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The Supplemental Information at the end of the Pre Print is pretty cool too
UP/OM/ABSSI/E.Coli and info presented as well
Let the PR Parsing begin..
Innovation Pharmaceuticals Granted European Patent for Brilacidin in the Prevention of Oral Mucositis
GlobeNewswire•December 12, 2017
BEVERLY, Mass., Dec. 12, 2017 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (IPIX) (“the Company”), a clinical stage biopharmaceutical company, announced today that the European Patent Office has granted a European patent for Brilacidin, the Company’s first-in-class defensin-mimetic, in the prevention and control of Oral Mucositis (OM). Brilacidin-OM is being developed under an FDA Fast Track designation for this indication.
The European patent supplements other Brilacidin-OM patents that have been granted in the United States, Asia (Japan, Taiwan, China), Oceania (Australia) and South Africa. All currently issued patents have an expiration date of 2032. Additional Brilacidin-OM patent applications are pending in other key markets including Russia and South Korea.
The European patent is part and parcel to the Company’s strategy to develop and commercialize Brilacidin-OM internationally through licensing agreements. An estimated 700,000 (source:GLOBOCAN) Head and Neck Cancer (HNC) patients worldwide will develop OM this year, with the figures expected to climb to over one million annually by 2023. In spite of OM incidence rates ranging as high as 100 percent in HNC, there currently are no FDA-approved drugs for the prevention and treatment of OM in these types of cancer patients receiving chemoradiation.
“We are looking at a global product opportunity with OM that is extremely attractive and intellectual property protection is critical. With no approved drugs for our initial target indication in preventing OM in HNC, the first company to commercialize a safe and effective drug would undoubtedly command a significant portion of the market, which is estimated to be at least $1 billion worldwide,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.
“The topline data released yesterday from our Phase 2 trial showed a meaningful reduction in the incidence of severe OM even compared to a rate somewhat lower than historic norms in the placebo arm, demonstrating Brilacidin-OM’s clear effect in preventing this extremely painful, and at times even deadly, consequence of chemoradiation in a majority of HNC patients treated with the drug. I can’t imagine a physician not wanting to prescribe, and a patient not wanting to use, a simple oral rinse like Brilacidin-OM if it would mean cutting the chance of developing severe OM by as much as 38.7 percent, as observed in patients who adhered to the requirements of the trial protocol,” Mr. Ehrlich continued.
“Given the positive topline data, the Company is compelled to aggressively seek a development path that will most efficiently bring Brilacidin-OM to patients in need,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We intend to work diligently with the FDA and other health authorities, on a worldwide basis, and ideally in collaboration with interested potential partners, to achieve this goal. We have a potential 'game changer' asset with Brilacidin-OM, able to make a big impact on a cancer patient’s well-being, and we are in the privileged position of planning wholeheartedly for the next stage of development as we strive to be the first to fill a wide void in oncology as quickly as possible.”
About Brilacidin
Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.
What's with the 100 share trades every 30 seconds
Aruda must be buying...
Promising Strategy to Increase Activity in Antimicrobial Peptides
trying to post a link to this but having issues...
In an article published recently in Plos One, researchers from INRS-Institut Armand-Frappier Research Centre reported a strategy that could lead to the discovery of new cationic antimicrobial peptides (CAMPs) with greatly enhanced antimicrobial properties. The peptide modified for the study retained considerable activity against biofilms responsible for increasing the severity of various infections. The strategy thus holds promise for combatting multidrug resistant bacteria.
For the purpose of the study, the researchers selected a peptide--pep1037--already known for its antimicrobial potential and antibiofilm activity against Pseudomonas aeruginosa and Burkholderia, two pathogens responsible for serious complications in individuals with cystic fibrosis. The peptide was modified by adding a cysteine to the end to generate a dimer. The antimicrobial activity of the new molecule was 60 times greater than that of the original peptide.
"Our results show that the dimer is of significant interest because it has a dual potential to inhibit both bacterial and biofilm growth. It could potentially be used for therapy in combination with clinically relevant antibiotics," explained the authors of the study.
Although there are currently no clinically approved antimicrobials that target bacterial biofilms, an estimated 80% of all bacterial infections have a biofilm component. These infections are much more difficult to eradicate because they are 10-1,000 times more resistant to antibiotic treatment. The formation of biofilms is associated with severe antibiotic resistance in the lungs of patients with cystic fibrosis, among others.
To date, very few studies have reported on the effect of dimerizing cationic antimicrobial peptides by adding a cysteine, especially at the specific location modified by the researchers, i.e., at the end.
The results obtained pave the way to improving this class of antibiotics, which occur naturally in many organisms.
http://www.rdmag.com/news/2017/04/promising-strategy-increase-activity-antimicrobial-peptides?et_cid=5900737&et_rid=358586622&location=top&et_cid=5900737&et_rid=358586622&linkid=content
As many times as you post about a R/S?
Nice little volume spike.
Rosen has the ball...
hope they Cam Newton it....
Cellceutix Meets With FDA for Phase 2 Clinical Trial of Kevetrin for Ovarian Cancer
https://finance.yahoo.com/news/cellceutix-meets-fda-phase-2-192244126.html
BEVERLY, MA--(Marketwired - February 10, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that Cellceutix executives met this week with staff of the FDA Division of Oncology Products 1 to discuss the Kevetrin Phase 1 study data, as well as a proposed design of a planned Phase 2 trial in patients with ovarian cancer that have resistance to platinum-based therapy.
The FDA has agreed with Cellceutix's plan to initiate such a trial, and based upon the data from the Phase 1 trial, that the administration of Kevetrin doses at three times per week would be acceptable. The FDA provided excellent guidance regarding several aspects of the planned protocol, including the proposed trial endpoints and insights regarding drugs to be used in combination with Kevetrin. Cellceutix will release additional information on these details when appropriate.
The phase 1 trial of Kevetrin trial yielded exciting data validating the safety of Kevetrin and suggestive evidence of the potential clinical benefit of Cellceutix's novel p53-targeting compound in patients who had relapsed after other cancer treatments. Because of the relatively short half-life of Kevetrin in plasma, it is the Company's belief that administering Kevetrin multiple times per week may have a clinical benefit in the planned Phase 2 trial in patients with ovarian cancer. The meeting with the FDA was very productive, as their guidance was forward- thinking and quite helpful as Kevetrin advances on its clinical pathway.
Cellceutix is developing Kevetrin under an Orphan Drug designation for ovarian cancer from the U.S. Food and Drug Administration (FDA).
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Cellceutix clinical trials on Clinicaltrials.gov:
Cellceutix to Submit Special Protocol Assessment Request to FDA for Phase 3 Clinical Study of Antibiotic Brilacidin for ABSSSI
https://finance.yahoo.com/news/cellceutix-submit-special-protocol-assessment-142500208.html
BEVERLY, MA--(Marketwired - February 09, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that it will be submitting a Special Protocol Assessment (SPA) request for phase 3 clinical research of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria. The Company anticipates submission of the SPA request to the U.S. Food and Drug Administration (FDA) within two weeks.
In July 2015, Cellceutix reported the outcome of a successful End-of-Phase 2 Meeting with the FDA, during which the agency provided input on the Company's proposed phase 3 program. This meeting was a significant milestone for Cellceutix and it triggered the start of phase 3 activities. An agreement was reached in conducting two randomized, well-controlled phase 3 non-inferiority studies, comparing Brilacidin to an approved ABSSSI regimen, with an interim analysis as part of the first study. In addition, and in part related to the novelty of Brilacidin as a completely new class of antibiotic, the FDA requested additional information before the start of the first phase 3 study. Cellceutix is pleased to announce that it has completed this research, compiled the requested information and is submitting it, along with the final protocol for the clinical studies, in the request for a SPA.
