris’ lead CD137 bispecific immune costimulator candidate PRS-343,” commented Pieris President and CEO, Stephen S. Yoder. “This license gives Pieris an opportunity to independently develop anti-PD-1 antibody-Anticalin multispecific immune checkpoint inhibitors as next generation cancer immunotherapeutics.”
About Enumeral
Enumeral is a biopharmaceutical company discovering and developing novel antibody immunotherapies that help the immune system fight cancer and other diseases. The Company is building a pipeline focused on next-generation checkpoint modulators, with initial targets including PD-1, TIM-3, LAG-3, OX40, and VISTA. In developing these agents, Enumeral’s researchers apply a proprietary immune profiling technology platform that measures functioning of the human immune system at the level of individual cells, providing key insights for candidate selection and validation. For more information on Enumeral, please visit www.enumeral.com.
About Pieris
Pieris Pharmaceuticals is a clinical-stage biotechnology company that discovers and develops Anticalin-based drugs to target validated disease pathways in a unique and transformative way. Pieris’ pipeline includes immuno-oncology multi-specifics tailored for the tumor micro-environment, an inhaled Anticalin to treat uncontrolled asthma and a half-life-optimized Anticalin to treat anemia. Proprietary to Pieris, Anticalins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin®, Anticalins® are registered trademarks of Pieris. For more information, visit www.pieris.com.
http://www.businesswire.com/news/home/20160418005451/en/Enumeral-Pieris-Pharmaceuticals-Enter-License-Transfer-Agreement
Might be the beginning of the end of manipulation
https://www.marketslant.com/articles/april-19th-catalyst
It is puzzling to say the least and would be nice to hear an explanation ...canceling Kodiak made sense after that c/c ...but only to bring in Lincoln Park and say nothing?
Strange and dare I say disingenuous
Thank you kindly RK for your synopsis looking forward to the evolution in whatever form it takes.
The verbiage does seem to imply a possible buy out or going back private ... what will happen to shareholders in the latter circumstance?
Finally got 2 more of my GTC's filled .15 & .16 last week while on a short vacation
Anybody taking advantage & buying in this range will instantly double when we finally get to the chase imo ...Not to say I am selling there, I just hate chasing ;)
Loving the VOLUME & price action!
I have seen a concerted effort to raise awareness here is one I came across today -
Rodman & Renshaw initiated coverage and issued a BUY rating with a $3 pps objective.
http://sleekmoney.com/delmar-pharmaceuticals-inc-dmpi-now-covered-by-analysts-at-rodman-renshaw/1087234/
There have been numerous but here is another article from last week and supports your thoughts on the ODD designations taking notice
http://wealthyventurecapitalist.com/2016/03/30/booming-orphan-drug-market-provides-investors-with-massive-return-prospects/
Yes it is a low float and that is easy to read on the chart ... I think the spike late '15 was a sign of things to come and that with so much more happening in '16 this climb will sustain and go higher ... possibly even before the late breaking on 4/19
Good Morning Bill, you posted today's headline but the rest is the PR from March 24th so I thought I'd give it a shot ;)
Soligenix Announces Publication of Preclinical Efficacy Results with Dusquetide in Infectious Disease
Preclinical Results Supported by Recent Positive Phase 2 Clinical Trial
07:00 ET from Soligenix, Inc.
PRINCETON, N.J., March 29, 2016 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the publication of data demonstrating the mechanism and broad-spectrum activity of dusquetide in preclinical bacterial infection models. Dusquetide, also known by the research name SGX94, is a novel Innate Defense Regulator (IDR) composed of 5 amino acids and is the active ingredient in the lead IDR drug product, SGX942. Recently, SGX942 demonstrated positive results in a Phase 2 clinical trial of oral mucositis in head and neck cancer patients receiving chemoradiation therapy, not only reducing the duration of severe oral mucositis, but also reducing the incidence of infection as well as potentially enhancing the anti-tumor response. The preclinical results were published online in the Journal of Biotechnology and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.
