On September 13, 2016 Cellceutix Corporation (OTCQB: CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, antibiotic, and anti-inflammatory applications, reported a fiscal year-end business update including a timeline of key upcoming milestones (Filing, Annual, CellCeutix, 2015, SEP 13, 2016, View Source [SID:SID1234515120]).

Leo Ehrlich, Chief Executive Officer, commented, "We are extremely pleased with the tremendous progress that we have made, especially within the last 12 months. We have assembled an attractive portfolio of three unique compounds, each of which addresses very large markets and is supported by strong IP protection. To date, we have met all of the primary endpoints in each of our clinical trials, and we have a number of very important milestones upcoming during the course of the next 12 to 18 months. Many of these milestones have the potential to create a substantial inflection (turning) point in our market cap."

Upcoming Milestones

Drug Candidate
Event
Description
Period
Year
Brilacidin
Kevetrin
Prurisol

Clinical Update
Ulcerative Proctitis- Interim analysis Ph2a trial
4Q
2016

Trial Progress
Ovarian Cancer- Initiation Ph2a trial
4Q
2016

Trial Progress
Psoriasis- Initiation Ph2b trial
4Q
2016

Clinical Update
Oral Mucositis- Interim analysis Ph2
1H
2017

Clinical Update
Psoriasis- Interim Analysis Ph2b
1H
2017

Clinical Update
Ulcerative Proctitis- Complete Ph2a trial
1H
2017

Clinical Update
Oral Mucositis- Complete analysis Ph2 trial
2H
2017

Clinical Update
Ovarian Cancer- PoC p53 modulation (Ph2a)
2H
2017

Trial Progress
ABSSSI- Start Ph3 trial
*
2017
____________
*Timetable dependent on reaching SPA agreement with FDA

Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix, commented, "We are making progress advancing Prurisol through the clinical pathway. We completed a Phase 2a trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis in May 2016. The trial successfully achieved its primary endpoint, further validating Prurisol’s potential as a novel oral treatment for psoriasis. On the heels of these data, we are now planning our Phase 2b trial of Prurisol for patients with moderate-to-severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses and we expect to have our interim analysis top-line results in the second quarter of 2017. We believe that the potential safety profile of Prurisol may make this an attractive alternative to Celgene’s OTEZLA, which is on its way to achieving $1 billion in sales within just three years of its launch."

"We are also making headway with our Kevetrin asset, which has shown potent anti-tumor activity. Following our Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, we are now preparing for a Phase 2a trial of Kevetrin for treating late stage ovarian cancer. We anticipate that this trial will start in the fourth quarter of this year. Our plan is to conduct a small trial that will provide the critical data necessary to forge a partnership with a large pharmaceutical company that could potentially fund development of Kevetrin through FDA approval. We are encouraged by the guidance and feedback that we have received from potential partners which are incorporated in our Phase 2a trial design."

"Lastly, we completed our Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, and are moving forward with our Phase 2 clinical trial with Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin has a novel mechanism of action– robust anti-bacterial as well as anti-inflammatory properties. In fact, a single dose of Brilacidin has been shown to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Moreover, we believe that it will demonstrate a broad spectrum of activity in infectious diseases, gastrointestinal and inflammatory diseases, and a variety of dermatological diseases."

Mr. Ehrlich concluded, "To wrap up, the consistent theme across all of our compounds is strong supporting clinical data and a clear path to delivering a meaningful return on investment. We had previously been largely under the radar of Wall Street and institutional investors, but given our success to-date, we are now engaging in a much more aggressive outreach effort. We have a number of important upcoming milestones, that if successful, we believe will drive meaningful value for shareholders."

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On September 13, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), reported that the Company and its collaborators from the University of Texas MD Anderson Cancer Center presented new data in a research poster entitled "Activity of dianhydrogalactitol (VAL-083) in ovarian tumor models, sensitive or resistant to cisplatin" at the 11th Biennial Ovarian Cancer Research Symposium (Press release, DelMar Pharmaceuticals, SEP 13, 2016, View Source [SID:SID1234515118]).

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The data, presented on the evening of Monday, September 12th at the Rivkin Center for Ovarian Cancer in Seattle, Washington, support a distinct mechanism of action for VAL-083 versus platinum-based chemotherapy currently used in the treatment of ovarian cancer.

"We were pleased to present these data, which are highly supportive of VAL-083’s potential as a new therapeutic option for ovarian cancer patients whose treatment is underserved by currently available therapy. We plan to work with our advisors to develop a strategy to advance VAL-083 into clinical trials for the treatment of ovarian cancer, either as a single-agent or in combination with other approved agents," said Jeffrey Bacha, Chairman & CEO of DelMar.

The researchers also reported observations of synergy when VAL-083 was combined with platinum-based chemotherapy or PARP inhibitors and that the potency of VAL-083 is increased when a cell’s homologous recombination ("HR") DNA repair mechanism is impaired, further suggesting that VAL-083-induced DNA lesions are repaired via the HR pathway.