A Special Protocol Assessment is a written agreement between the FDA and a drug sponsor detailing the clinical trial design, endpoints and other clinical trial facets that can be used to support regulatory approval, thereby potentially reducing the risk of bringing a drug to market. In the SPA request, Cellceutix is including its choice of comparator for the phase 3 program, consisting of intravenous vancomycin with an option to switch to oral linezolid after three days of therapy. This is considered conventional therapy for ABSSSI and is the same comparator used in the phase 3 program for a recently approved ABSSSI drug.
"Submission of the SPA request is an important milestone in initiating the phase 3 studies of Brilacidin. Using this process helps to ensure harmony with the FDA on trial design and endpoints for this first-in-class antibiotic that we believe has the opportunity to deliver a meaningful impact to ABSSSI patients with a reduced likelihood of resistance developing compared to competitors," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We want to enter this market as we believe with the right partner or distributor, a successful trial resulting in an FDA approved Brilacidin for ABSSSI, it could be a market leader and potentially generate hundreds of millions of dollars annually."
Alerts:
Cellceutix Releases Data Used in Receiving FDA Orphan Drug Designation of Kevetrin for Pancreatic Cancer
BEVERLY, MA--(Marketwired - January 22, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today released information collected from research of Kevetrin for pancreatic cancer. The data was submitted to the U.S. Food and Drug Administration (FDA) as part of an application for an Orphan Drug designation for the indication, which was approved and disclosed yesterday, January 21, 2016.
The laboratory work was a collaborative effort between Cellceutix and pancreatic cancer specialists at a world renowned clinic headquartered in Rochester, Minnesota (the "Clinic"). Cellceutix and the Clinic also collaboratively filed an application for a grant for a clinical trial of Kevetrin for pancreatic cancer.
Preclinical data
In vitro studies with the human pancreatic carcinoma cell line (MIA PaCa-2), which carries the R248W p53 mutation, showed that Kevetrin induced PARP cleavage, down regulated expression of HDAC2, HDAC6, c-Myc and showed synergistic induction of apoptosis in combination with doxorubicin.
In vitro Western blot studies showed that Kevetrin induced p21, the p53 target gene, in MIA PaCa-2 cells.
Poly ADP ribose polymerase (PARP) is involved in DNA repair and helps cells to maintain their viability. Cleavage of PARP serves as a marker of cells undergoing apoptosis. Kevetrin strongly induced PARP cleavage in MIA PaCa-2 cells within 24 hours. When doxorubicin was incubated in combination with Kevetrin, there was a synergistic increase in apoptosis. This suggests that proficient efficacy with lower toxicity may be achieved.
Histone deacetylase (HDAC) has been found to be dysregulated in many cancers. Upregulation of HDAC2 and HDAC6 is associated with advanced stage and poor prognosis. In the research, Kevetrin downregulated expression of both HDAC2 and HDAC6 in MIA PaCa-2 cells.
In vivo efficacy of Kevetrin in the pancreatic MIA PaCa-2 xenograft model showed that tumor volumes were significantly reduced by 82% during 3 weeks of dosing at 200mg/kg. In a separate experiment when Kevetrin alone was dosed at 150mg/kg the tumor volume was reduced by 54%. The combination of Kevetrin and irinotecan further reduced tumor volumes by 88% showing synergistic activity.
Weight changes observed during the daily dosing regimen suggest the combination of Kevetrin and Irinotecan is well-tolerated while being very efficacious in the animal model.
Clinical data
A Phase 1 clinical study was conducted with Kevetrin administered once weekly for 3 weeks with an off-week between cycles. Only one patient with pancreatic cancer was enrolled in the trial. The patient, who was diagnosed with pancreatic cancer received four full cycles of Kevetrin. Tumor measurements showed stable disease for more than three months.
Pancreatic Cancer
Last year, an estimated 48,960 adults (24,840 men and 24,120 women) in the United States were diagnosed with pancreatic cancer. It is estimated that 40,560 deaths (20,710 men and 19,850 women) from this disease occurred. Pancreatic cancer is the eighth most common cancer in women and the fourth leading cause of cancer death in men and women. A notoriously difficult disease to treat, pancreatic cancer has a five-year survival rate of only 7.2 percent.
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NEWS
]Cellceutix Receives FDA Orphan Drug Designation for Kevetrin for the Treatment of Pancreatic Cancer
BEVERLY, MA--(Marketwired - January 21, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that today we received the letter from the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to Kevetrin for the treatment of pancreatic cancer. The work underscoring the new designation was conducted by Cellceutix scientists in collaboration with pancreatic cancer specialists at a world renowned clinic headquartered in Rochester, Minnesota, in preparation for a recently filed grant application.
"Receiving another Orphan Drug designation for Kevetrin, along with the previously announced designation for ovarian cancer, is an important milestone in our strategies for Kevetrin and emphasizes the possibilities of a unique drug like Kevetrin's use in hard-to-treat diseases," commented Leo Ehrlich, Chief Executive Officer at Cellceutix.
Last year, an estimated 48,960 adults (24,840 men and 24,120 women) in the United States were diagnosed with pancreatic cancer. It is estimated that 40,560 deaths (20,710 men and 19,850 women) from this disease occurred. Pancreatic cancer is the eighth most common cancer in women and the fourth leading cause of cancer death in men and women. A notoriously difficult disease to treat, pancreatic cancer has a five-year survival rate of only 7.2 percent.
The FDA's Orphan Drug Designation program allows special incentives for sponsors planning to test a product for use in a rare disease or condition, defined as affecting fewer than 200,000 people in the United States. These incentives include federal grants, tax credits, and reduced filing fees during development or at the time of application for marketing approval. If approved for commercialization by the FDA, the product may qualify for seven years of marketing exclusivity in the United States.
Alerts:
Brilacidin Lyophilized as Cellceutix Prepares to Bring First New Class of Antibiotic to Phase 3 Trials in More Than 20 Years
http://finance.yahoo.com/news/brilacidin-lyophilized-cellceutix-prepares-bring-151331869.html
BEVERLY, MA--(Marketwired - January 14, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that manufacturing, lyophilization and filling of vials is now complete in preparation for the planned Phase 3 trials of Brilacidin for Acute Bacterial Skin and Skin Structure (ABSSSI) infections caused by Gram-positive bacteria. The vials of Brilacidin are now in the inspection and quality control (QC) stage. The Company is preparing for submission the final protocol for the trial per guidance from the U.S. Food and Drug Administration (FDA) received at the end-of-phase 2 meeting.
With the vials being filled, a global Contract Research Organization (CRO) selected, and the final protocol nearing completion, the vast majority of the work has been finished in preparation for the pivotal Phase 3 trials of Brilacidin for ABSSSI. Cellceutix is almost ready to make history by becoming the first new class of antibiotic to enter a Phase 3 clinical trial for ABSSSI in more than two decades.
"I'd also like to address the amended complaint by The Rosen Law Firm, pertaining to the ABSSSI Phase 3 trials," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Using Durata Therapeutics as an example, Rosen alleges that costs for the trial will be a grotesquely over-estimated $145 million. It's a completely inappropriate example. Investors should remember that we have former Durata executive Dr. Ronald Trust as a consultant for the trial, and our Head of Clinical Operations, Edward Walters, is experienced in taking drugs through Phase 3 and getting drugs FDA approved. Many may be unaware that Cellceutix did not use a full service CRO for our Phase 2 ABSSSI study nor the Phase 2 psoriasis study now nearing completion. This likely saved Cellceutix millions of dollars compared to other companies. For the Phase 3 ABSSSI study we will use a global CRO. To that point, we have completed negotiations with a highly recognized global CRO and have a contractual proposal for costs that are many multiples less than that amount Rosen incredibly asserts. With our cash on hand, our commitment from Aspire Capital, and our shelf registration, we believe we have the funding options subject to market conditions, to not only complete the Phase 3 trial of Brilacidin for ABSSSI, but also continue other clinical trials and pre-clinical research. Investors are encouraged to read Cellceutix budgets as they appear in our filings. We have always operated at a very minimal burn rate compared to peers. I will not go into more detail at this point regarding Rosen's complaint as it is in litigation, but I assure you that Cellceutix and our counsel consider it extremely frivolous and feel that there is a strong case for dismissal, sanctions and other legal actions against Rosen and the plaintiff for filing this lawsuit."