As an IDR, dusquetide modulates the innate immune system by interacting at an intracellular integration point, operating downstream of most innate immune receptors and upstream of most cytokine and chemokine effectors. IDRs directly interact with an important protein known as p62, or sequestosome-1, thereby enhancing anti-infective mechanisms of the innate immune system and decreasing the often deleterious inflammatory responses. Because IDRs such as dusquetide target the host innate immune system, and not the bacteria directly, they are effective irrespective of the specific biological characteristics of the bacteria, whether antibiotic sensitive or resistant, gram-positive or gram-negative, intracellular or extracellular. IDRs are also complementary to antibiotics, and may provide an important tool in the fight against antibiotic-resistant and emerging infectious diseases.
Innate immunity is not only triggered by infection, but also by tissue damage. As such, IDRs also provide an ability to modulate inflammatory reactions to tissue damage, such as in the pathogenesis of oral mucositis. In a Phase 2 clinical trial, SGX942, containing dusquetide at a dose of 1.5 mg/kg, successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy for treatment of their head and neck cancer. In addition to the oral mucositis findings, an increased incidence of "complete response" of tumor at the one month follow-up visit was observed (47% in placebo versus 63% in SGX942 at 1.5 mg/kg). Decreases in infection rate were also observed with SGX942 treatment.
"The IDR technology was initially discovered in the context of infectious disease. Because IDRs target the host innate immune system, and not the bacteria, they are effective even when the bacteria are antibiotic resistant. Extensive testing has been done in the context of methicillin-resistant Staphylococcus aureus (MRSA) and has demonstrated that IDRs not only are effective as stand-alone therapy, but also are complementary to antibiotics, allowing a "two-pronged" attack on the bacterial infection," stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "The Phase 2 results not only confirm the potential efficacy of IDRs in the context of oral mucositis, but also prove that the unique biology of IDRs translates well into the human clinical setting. The multiple modes of efficacy observed in the Phase 2 study and the demonstrated safety in both the Phase 1 and Phase 2 clinical trials were very consistent with the preclinical findings and the highly conserved nature of the innate immune system."
"These data demonstrate the broad and promising potential of our IDR technology platform," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "While we continue to actively develop dusquetide for the treatment of oral mucositis, we are also poised to expand the platform to the infectious disease space and hope to fund these advancements through both partnerships and government grants/contracts, such as we have done to date with Burkholderia pseudomallei infection, a category B biothreat agent and the causative agent in melioidosis, an endemic tropical disease which is poorly treated by antibiotics."
These studies were partially funded with grants from the National Research Council of Canada Industrial Research Assistance Program, agreement #703724, the National Institutes of Allergy and Infectious Diseases Small Business Innovation Research grant # 1R43 AI108175-01A1 and grant # 1R43DE024032-01.
About SGX942
SGX942 is an innate defense regulator (IDR), which contains a new class of short, synthetic peptide, having the chemical name dusquetide. It has a novel mechanism of action in that it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis and other bacterial infections.
SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Recently, SGX942 has demonstrated preliminary efficacy and safety in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation (CRT) therapy for head and neck cancer. Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients exposed to the most aggressive concomitant chemotherapy, the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04). The p-values meet the prospectively defined statistical threshold of p<0.1 in the study protocol.Additional observations included an improved tumor response to CRT therapy at the one month follow up visit (47% in placebo versus 63% in SGX942 at 1.5 mg/kg), as well as decreases in infection rate.
Dusquetide and related analogs have a strong intellectual property position, including composition of matter. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada.