Dr. Dennis Brown, DelMar’s Chief Scientific Officer noted, "These data are important because they provide further support of our previous research suggesting that VAL-083 imparts its anti-cancer activity via double-strand breaks as a result of DNA cross-links at the N7-position of guanine. Homologous recombination is the mechanism generally employed by cells to repair damage resulting from DNA double strand breaks. Deficiencies in HR are a hallmark of many cancers, including ovarian cancers, while normal cells retain HR function. This may explain why VAL-083 has been observed to possess high activity against cancer yet exhibit limited toxicity against normal cells."

In summary,

VAL-083 demonstrated cytotoxic activity against all ovarian cancer cell lines tested and is substantially less dependent on wild-type p53 for cytotoxic activity.
VAL-083 was able to circumvent 70-85% of cisplatin-resistance in an ovarian cancer cell line panel with several known p53 mutations and displays synergy with cisplatin in p53 mutant cell line H1975.
VAL-083 demonstrated synergy with AstraZeneca’s PARP inhibitor Olaparib in ovarian cancer cell line A2780.
The potency of VAL-083 activity was increased when HR was impaired in A2870 cells with BRCA1 knockdown, demonstrating that VAL-083 induced DNA-lesions are repaired via HR.
"Taken together, these results support VAL-083’s potential as a treatment option for ovarian cancer patients failing platinum-based therapy particularly in an HR-impaired setting. They further suggest a potential benefit of therapeutic combination regimens containing VAL-083 plus platinum-based chemotherapy or VAL-083 in combination with a PARP inhibitor such as Olaparib," concluded Mr. Bacha.

VAL-083 is a "first-in-class" small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia in prior clinical trials sponsored by the US National Cancer Institutes both as a single-agent and in combination with other treatments. DelMar recently announced completion of Phase I/II clinical trials with VAL-083 as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The Company plans to advance VAL-083 into a pivotal Phase III clinical trial for refractory GBM and also plans to advance VAL-083 into clinical trials for other solid tumors such as non-small cell lung cancer and ovarian cancer.

In April 2016, the FDA Office of Orphan Products Development (OOPD) granted orphan drug designation for VAL-083 in the treatment of ovarian cancer. VAL-083 had earlier received an orphan designation for glioma and medulloblastoma in the United States and for glioma in Europe.

DelMar CEO to Present Today at 18th Annual Rodman & Renshaw Global Investment Conference in New York

Jeffrey Bacha, DelMar’s president and CEO, will deliver a corporate address today at the 18th Annual Rodman & Renshaw Global Investment Conference. Mr. Bacha’s presentation is scheduled for 10:50-11:15 AM Eastern Time in the Kennedy II Ballroom at the Lotte New York Palace Hotel. A live webcast of the presentation will be available by accessing a link that will be posted on the Company’s website (www.DelMarPharma.com). A webcast replay will be available approximately two hours after the presentation ends and will be accessible for one month.

About Ovarian Cancer

According to Evaluate Pharma, the annual market for ovarian cancer therapies is expected to reach approximately $570 million in 2016, and is projected to 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, as up to 75% of ovarian cancer patients who respond to initial treatment will relapse within approximately 18 months after completing first-line therapy. In published studies, median survival in platinum-resistant recurrent ovarian cancer patients ranged from six to nine months.

On September 12, 2016 Circle Pharma, Inc., reported that it will apply its computational design and synthetic chemistry platform to design and create a physical screening library of novel macrocyclicpeptides (Press release, Circle Pharma, SEP 12, 2016, View Source [SID1234635670]). Once completed, the library is initially expected to comprise several hundred macrocycles that will be designed to potentially disrupt bioactive conformations commonly found in protein-protein interactions known to drive disease processes, and will deploy backbone scaffolds screened in silica for intrinsic cell permeability characteristics. In addition, the design of the library will permit the simple creation of derivative libraries tailored to specific features of a therapeutic target class.

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PfizerInc.(NYSE:PFE) has entered into an agreement with Circle under which Pfizer will provide support for the library build, and Circle has granted Pfizer non-exclusive rights to screen the library against certaintargets. The rights granted to Pfizer exclude specified targets for which Circle has reserved exclusive rights to screen the library.

"This physical library will complement Circle’s target-specific computational design toolkit," said David J. Earp, J.D., Ph.D., Circle’s President and CEO. "We expect to use the library for our internal pipeline discovery work, and we will make it available to all of our collaboration partners in drug discovery."

About Macrocyclic Peptides

Macrocyclic peptides have the potential to provide access to the large proportion of therapeutic targets (estimated at up to 80%) that are considered undruggable with conventional small molecule or biologic modalities. Inparticular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited to this point by the need for a greater understanding of how to design macrocycles with appropriate pharm acokinetics, cell permeability and oral bioavailability. As a result, most clinical-stage macro cyclic peptide drugs address extracellular protein targets because of the challenge of identifying cell permeable macrocycles. The ability to design potent macrocycles with intrinsic permeability is expected to give access to a large number of important therapeutic targets that have been out of reach to this point.

(Filing, 10-K, DelMar Pharmaceuticals, 2015, SEP 12, 2016, View Source [SID:SID1234515115])

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