Cellceutix Invites All to Attend Its Live Webcast of Company's Presentation at Biotech Showcase 2016
http://finance.yahoo.com/news/cellceutix-invites-attend-live-webcast-205438133.html
BEVERLY, MA--(Marketwired - January 05, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today announces that the Company will be presenting a corporate overview at the Biotech Showcase™ 2016 investor and networking conference. The upcoming event is being held January 11-13, 2016 in San Francisco, CA at Parc 55 San Francisco, Union Square. The event is expected to bring together 2,100+ attendees representing the life science industry's most enterprising and pioneering biotech companies and major players in the drug development arena.
Cellceutix will be presenting on Monday, January 11 at 3:00 PM local time (Pacific time) in Room Powell.
Cellceutix encourages shareholders and other investors to participate in this presentation by accessing the live webcast through the following link: http://edge.media-server.com/m/p/sfwn34cf. Note that if you are unable to listen to the live webcast, the webcast replay will be available approximately 2 hours after the presentation ends and is accessible for 3 Months
Sign-up for email alerts to be notified immediately when the presentation is available and for all notifications on developments from the Company at: http://cellceutix.com/email-alerts/#sthash.VNkn7FY9.dpbs.
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Contact:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich
When I hear freeze drying, I think of the Sanka coffee commercials
Cellceutix Responds to Rosen Law Firm
Beverly, MA–(Marketwired – October 22, 2015) - Cellceutix Corporation (OTC: CTIX), Cellceutix was created to tackle some of the worst diseases known to man. We are a company that firmly believes in the strength of our science and technology. It is our science that gives us the belief that we will be successful and that our shareholders will be rewarded. We currently have multiple clinical trials going on across 3 separate drugs; not many companies our size can boast of that. We understand that because of our success we can be targeted by those who can manipulate financial markets using false information, which is why we are now fighting vigorously to set the record straight. We are undeterred and will continue on our mission to bring our promising pipeline to fruition and bring new life saving therapies that this world needs. We would like to share the below excerpted letter the Company’s legal counsel, the Ashcroft Law Firm led by Michael J. Sullivan, former United States Attorney for the District of Massachusetts, sent today to Rosen Law Firm to demonstrate our commitment in fighting these fraudulent charges and continuing on our important lifesaving work.
The Company will vigorously seek out those who are illegally manipulating the Company’s stock price.
ASHCROFT SULLIVAN
October 22, 2015
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
Re: Demand to Withdraw Complaint and Dismiss Class Action
U.S. District Court (S.D.N.Y) Case No. 1:15-cv-7194 (KPF)
Dear Mr. Kim:
The Ashcroft Law Firm (“ALF” or the “Firm”) has been retained by Cellceutix Corporation (“Cellceutix” or the “Company”) in connection with the above-referenced matter. This letter is to inform you that, in the event you fail to dismiss this matter within the safe harbor under Rule 11, we will seek a dismissal and sanctions against both you and the Rosen Law Firm, P.A., for, among other things, recklessly filing a frivolous lawsuit and, although obligated to do so, failing to conduct reasonable due diligence prior to filing your complaint.
You have conceded in both your complaint and amended complaint that the factual allegations are based solely upon a “report” posted on the internet. What you fail to disclose in the complaint is that the “report” was authored by an anonymous third party who was a short seller of the stock. As we discuss below, you lacked a legitimate basis in law or fact to rely upon the content of the “report” to file your lawsuit. Indeed, even a modest due diligence on your part would have revealed that the claims in that “report” – which you relied upon and subsequently reproduced as factual allegations of your own – were demonstrably false.
Not surprisingly, our client has suffered significant damages (including a substantial diminution in its stock price) as a result of the initial posting of the false “report” referenced above. Those losses, however, have been overshadowed by the catastrophic damages that have come as a direct result of your improper decision to issue a so-called “Equity Alert” and file a class action lawsuit. Your actions also have jeopardized the profound public interest in the development of life-saving drugs.
Please note that this letter should be considered as a formal request to preserve all paper and electronic documents and data relevant to this dispute, including, but not limited to those related to the filing of the complaint in the above-referenced matter, the due diligence you claimed to have conducted prior to filing the complaint, and any communications you may have had with any party related to this dispute, including, as discussed immediately below, Mako Research, Seeking Alpha, Pump Terminator, Pump Stopper, any purported class member or shareholder, or any persons or entities associated with them.
Background
Cellceutix, headquartered in Beverly, MA, is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. The Company owns the rights to numerous drug compounds, and has clinical trials underway, including at Harvard University’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center. See “Cellceutix CORPORATE FACT SHEET.” June 2015. 21 Oct. 2015. <http://cellceutix.com/wp-content/uploads/2015/06/Cellceutix-Fact-Sheet-June-2015-flattened-1.pdf>.
The website www.seekingalpha.com (“Seeking Alpha”) has been described as “a virtual bulletin board and as an open discussion forum where people can publish commentary and articles covering U.S. financial markets.” Matter of Nanoviricides, Inc. v Seeking Alpha, Inc., 2014 NY Slip Op 31681(U) (Sup Ct, New York County) (June 26, 2014), at p. 2. It is “overwhelmingly comprised of posts by third-party sources.” Id.
Mako Research is the pseudonym taken by an anonymous user who, among other things, is responsible for preparing questionable “reports” on various securities in which it is a short seller. Short sellers operate by speculating that the price of a security will decrease, and, as such, “have an obvious motive to exaggerate the infirmities of the securities in which they speculate.” See In re Longtop Financial Technologies Limited Securities Litigation, 910 F.Supp.2d 561, 577-78 (S.D.N.Y. 2012).
For the past several months, Mako Research has been successful in submitting several of its sensational “reports” to Seeking Alpha for posting. These “reports” include:
• “Ocata: Dilution Imminent, SEC Investigation Potentially Underway, Office Appears Empty, Price Target $0.00” (Wed, Sep. 23, 2015);
• “Digital Turbine: Rush For The Exits Creates Liquidity Crisis, Enduring Overhang (Tue, Sep. 15, 2015);
• “Digital Turbine: Strong Sell - Ties To Stock Manipulators, Obsolete Technology, Massive Lock-Up Expiration Just Days Away” (Wed, Sep. 2, 2015);
• “Ocata Therapeutics: Insider Enrichment, Failed Science, Long History Of Fraud Ties, 77% Downside” (Wed, Aug. 19, 2015);
• “LifeLogger: Ties To Stock Promotions, 'Pump-And-Dump' Schemes, Price Target Zero” (Mon, Aug. 10, 2015); and
• “Cellceutix: Empty Office, Unviable 'Science', Misleading Disclosures, 96% Downside” (Thu, Aug. 6, 2015).
In each of these “reports,” Mako Research states that it is a short seller of the security that is the subject of the article. A cursory review reveals that there are a number of similarities in the content of the “reports.”
For example, multiple “reports” make an identical claim that the target company’s office is empty (company “is run out of what appears to be an empty office building” and “[a] visit to [the company’s] office revealed an apparently empty office during business hours”). Several articles likewise make a similar claim that the company is associated with questionable individuals (company “has a long history of ties to people accused of a range of securities violations and fraud” and company “has a long history of ties to people accused of a range of securities violations and fraud”). Multiple “reports” further claim that the target company’s sciences or products are “failed” or “unviable.”