SGX942 has received fast track designation from the US Food and Drug Administration (FDA) for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients. Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX942 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis and infectious disease.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
http://www.prnewswire.com/news-releases/soligenix-announces-publication-of-preclinical-efficacy-results-with-dusquetide-in-infectious-disease-300242175.html
Nice to hear from a fellow long term investor thanks for your insight I hope you continue bring it here. I am in the middle of a big contract for my real job haven't been checking in here the past few days
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I am relatively new to DMPI caught my attention early fall '15 and went straight to my watch list but I failed to act on it (was busy with my real job during the start of the Oct ascent) and I watched it get away on me lol when the pps was visiting the $1.50 area in Nov .. I was pretty mad at myself so needless to say the pull to these levels was an opportunity I was not letting slip twice....have bought in 3 tranches so far .85, .95 & 1.05 the highest cost being my starter in December.(I was fooled on the gap up day but didn't want to let it get away again lol)
Am absolutely willing to average up or down whichever way the wind blows .. pps seems to be shoring up in this range my long standing GTC @ .75 has never filled
We should see those warrants execute Q2 or 3 imo with the awareness here rapidly growing and the late breaking will bring more long term investors in short order. Share structure & low float is ideal for an organic up list one day and being QX adds to that credibility
I too was initially attracted to Delmar for the likelihood of a very rapid commercialization process having picked up successful but abandoned protocol and sales already underway in China, which lends further credence to the possibility of your speculation. Thanks for sharing, should be an exciting year!
Another aspect that is appealing, though I won't hazard a guess as to the chances, would be for the FDA to approve val-083 for refractory GBM superceding the requirement for a phase 3 trial. Definitely a possibility due to the historical clinical background of the drug, the lack of options for these patients, and the efficacy shown through the phase 1/2 trial to date. I think there is a chance for this to happen saving Del Mar some serious money.
Nice find! Very impressive how we are already diversifying and maximizing revenue opportunities in such a wide ranging variety of verticals
I tend to think so it did spook ... if it was BMAK selling a few company shares maybe to pay for this filing/accountant and upcoming 10K he got the deed done quickly and booked out for the day but I do wonder how things would have went breaking up the sells and even up ticking with us.
Oh well one good thing is the flippers are the ones who got spooked off and the less the better we can sustain pps growth better with less of them.
I can't put my finger on any bad news at all in the 8K/A and it confirms the pps is undervalued but the initial selling triggered a bad sentiment it seemed ... it was Friday Buy Day on all OTC's I am in ..Big boards did too good today for any real volume down here.
we will slowly uptick to around .015-.017 next week, and possibly touch .03 by EOM
My take on the price action
Haven't seen anyone mention but BMAK was here out of the gate and whacked off on the bid a fair amount then quickly disappeared completely and now no where to be seen... with the price going wrong way, red money flow, & BMAK frightening potential ask slappers who quickly move on for now, it was followed by most of the flippers who got sub penny running for the exit and/or stops getting hit.
Of course all that set the tone to this point ... IMO it is temporary when ask slapping commences we roll green in the PM... I was surprised when BMAK vanished it didn't take hold already but now it's who will flinch first
I think we are down to longs again with everyone standing pat.
Revs vs. M/C = steep correction still on the way ...just maybe not on a Friday but I do expect to finish green today and a delayed 'rational' reaction in to next week & beyond.
Yes let the limelight shine ;) ..btw thanks so much for posting those and on the other board too definitely looks exciting for Q2
Nice move here today volume increasing daily as awareness spreads with the float still less than 40M should see a $ in front of pps shortly
New article/coverage .. i think ...forgive me if it isn't there have been many of late getting hard to keep track
http://investingnews.com/company-profiles/delmar-pharmaceuticals-cancer-gbm-treatment/
States we are funded through Q3 in this one
New blog from CEO Jeffrey Bacha affirms this is an incredible opportunity to go long ....really long ;)
Sweet news yesterday now 2 indications with ODD and the likelihood of more coming considering the scope of our focus
http://www.thechairmansblog.com/delmar-pharmaceuticals/jeffrey-bacha/unlocking-the-value-of-independent-commercialization-2/
Got some better volume yesterday ... today everywhere anemic awaiting feds tone but L2 looking up here
Thank you Mr.James that's a nice concise summary of our developments and a reminder the run here has barely begun ...the majority of traders/investors will arrive like a herd of sheep when what we already know is confirmed publicly
Hey PITYboy is that a lime peel that covers your ears?.. now it's stinging your eyes??
Not even close to OVERANYTHING
Beautiful consolidation and cooling period last week and reset, RSI now on the RISE and won't get as hot as fast, Friday touched the 10 dma @ .0131 ...support defined = YOUR GOING THE WRONG WAY!!! I expect it will be easy pickins to get back above .0154 then 2's.
http://stockcharts.com/h-sc/ui?s=HPTG&p=D&b=9&g=4&id=p22535353050
Watch what happens when the 11 dma I have overlaid on the rising RSI intersect = next leg up
Really appreciate the DD it seems ProStar has the capacity, wherewithal & ambition/initiative to grow exponentially for years to come as they certainly have had a very impressive first 3 years just scratching the surface of what we can already ascertain.
I still can't believe our good fortune to merge at this stage when profitability and further growth are reaching a climax and initial front end 'start up' costs in the rear view mirror
In other words at a point where 'start up' has already matured to 'growth phase' and now leading in to 'growing to the next level'
Obviously a well executed business plan to get to this stage
PPS re-value in progress much more to go .. M/C still a measly $4.5M will be interesting to see where it is in at the end of the year
That's fantastic! Great work you are always ahead of the class. I had found a link suggesting this but it was a dead link that wouldn't work and so I wasn't sure if AACR had already happened lol or if plans were averted, or info leaked that shouldn't have etc...
Further investigation of that dead link just now brought me to this mysterious page ...still no info but something to keep an eye on
http://vaccinelogix.com/
Edit: That link you provided is not working for me ...maybe Canadians just aren't allowed to know lol
Thanks for that! Indeed very encouraging and exciting times, that young man was certainly speaking in terms that align perfectly with speculation over at TeePeeIV ... I sure hope so I'm still very heavily weighted in that one been waiting quite a while for the re-value upward coming over there too ...seeing this interview first hand from the horse's mouth, Jason Coloma / Roche, as opposed to just message board poster hearsay, helps to substantiate the likelihood of that outcome coming to fruition
Has this interview ever been posted over there?
Being honest I was contemplating trimming some over there the chart is looking a little ominous & hanging by a thread ... seeing this video helps to keep me from jumping off that ledge lol
But if I sell some it is a surefire way to make it double the next day lol
Charts are secondary to me to fundamentals ...certainly ENUM is no chart play and recent history lacks volume, but having said that it is noteworthy that accumulation and the MacD both strengthening here at ENUM as well as other indications ChiOsc, Trix, CMF steadily rising, NVI is positive & others... suggests bulls are stepping in here as does the line being held @ .16 ...if it does not go lower than that, which the sellers don't seem too keen on so far, I expect peeps will realize this train will leave the station with out them as the ascent from bottom gains strength. Any watchers waiting on confirmation of bottom could take this to .40's in a New York minute ;)
http://stockcharts.com/h-sc/ui?s=ENUM&p=D&b=9&g=4&id=p77158802778&a=428085219
Also came across this one on one interview w/CEO Arthur Tinkelenberg that took place @ Biotech Showcase had not seen this one before
I haven't seen anything either maybe they don't need anymore investor presentations if they perhaps already have some major funding in the works?? possibly as a result of several presentations back to back they partook in Dec/Jan ...after they announced the newest collab with MD Anderson Jan 11, I bet that opened a lot more eyes in the bio tech world ...that is a pretty big deal ... not to mention the collab/backing ongoing for over a year with Merck and they have been rubbing shoulders with several big players in the recent past ie: Novartis, Janssen
Has indeed been very quiet on that front hmmmm
One of the biggest attractions for me to this stock is the extreme likelihood of anti dilutive capital through partnerships that will likely come quickly and that will re-value this ticker overnight ...on the novel approach & IP $ENUM stands alone
I know you already know this feel like I am preaching to the choir lol I am just reiterating our thoughts for the benefit of any new investors browsing this board ... there were so many party pooper posts in a row a lot of good stuff got buried hehe
I did stumble across this article @ Seeking Alpha from June 29/15 submitted by David Bautz ...forgive me if this has been posted before ...very good in depth analysis and has assessed a market cap of $100M for where we are now! ..and that was back in June!
http://seekingalpha.com/article/3291465-enumeral-biomedical-is-an-overlooked-player-in-immuno-oncology
Our price target of $2.00 per share corresponds to a market cap of approximately $100 million, which we think is appropriate at this point of time if the company executes on its objectives and is able to see its lead programs progress into Phase I clinical testing by the end of 2016.