On August 6, 2015, at 10:30 AM, the anonymous Mako Research “report” targeting Cellceutix –Cellceutix: Empty Office, Unviable 'Science', Misleading Disclosures, 96% Downside” –appeared on Seeking Alpha. See “Cellceutix: Empty Office, Unviable 'Science', Misleading Disclosures, 96% Downside.” Seeking Alpha. Mako Research, 06 Aug. 2015. 21 Oct. 2015. < http://seekingalpha.com/article/3406365-cellceutix-empty-office-unviable-science-misleading-disclosures-96-percent-downside>. At bottom, the “report” falsely claimed that: (1) Cellceutix is a sham company, without employees or research studies; (2) one of its officers falsely stated receiving his Ph.D. in Pharmacology from Harvard University; (3) the Company’s antibiotic drug candidate Brilacidin is ineffective; and (4) its anti-cancer drug candidate Kevetrin is ineffective.
Two hours later on August 6, 2015, at 12:41 PM, The Rosen Law Firm, P.A., located in New York, NY, released an “Equity Alert” in which it announced that it was “preparing a class action lawsuit to recover losses suffered by Cellceutix investors” as a result of the Company’s materially false and misleading statements. See “EQUITY ALERT: The Rosen Law Firm Announces Investigation of Securities Claims Against Cellceutix Corporation - CTIX.” Business Wire. The Rosen Law Firm, 06 Aug. 2015. 21 Oct. 2015.
Not surprisingly, the Company’s stock price, which opened at $2.47, fell dramatically on news of both the Mako Research “report” and The Rosen Law Firm’s “Equity Alert.” It closed at $1.71, losing approximately 30% of its value.
A review of publicly-available information on the internet reveals that scientists, investors, and reporters immediately challenged the validity of the assertions in the Mako Research “report.”
For instance, Boston Business Journal reporter Don Seiffert visited the Company’s headquarters on August 14, and published an article (complete with photographs) entitled “My visit to Cellceutix, the biotech that a short seller recently called a sham, debunking the claim that Cellceutix is a shell company and is run out of an empty office building.” See Seiffert, Don. “My Visit to Cellceutix, the Biotech That a Short Seller Recently Called a Sham.” Boston Business Journal. N.p., 16 Aug. 2015. 21 Oct. 2015. < http://www.bizjournals.com/boston/blog/bioflash/2015/08/my-visit-to-cellceutix-the-biotech-that-a-short.html>. The article also highlighted a letter that includes “a statement by Richard Scott, former head of the research department at a biotech named PolyMedix that previously worked on one of the three drugs now in development at Cellceutix.” Dr. Scott is now vice president of research at the Fox Chase Chemical Diversity Center in Doylestown, PA.
In that letter, Dr. Scott declares that he “was appalled at the vast number of factual errors and misleading statements presented in the article.” See Scott, Richard W. “Letter to Seeking Alpha.” Cellceutix Corporation RSS. 11 Aug. 2015. 21 Oct. 2015. <http://cellceutix.com/letter-to-seeking-alpha/#sthash.2NvuPo6l.dpbs>. As a researcher and an expert in Brilacidin, he concluded that “the reference to an ‘unviable science’ that appears in the [Seeking Alpha] article’s title and throughout the text as patently untrue,” and that certain “arguments presented in the article that were based on review by an ‘independent scientist with Doctorate in Biochemistry’ as specious and in certain instances laughable.” Id.
Investors and many others likewise posted comments on Seeking Alpha and other websites, similarly voicing their significant skepticism about the Mako Research “report.” They particularly questioned the motivations of the anonymous, short-seller author, observing that there may be a pattern showing an ongoing conspiracy to manipulate stock prices in violation of federal securities laws. (These comments are too numerous to reproduce here, but again, a review of “information readily obtainable on the Internet,” see Complaint, p. 1, would have revealed this information).
The Company itself also released a point-by-point rebuttal to the claims in the “report” on August 7. See Cellceutix News. “Cellceutix Provides Insight to its Four Clinical Trials”. Cellceutix Corporation RSS. Marketwired, 07 Aug. 2015. Web. 21 Oct. 2015. <http://cellceutix.com/cellceutix-provides-insights-to-its-four-clinical-trials-for-the-treatment-of-absssi-completed-phase-2-anti-cancer-phase-1-psoriasis-phase-2-and-oral-mucositis-in-head-and-neck-cancer-patient/#sthash.7RYBLXez.XVbiSnqH.dpbs>.
Fact checking the “report,” the Company demonstrated that the three primary claims made by the anonymous author – namely, that the Company is run out of an empty office building, Brilacidin is ineffective, and Kevetrin is ineffective – were patently untrue. The Company’s release discussed in painstaking detail numerous scientific errors in the “report” that would give any reasonable reader serious doubt as to the authenticity and veracity of both the anonymous author and the “scientist” allegedly hired to review the Company’s drugs.
Nonetheless, you and the Rosen Law Firm moved forward and filed your securities class action lawsuit on September 11, 2015, in the U.S. District Court for the Southern District of New York. The complaint was based exclusively on the anonymous “report” targeting Cellceutix, and contains no information that would show that any independent investigation or any reasonable due diligence was conducted regarding the claims in the anonymous “report.” The putative class consisted of persons who acquired securities between May 10, 2013 and August 6, 2015.
Astoundingly, the complaint (and later the amended complaint) attributes the “report” solely to Seeking Alpha, and wholly fails to mention that the author of the “report” was anonymous, was a short seller of the Company’s stock, and relied on an undisclosed third party for making its key assertions about the efficacy of Cellceutix’s drugs.
The only language in the complaint suggesting that you or the Rosen Law Firm conducted any inquiry as to the law or the facts appears in the first sentence of the document. That sentence claims that the allegations in the complaint were based upon an investigation “which included, among other things, a review of the defendants’ public documents, conference calls and announcements made by defendants, United States Securities and Exchange Commission (“SEC”) filings, wire and press releases published by and regarding Cellceutix Corporation (“Cellceutix” or the “Company”), analysts’ reports and advisories about the Company, and information readily obtainable on the Internet.” Complaint, at p. 1.
Based on our investigation and review of publicly-available documents, this language regarding your claimed due diligence appears to be nothing more than standard, boilerplate language the Rosen Law Firm uses in federal securities class actions complaints. Compare Complaint, pp. 1-2, in Gary Zagami v. Cellceutix Company, et al., U.S. District Court (S.D.N.Y) Case No. 1:15-cv-7194 (KPF) (filed 09/11/15) with Complaint, pp. 1-2, Thuc Pham v. China Finance Online Co. Limited, et al., U.S. District Court (C.D. CA) Case 2:15-cv-04256-PA-E (filed 06/05/15) (showing identical language except for the defendant’s name). Both your complaints also include boiler-plate language that speculates about the evidence that you may later discover to support your-already-filed complaint: “Plaintiff believes that substantial evidentiary support will exist for the allegations set forth herein after a reasonable opportunity for discovery.” Id.
On September 24, the Rosen Law Firm filed an amended complaint adding Gary Zagami, as a new named plaintiff. The Rosen Law Firm also responded to the court’s order regarding notification of the purported plaintiff class, and, on October 7, requested a Cellceutix officer to waive service of the complaint.
At no time prior to filing the complaint or amended complaint did you, the Rosen Law Firm or any of its agents contact the Company or any of its officers to investigate or take steps to corroborate any of the content in the Mako Research “report.”
Applicable Law
Under Rule 11, “an attorney has an affirmative duty to make ‘reasonable inquiry into the facts and the law.’” Perez v. Posse Comitatus, 373 F.3d 321, 324 (2d Cir. 2004)(quoting Bus. Guides, Inc. v. Chromatic Commc’ns Enters., Inc., 498 U.S. 533, 542 (1991)). Liability for Rule 11 violations requires only a showing of objective unreasonableness on the part of the attorney signing the pleading. ATSI Commc’ns, Inc. v. Shaar Fund, Ltd., 579 F.3d 143, 150 (2d Cir. 2009) (citation omitted); see also id. at 152 (“[T]he mandate of the [Private Securities Litigation Reform Act] obviates the need to find bad faith prior to the imposition of sanctions.”).
It is equally well settled that professional responsibilities under Rule 11 are personal in nature, and cannot be satisfied by merely copying or relying on the work product of another, particularly where the allegations are unsupported by any additional information or independent investigation. See Garr v. U.S. Healthcare, Inc., 22 F.3d 1274, 1280 (3d Cir. 1994)(attorneys violated Rule 11 by failing to personally investigate the law and facts underlying a securities-fraud complaint and instead only relying on a newspaper article, another complaint, and another attorney).
Nor can an attorney conclusory allege that future discovery will support the allegations in the complaint. See, e.g., Garr, 22 F.3d at 1279 (“’A shot in the dark is a sanctionable event ….’”) (citations omitted); Rosenman, Colin, Fruend, Lewis & Cohen v. Edelman, 165 AD2d 533 (1st Dept. 1991)(sanctioning an attorney whose motion “promised to furnish additional supporting papers in the future”); Forstman v. Arluck, 149 Misc. 2d 929 (Sup. Ct. Suffolk Co. 1991) (sanctioning a prominent law firm for “employ[ing] a strategy of proceeding to trial and the examination at trial of the defendant ... in the hope that he would provide some previously undiscerned evidentiary predicate on which to base a claim”). This is particularly true where claims of securities fraud are alleged, which must be pleaded with particularity upon filing.
Discussion
Cellceutix demands that you withdraw your complaint immediately and dismiss the class action against it and two of its officers. In the event you decide to move forward with this litigation, we believe it is likely that the court will promptly dismiss the action, and, based on these facts, will impose Rule 11 sanctions on you and the Rosen Law Firm for failing to conduct a reasonable inquiry prior to filing your complaint. We reach these conclusions for the following reasons.
A. It was unreasonable for you to rely upon the content of the Mako Research “report”
At the outset, we note that it was wholly unreasonable for The Rosen Law Firm to rely upon the content of the “report” by Mako Research posted on Seeking Alpha as a basis for filing your complaint. In fact, there were multiple “red flags” raising a clear indicia of unreliability that a reasonable attorney would have recognized and accordingly declined to give any credence to the assertions in the “report.” At a minimum, the content in the “report” should have been viewed with extreme skepticism, thereby heightening the due diligence imposed upon you by the law and professional responsibilities.
First, the “report” author was anonymous. As such, you, as the attorney signing the complaint, would not be in a position to verify any of the factual statements in the “report” personally, or assess the credibility of the author. As you may be aware, New York courts have shown a growing concern to instances where attorneys fail to take adequate steps to verify key statements upon which a complaint is based. See In re Millennial Media, Inc. Securities Litigation, 2015 WL 3443918 (after complaint is dismissed voluntarily, admonishing plaintiffs’ counsel to be far more assiduous in confirming statements relied upon in complaint).
Second, as a short seller of the target company of the “report,” the author is plainly biased. Indeed, it is well understood that short sellers, in the words of one New York court, “have an obvious motive to exaggerate the infirmities of the securities in which they speculate.” See In re Longtop Financial Technologies Limited Securities Litigation, 910 F.Supp.2d at 577-78 (rejecting argument that short seller reports provide a basis for an adequate pleading of scienter in a securities action). This important consideration is confirmed by Mako Research’s own on-line profile on Seeking Alpha, which explicitly states: “You should assume that Mako Research stands to profit in the event the issuer’s stock declines.” See http://seekingalpha.com/author/mako-research.
Third, while the author claims to have hired “an independent scientist to review Cellceutix’s ‘science,’” the name of that individual is kept confidential. Just as is the case with an anonymous author, an attorney accordingly would not have the opportunity to confirm any statements of this alleged scientist – personally and independently – for accuracy. This raises serious concerns and “sits at best uneasily alongside” Rule 11. See In re Millennial Media, Inc. Securities Litigation, 2015 WL 3443918, slip op. at 8-9; see id at 9 (“If the unreasonableness of failing to undertake rudimentary fact-checking with a witness were not intuitively obvious, the growing body of cases chronicling the repudiation by [confidential witnesses] of statements attributed to them in securities class-action complaints would cinch the need to insist upon such care.)”
Fourth, the circumstances surrounding how and where the “report” was posted likewise strongly militates against relying on its content. In fact, as one New York court concluded in a pre-action disclosure case, the content of similar “reports” should be better treated as opinion, not fact:
As an initial matter, Seeking Alpha’s website’s tagline is “Read. Decide. Invest.” This clearly gives the impression that the website is designed to give people a place to express their opinions and for the reader to then form his or her own assumptions based on the posted articles. Further, the articles published on the website are almost exclusively published by third-parties and not actual reporters. Indeed, the article herein at issue was posted by an anonymous third-party user. Thus, readers are likely to give less credence to the articles found on this website and view the assertions in the articles, like the one herein at issue, with some skepticism and to treat its contents as opinion rather than fact.
Matter of Nanoviricides, Inc. v Seeking Alpha, Inc., 2014 NY Slip Op 31681(U), at pp. 9-10. In this light, it stands to reason that the caution to be exercised by a law firm filing a complaint should be substantially more pronounced than that of a mere reader, especially given the professional responsibilities and serious consequences involved with a putative securities class action.
Fifth, even a cursory review of Seeking Alpha’s vetting and submission policies, which are applicable to anonymous authors, should have strongly cautioned against relying upon the content of the “report.” Specifically, that review would show that Seeking Alpha policies do not include “accuracy” as a factor or characteristic for consideration, and editors apparently do nothing to substantiate any of the assertions in the article:
Our editorial team reviews the article to determine whether it’s appropriate for our audience. We score submissions (internally) on three characteristics: a) Convincing: What's the author's thesis? Does he do a good job of convincing the reader? b) Actionable: Is the article material to investors in an obvious way? c) Well-presented: readers want content that is clear, focused, and easily understandable.
See Hoffman, Eli. “How Much Does Seeking Alpha Pay Its Contributors?” Seeking Alpha. N.p., 10 Apr. 2014. 21 Oct. 2015. <http://seekingalpha.com/article/2134803-how-much-does-seeking-alpha-pay-its-contributors>; see also “POLICY ON ANONYMOUS CONTRIBUTORS” Seeking Alpha. 21 Oct. 2015. <http://seekingalpha.com/page/policy_anonymous_contributors>. (“Seeking Alpha holds our anonymous contributors to the same compliance and biographical standards as contributors who write under their own name.”).
In this light, it is unreasonable for you to assume that because it was posted on Seeking Alpha, the “report” had some degree of credibility. In fact, as discussed above, New York law makes clear that the content of such articles or “reports” should be viewed with skepticism. Matter of Nanoviricides, Inc. v Seeking Alpha, Inc., 2014 NY Slip Op 31681(U), at pp. 9-10.
For all of these reasons, it was reckless for you to rely upon the content of the “report,” and you instead should have approached each and every of the assertions with extreme skepticism. In fact, given all of the “red flags” or indicia of unreliability associated with the “report,” your professional obligations compelled you to take even greater steps to corroborate the assertions therein, which, as we discuss below, you apparently did not do.