8K tonight - Polished Slide Presentation updated 03/16
http://archive.fast-edgar.com//20160311/APK6F22CJ222V9ZF222G2ZZF4UW7Z222Z282/
In my experience R/S is only bad when it is a pre-revenue company and/or their main business is selling shares
It is usually a happier ending when a company is generating revs. This company seems to already be in a higher tiered league with substantial revs and rapid growth doing the R/S for the right and deserved reasons - intent to up list & higher class/institutional investor rather than the flippers found here in the sewers. Well on their way to qualifying for Naz with the recent contracts and likely more coming we don't know about yet.
R/S won't in itself change the market cap (only $3M?? wow what a diamond in the rough) which is crazy low for what is coming on the books
I think today was likely the worst of the capitulation we will see
I wouldn't be surprised if they put out more news between now and the trailing D and we are higher when it happens with a $ in front of pps now that most that wanted to bail did so and everyone else knows it's coming
I'm certainly sticking around but somewhat disappointed it didn't go lower and fill my .032 bid today ..so close
Hi Ron ya the overhang sellers from the last operation still out number buyers as awareness about Enumeral and this reverse merger is still limited...Hence the pps has drifted south for over a year from the insiders of the shell pre-ENUM selling in tranches every month...
Further to that even those discovering ENUM are likely waiting on the sidelines to see where the bottom will be.
I have not 'bailed' I just keep accumulating/avg down and have GTC bids at several increments down to .10 in case it goes there when I am not looking... though they never seem to show lately on L2 so I HOPE they are there lol ...but knowing mine don't always show here (even at times where it was top bid) I imagine there are other bids not showing too ... on these quiet tickers the MM's seem to get kinda lazy ...I can assure you from just me there are 3 more bids in between the .124 & .165 currently showing and my normal MM I route through isn't even there at the moment ...puzzling ...I'll take it as a clue that perhaps .16 is the bottom so my MM not getting out of bed for my low ball bids lol
ARCA & NITE seem to be the biggest sellers here while it is my belief we see CDEL & CSTI working in tandem to exploit this waiting period and average down what are likely relatively large positions already. Pure speculation but CDEL & CSTI always seem to be the ones to jockey for highest bid
Not sure which will happen first:
A) The sellers will run out of shares and the pps will jump to the 30's and beyond in a flash
B)Enumeral puts out some substantial news and the pps will jump to the 30's and beyond in a flash
Wow just had a GTC fill did not ever expect that but there was that gap is why I put it in lol GREEN ALREADY YAAAY!!
Nice about the warrants when I saw that couple days back I nearly cancelled the GTC thinking the reaction here would be opposite but today looks like those who have stops are getting knocked out ...quite the flush again
And that stays true for one more 10-K due end of this month as we now transition to a fiscal year end of 12/31 going forward
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11098623
It's a bonus we will get to see several months of ProStar operations since the acquisition, looking forward to it
There is no 10-Q expected when we are at year end ... the next filing is a 10-K ..in other words every year there are 3 10-Q's and 1 10-K
Your prior post depicted the correct timelines for filing but where you are confused is you seem to be waiting for a 10-Q that is not coming ..we await the 10-K due 03/31
Edit: I believe HPTG just changed their year end to the calendar year ..prior their year end was 03/31 perhaps that is why you are expecting the Q but I believe that change was on an 8K within the past few months
C'mon ARCA, NITE & 'RONGPOOPEIL' ... go ahead and make it RAIN!!
Have PLENTY with the TWENTY, (handle) but am KEEN to catch more TEEN(s)
I'm next on the bid now don't leave me hangn'