B. It seems evident that a reasonable inquiry was not conducted because even a modest investigation would have shown that the “report” allegations were false
Unfortunately for Cellceutix, rather than seeking to corroborate the assertions in the “report,” it seems evident that you failed to conduct a reasonable inquiry prior to including them as facts in the complaint. We reach this conclusion because even a modest investigation would have shown that they were false.
The following chart demonstrates how a reasonable inquiry would have revealed that the allegations in the “report” and included in the complaint were false. It also suggests that the claim made by the Rosen Law Firm in the first sentence of its complaint regarding the alleged steps it took to gain personal knowledge of the allegations (quoted below) may likewise have been misleading to the court.
Allegation in Complaint:
¶23: “… Cellceutix is run out of what appears to be an empty office building … it appears that this is nothing more than a shell corporation”
¶22: “Defendant Menon did not earn his PhD in Pharmacology from Harvard University”
¶22: “Brilacidin is not effective”
¶25: Brilacidin is not effective in combating and treating: (1) ABSSSI; (2) EBSL Enterobacteriaceae; and (3) gram-negative bacteria, such as S. aureus and E. coli.
¶25: “Incidence of sensory nerve symptoms, such as numbness and tingling of the extremities and elevated blood pressure due to unknown problems were reported as serious adverse events in 65-87% of Brilacidin-treated patients.” (emphasis added)
¶22: “Kevetrin does not activate the p-53 gene, which is a tumor suppressor”
¶26: “Kevetrin’s untold story: It does not stop cancer stem cells”
¶26: “Kevetrin’s ineffective clinical trial design”
What a Reasonable Inquiry Would Have Revealed:
1. Review of “information readily obtainable on the Internet” prior to filing the complaint would have revealed the August 14 Boston Business Journal article “My visit to Cellceutix, the biotech that a short seller recently called a sham,” demonstrating the allegation was false:
2. http://www.bizjournals.com/boston/blog/bioflash/2015/08/my-visit-to-cellceutix-the-biotech-that-a-short.html.
3. Review of “the defendants’ public documents,” “announcements made by defendant,” and “press releases published by and regarding Cellceutix” would have revealed the extensive rebuttal by the Company (which included photographs) showing the allegation was false:
4. http://cellceutix.com/cellceutix-provides-insights-to-its-four-clinical-trials-for-the-treatment-of-absssi-completed-phase-2-anti-cancer-phase-1-psoriasis-phase-2-and-oral-mucositis-in-head-and-neck-cancer-patient/#sthash.7RYBLXez.XVbiSnqH.dpbs
5. Review of “United States Securities and Exchange Commission (‘SEC’) filings” would have shown that going back to 2010, the Company’s 10-Ks have disclosed that “he earned his PhD in Pharmacology from Kerala University”:
6. http://www.sec.gov/Archives/edgar/data/1355250/000135525010000023/form10k.htm (2010)
7. These 10-Ks cover the period of time of the putative class, namely purchasers between May 10, 2013 and August 6, 2015.
8. Review of “information readily obtainable on the Internet” would have revealed that Brilacidin has not failed any clinical trials nor has the FDA taken any adverse position with respect to future approval.
9. To the contrary, review of “information readily obtainable on the Internet” (specifically, ClinicalTrials.gov) would have revealed detailed information on the “Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections,” see https://clinicaltrials.gov/ct2/show/NCT02052388?term=cellceutix&rank=5, and would revealed that the study was considered a clinical success, a fact reported at the at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), a global peer-reviewed meeting of academic experts, scientists, and regulators, see http://cellceutix.com/wp-content/uploads/2014/06/A-Randomized-Double-Blind-Study-Comparing-Single-Dose-and-Short-Course-Brilacidin-to-Daptomycin-in-the-Treatment-of-Acute-Bacterial-Skin-Skin-Structure-Infections-ABSSSI1.pdf
10. Review of “announcements made by defendant,” and “press releases published by Cellceutix” would have revealed independent scientific evidence showing multiple scientific inaccuracies – including that the clinical trials involve gram-positive bacteria, rather than gram-negative bacteria – and that the allegation regarding inefficacy is false:
11. See http://cellceutix.com/cellceutix-provides-insights-to-its-four-clinical-trials-for-the-treatment-of-absssi-completed-phase-2-anti-cancer-phase-1-psoriasis-phase-2-and-oral-mucositis-in-head-and-neck-cancer-patient/#sthash.7RYBLXez.XVbiSnqH.dpbs
12. Review of independent scientific literature would reveal that Brilacidin recently completed a phase 2b clinical trial to treat patients with ABSSSI infections caused by S. aureus and demonstrated clinical efficacy and safety in all evaluated doses without any serious adverse events.
13. Contrary to your knowingly false allegations, no treatment related “serious adverse events” (an important term of art) were found in the recent study.
14. See http://cellceutix.com/wp-content/uploads/2014/06/A-Randomized-Double-Blind-Study-Comparing-Single-Dose-and-Short-Course-Brilacidin-to-Daptomycin-in-the-Treatment-of-Acute-Bacterial-Skin-Skin-Structure-Infections-ABSSSI1.pdf (at page 20)
15. Review of “information readily obtainable on the Internet” would have revealed that Kevetrin has not failed any clinical trials nor that the FDA has taken any adverse position with respect to future approval.
16. Review of “announcements made by defendant,” and “press releases published by Cellceutix” would have revealed independent scientific evidence showing multiple scientific inaccuracies – including that the drug is in Phase I clinical trial, not Phase II, has not been tested on cancer stem cells, and that the trial design was a collaboration with Dana Farber – and that the allegation regarding inefficacy is false:
17. http://cellceutix.com/cellceutix-provides-insights-to-its-four-clinical-trials-for-the-treatment-of-absssi-completed-phase-2-anti-cancer-phase-1-psoriasis-phase-2-and-oral-mucositis-in-head-and-neck-cancer-patient/#sthash.7RYBLXez.XVbiSnqH.dpbs
A visit by an investigator (or any person) to Cellceutix headquarters would have shown that the allegation was false.
We further note here that had you investigated the most simple, yet sensational, allegation found in the “report” – which was included in the “report” title, namely, that Cellceutix is run out of an “Empty Office” – you would have immediately found it false. That would have and should have placed the credibility of the entire “report” in doubt, and at a minimum, placed you on notice that the subsequent allegations in the “report” could not be trusted and had to be thoroughly and independently verified, which you apparently did not do.
C. No lawyer could have formed a reasonable belief that the complaint was well grounded in fact
Based on the foregoing, no lawyer could have formed a reasonable belief that the complaint was well grounded in either the fact or the law.
We are confident that the court will conclude that simply copying and pasting an anonymous, obviously biased posting from what is essentially an internet message board does not constitute a personal, reasonable inquiry that would satisfy Rule 11. Attorneys who have relied on far more objectively reputable sources have been sanctioned for less. See Garr, 22 F.3d at 1280 (attorneys in a securities-fraud case violated Rule 11 by relying on a newspaper article, another complaint, and another attorney).
This is even more likely given at least one New York court’s view that articles or “reports” just like these should be met with skepticism by reader and treated merely as opinion. Matter of Nanoviricides, Inc. v Seeking Alpha, Inc., 2014 NY Slip Op 31681(U)(Sup Ct, New York County)(June 26, 2014), at 9-10
We also note here that there was no time constraints or emergency that would have justified anything short of a thorough due diligence, particularly given the numerous red flags inherent in the “report.”
D. No lawyer could have formed a reasonable belief that the complaint was well grounded in law
In addition to the factual shortcomings underlying the complaint, its legal allegations are likewise deficient in at least three respects. These, among other things, would be the subject of a motion to dismiss the action, which more than likely will be successful.
First, the complaint fails to allege and show that venue is proper. As you no doubt are aware, venue with regard to securities law claims under the Securities Exchange Act is controlled exclusively by the venue provision of the Act, without regard to the general venue provisions. See SST Global Technology, LLC v. Chapman, 270 F.Supp.2d 444 (2003); 15 U.S.C. §78aa; 28 U.S.C. §1391(b).
Cellceutix is located in Massachusetts. It does not transact business in New York. None of the statements you recklessly claim as false are alleged to have taken place in New York. In fact, apart from the Rosen Law Firm’s address, there is nothing in the complaint to suggest that New York (let alone the Southern District of New York) is related to this dispute and that venue is proper.
Second, for many of the reasons above, the allegations in the complaint regarding securities fraud fail because they insufficiently plead falsity. Moreover, the Company has at all times properly characterized the status of its drugs and clinical trials, and courts have routinely dismissed securities claims on that basis. See Kleinman v. Elan Corp., plc, 706 F.3d 145 (2d Cir. 2013)(rejecting plaintiffs’ allegations that positive statements regarding the results of a failed Phase II drug trial were actionable); accord In re Kery Biopharmaceuticals, Inc., Securities Litigation, slip op. at 1 (“It would indeed be unjust and could lead to unfortunate consequences beyond a single lawsuit if the securities laws become a tool to second guess how clinical trials are designed and managed. The law prevents such a result; the Court applies that law here, and thus dismisses these actions.).
Third, the allegations in the complaint regarding securities fraud fail because they insufficiently plead scienter, the mental state embracing an intent to deceive, manipulate, or defraud. See Tellabs, Inc. v. Ylakor Issues & Rights, Ltd., 551 U.S. 308, 319, 323 (2007). In fact, the complaint does not contain any particular alleged facts that would give rise to a strong inference of scienter. Moreover, under New York law, allegations limited to the type of “corporate profit” motive possessed by most corporate directors and officers do not suffice. Kalnit v. Eichler, 264 F.3d 131, 138 (2d Cir. 2001).
In sum, just as the allegations in the complaint lack a well-founded basis in fact, so too do its legal claims. As such, we have no hesitation concluding that should this case move forward, a court would dismiss the claims as a matter of law, and impose sanctions in the process.
Deleted….
On that note, we wish to inform you that – and to be clear, we do not by any means suggest that the Rosen Law Firm has been or is engaged in any impropriety beyond filing a frivolous complaint – we anticipate providing this communication, as well as intelligence that we have uncovered showing a potential conspiracy to commit securities manipulation, to regulatory and enforcement officials at both the state and federal level.
Deleted….
ASHCROFT SULLIVAN
Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Contact:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich
info@cellceutix.com
The Clowns will be the first in line at the shareholders meeting in a few years too. They will be the guys shaking Leo's hand, telling him "we knew you could do it", "never lost faith in you"
Cellceutix Announces Brilacidin Data to Be Presented by ICPD at the Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC)
Material Transfer Agreement Being Extended for Additional Research of Brilacidin to Prevent Infection in Implants
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Marketwired
Cellceutix
September 16, 2015 7:40 AM
BEVERLY, MA--(Marketwired - September 16, 2015) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to report that results of its recently completed pharmacokinetic/pharmacodynamic (PK/PD) model entitled "Population Pharmacokinetics (PPK) of Brilacidin (BRI) in Healthy Subjects and Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)" will be presented as a "poster walk" at the Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy and 28th International Congress of Chemotherapy from 12:00 to 2:00 pm PDT on September 18 in San Diego, CA. The oral presentation will be given by the lead author of the poster, Dr. Scott Van Wart, of the Institute for Clinical Pharmacodynamics (ICPD). The poster will be available on the Cellceutix website beginning 12:00 pm PDT Friday, September 18, 2015.
Using data from three Phase 1 and two Phase 2 studies in acute bacterial skin and skin-structure infection (ABSSSI) patients, a population pharmacokinetic (PPK) model for BRI was developed to describe the time-course of BRI in plasma and to identify significant predictors of BRI PK. "We are pleased that this important information has been accepted for an oral poster presentation," said Dr. Daniel Jorgensen, Chief Medical Officer at Cellceutix. "This way, the audience has an opportunity to participate in an interactive question and answer discussion. More importantly, the audience will learn about state-of-the art modeling techniques that have informed the selection of Brilacidin doses in past Phase 2 studies and future Phase 3 studies."
Dr. Jorgensen added, "There is an urgent need for new classes of antibiotics that are effective in this era of increasing drug resistance. We believe our defensin-mimetics, including Brilacidin, can address this need. The laboratory and clinical data presented at previous academic meetings, along with the newer PK/PD data to be presented at ICAAC, support the continued development of this promising class of compounds. We look forward to sharing these data at the ICAAC meeting."
Separately, Cellceutix is pleased to provide and update on the Material Transfer Agreement (MTA) disclosed in November 2014 with a division of one of the largest U.S. pharmaceutical companies (the "Pharma") for testing Brilacidin as a component of certain implanted devices as a means to prevent infection. Cellceutix has been advised that initial testing is encouraging. The Pharma has requested an extension to the MTA with an additional order to conduct further analysis of Brilacidin for this prophylactic application. The MTA does not cover the pharmaceutical use of Brilacidin for treatment of infections or other diseases. A final contract can only be entered into if and when Brilacidin receives Food and Drug Administration (FDA) approval.
"We feel the MTA extension and add-on order for additional research by such an esteemed organization is further validation of the potential of Brilacidin. These types of collaborations are important in expanding our defensin-mimetic drug discovery program in new verticals and we look forward to results from their testing in the future," concluded Dr. Jorgensen.
Conference starts at 2 PM central, poster will be on the Cellceutix website at 2 PM central as well
BEVERLY, MA--(Marketwired - September 16, 2015) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to report that results of its recently completed pharmacokinetic/pharmacodynamic (PK/PD) model entitled "Population Pharmacokinetics (PPK) of Brilacidin (BRI) in Healthy Subjects and Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)" will be presented as a "poster walk" at the Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy and 28th International Congress of Chemotherapy from 12:00 to 2:00 pm PDT on September 18 in San Diego, CA. The oral presentation will be given by the lead author of the poster, Dr. Scott Van Wart, of the Institute for Clinical Pharmacodynamics (ICPD). The poster will be available on the Cellceutix website beginning 12:00 pm PDT Friday, September 18, 2015.
From today's PR
Using data from three Phase 1 and two Phase 2 studies in acute bacterial skin and skin-structure infection (ABSSSI) patients, a population pharmacokinetic (PPK) model for BRI was developed to describe the time-course of BRI in plasma and to identify significant predictors of BRI PK. "We are pleased that this important information has been accepted for an oral poster presentation," said Dr. Daniel Jorgensen, Chief Medical Officer at Cellceutix. "This way, the audience has an opportunity to participate in an interactive question and answer discussion. More importantly, the audience will learn about state-of-the art modeling techniques that have informed the selection of Brilacidin doses in past Phase 2 studies and future Phase 3 studies."
Dr. Jorgensen added, "There is an urgent need for new classes of antibiotics that are effective in this era of increasing drug resistance. We believe our defensin-mimetics, including Brilacidin, can address this need. The laboratory and clinical data presented at previous academic meetings, along with the newer PK/PD data to be presented at ICAAC, support the continued development of this promising class of compounds. We look forward to sharing these data at the ICAAC meeting
Should have done that back in May
now we can get back to discussing why the Kevetrin P1 trial has taken as long as my sophomore year in college...
I do and when I click on the name
George Evans here is what comes up
George Evans <info@cellceutix.com>
I sent my original email to the info@cellceutix email address off the website. Leo answered me from his personal account.
Since I started this, let me see if I can clear this up
I emailed Leo this morning asking about George Evans and below is his reply, also attached is the whole email chain.
From: Leo Ehrlich [mailto:leo@cellceutix.com]
Sent: Thursday, August 27, 2015 12:08 PM
Subject: Re: question from the quarterly update/George Evans
Sorry. I was cc-ing info@cellceutix,com and I must have been using an old computer that associated that address with the name George Evans, our former CEO. Regardless it didn't go to George and was only cc'd to info@cellceutix.com
Best,
Leo Ehrlich | CEO |
On Thu, Aug 27, 2015 at 12:19 PM, Greg wrote:
Good Morning Leo
This is the email that brought up the question about George Evans, it was a reply from you to me back in May
He was copied on the reply
Is this the same George Evans that used to be the CEO ?
Thanks
Greg
From: Leo Ehrlich [mailto:leo@cellceutix.com]
Sent: Tuesday, May 19, 2015 12:30 PM
To: Greg
Cc: George Evans
Subject: Re: question from the quarterly update
Hi Greg,
Yes. That information will on our next press release.
Best wishes,
Leo Ehrlich | CEO |
On Tue, May 19, 2015 at 1:17 PM, Greg wrote:
Good afternoon
Can you tell me when we will received more information on the item in red below? Has the IRB met?
The current protocol was originally designed to evaluate 40 patients. 39 patients have been treated to date, meaning that one patient will receive the 750 mg/m2 to complete enrollment per the original trial design. Because of the stepwise increases in Kevetrin dose that have occurred, and the fact that a maximum tolerated dose has not been identified, Cellceutix has requested amendment of the protocol to allow treatment of additional patients at higher doses of Kevetrin. The Company has been advised that this request has been scheduled for the next Institutional Review Board meeting in late April or early May. –
See more at: http://cellceutix.com/cellceutix-provides-corporate-update/#sthash.4Qxjm8Kg.dpuf
Thank you
Most often the usual explanation down here at the sleazy end of the stock markets is insiders dumping their free shares, but in the case of CTIX today it may simply be Mr. Market being spooked again by today's utterly unprofessional vapor PR.
What nonsense!
Unless of course you would care to post some evidence of such trades?
At that time, it was only 1 person in the 11th cohort. That person completed the original 40 person trial.
From the May 22nd PR
http://finance.yahoo.com/news/irb-approves-additional-enrollment-cellceutixs-110000570.html
The original protocol for the trial specified 40 patients to be enrolled. Due to maximum tolerated dose ("MTD") not yet being identified and data indicating that the effect of Kevetrin on p53, a key tumor suppressor protein often referred to as the "Guardian of the Genome," is dose dependent as expected, Cellceutix requested an amendment to the protocol to continue to evaluate administration of Kevetrin at higher doses. The trial is currently in its eleventh cohort, with one patient (the 40th in the trial) having received two infusions of Kevetrin at 750 mg/m2. The Company has been advised that screening of additional patients is underway and they are expected to be enrolled into the study
750 MG didn't start until late April 2015
The protocol safety committee met on April 13, 2015 to review data for patients treated in the 450 mg/m2 cohort and recommended that the next cohort receive Kevetrin doses of 750 mg/m2 (a 67% increase in dose and 75x the initial dose).
The current protocol was originally designed to evaluate 40 patients. 39 patients have been treated to date, meaning that one patient will receive the 750 mg/m2 to complete enrollment per the original trial design. Because of the stepwise increases in Kevetrin dose that have occurred, and the fact that a maximum tolerated dose has not been identified, Cellceutix has requested amendment of the protocol to allow treatment of additional patients at higher doses of Kevetrin. The Company has been advised that this request has been scheduled for the next Institutional Review Board meeting in late April or early May.
http://finance.yahoo.com/news/cellceutix-provides-corporate-140507963.html
Completed in April PR attached
http://finance.yahoo.com/news/tenth-cohort-completed-cellceutix-clinical-122803268.html
BEVERLY, MA--(Marketwired - Mar 24, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the tenth cohort in the Company's Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center has been completed. Patients in the tenth cohort were treated with 450 mg/m2 of Kevetrin with no adverse events reported.
Cellceutix has been advised that the tenth cohort is being included in the latest testing for the effect of Kevetrin on the biomarker p21, a key downstream protein and proxy for reactivation of the tumor suppressor protein p53. The data on p21 are expected to be received in mid-April.
Cellceutix had several options on the table moving forward with the trial. After meeting with the trial's Principal Investigator and Cellceutix consultants, the Company has decided to take dosing even higher due to the wide bandwidth of Kevetrin and enroll an eleventh cohort. The Safety Committee will meet in the coming weeks to determine the new dosing level, which, theoretically, could be increased up to 100 percent in a bid to define the maximum tolerated dose of Kevetrin.
"This is great news that the tenth cohort has been completed, once again demonstrating the safety of Kevetrin. Our team is excited by the fact that no dose limiting toxicity (DLT) has been seen even at these higher levels, as DLT has historically been a significant hurdle for any biotech targeting p53. As such, we're going to continue to push our novel drug as far as possible for maximum therapeutic effect and to collect the most robust data set possible," commented Dr. James Alexander, Chief Operating Officer at Cellceutix. "We have seen some encouraging data in different types of cancer to date and the eleventh cohort gives us the opportunity to add to our knowledge base in preparation for future clinical studies."
Sign-up for Cellceutix email alerts is available at
http://cellceutix.com/email-alerts/#sthash.VNkn7FY9.dpbs
was mentioned yesterday.
Separately, Cellceutix would like to announce the resignation of James Alexander, MD, MPH as Chief Operating Officer at Cellceutix due to the recent occurrence of a personal medical issue. It was unanticipated, however we are pleased Dr. Alexander will remain a consultant to Cellceutix on Kevetrin on a limited basis going forward.
Which K cohort is Orphan Designation being given for? Would the results from the current cohort be available?
I have a buy order in for 300 shares at $2.68
go ahead and cut yours loose...
That would be great...then people could start complaining about Prurisol instead of uplist..
except for maybe this part....
Cellceutix will be issuing a separate update on the events at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting shortly after its conclusion on Tuesday, June 2, 2015
Tails Gov asked me who the Investor Relations guy was that Leo copied on an email reply from Cellceutix yesterday.
George Evans was the guy
Gov
George Evans was copied on the email
Greg
Sent an email to Cellceutix Investor Relations today
Got an answer back pretty quickly from Leo, he copied the IR guy on the response
I asked if the IRB Board at DF had met, he said yes
I asked when we would get more info on the meeting, he said on our next press release
I remember this as the latest update
http://finance.yahoo.com/news/cellceutix-provides-corporate-140507963.html
We released the positive top-line data from the Phase 2b Brilacidin trial in October 2014. After our initial submission of data from this study to the FDA, the agency requested additional data from the trial. We have gathered microbiologic (MIC) data from bacterial pathogens isolated in the trial, analyzed pharmacokinetic (PK) data, performed pharmacodynamic (PD) modeling, and conducted in-depth evaluations of the safety profile of Brilacidin in comparison to daptomycin in this patient population. We anticipate meeting with the FDA for an End-of-Phase 2 meeting in late June 2015. Upon the FDA accepting our proposals, we will commence Phase 3 trials of Brilacidin for ABSSSI.
Good to know, now we have a reference point when the new ones come out later today
They did..
From the 1-20-2015 Press release
http://finance.yahoo.com/news/cellceutix-reports-spleen-lesion-disappears-120000403.html
Additionally, the Principal Investigators for the Kevetrin trial have requested that the Company start preparing a presentation to be used for an article on the safety and pharmacological effect of Kevetrin on multiple cancer lines as demonstrated in the clinical trial. Cellceutix interprets this recommendation as a very optimistic sign regarding anticipated outcomes for the trial and clinical advancement of Kevetrin.