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 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 12, 2016 PRA Health Sciences, Inc. (NASDAQ: PRAH) and Takeda Pharmaceutical Company Limited (TSE: 4502) reported that the companies have entered into a new partnership agreement under which PRA Health Sciences (PRA) will serve as Takeda’s primary strategic partner to deliver on the company’s pipeline and marketed products clinical development and post-approval needs (Press release, Takeda, SEP 12, 2016, View Source [SID:SID1234515124]).

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"This partnership is a fundamental part of Takeda’s R&D transformation and represents a truly innovative approach to clinical development, unprecedented in our industry," said Andy Plump, M.D., Ph.D., Director, Chief Medical and Scientific Officer at Takeda. "PRA has a reputation for providing tailored sourcing solutions. We believe PRA will be an ideal partner as we focus, deliver and advance our current and future pipeline."

The innovative partnership provides a flexible operating model that combines operational expertise, transferred from Takeda to PRA, with PRA’s wide range of global capabilities. This model is aimed to improve operating efficiencies, drive globalization and reduce fixed infrastructure costs. This flexible approach will facilitate the development of new medicines by focusing resources, teams and activities where needed, an important requirement for an industry-leading, highly agile R&D organization focused on meeting patient needs.

"This partnership is an exciting opportunity for PRA and represents a significant milestone and transformational business opportunity for us," said PRA Chief Executive Officer Colin Shannon. "This is the first time that a pharmaceutical company and a clinical research organization (CRO) have come together to create such a comprehensive business and operational strategy. This partnership model redefines collaboration and is the first of its kind in the CRO industry."

The partnership will enable PRA to utilize its internal resources and expertise to manage an entire pipeline of studies for Takeda, across Phases I-IV and provide Regulatory, Pharmacovigilance and other operational services for both development and marketed product portfolios. The transformation is expected to result in approximately 300 Takeda employees supporting drug development and marketed products to be given the opportunity to transition to PRA in the United States and Europe, subject to appropriate information and consultation with works councils, unions, and employee representatives. Discussion regarding Japan employees is ongoing between Takeda and PRA.

On September 12, 2016 pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, reported a Company update and announced financial results for its fourth quarter and fiscal year ended June 30, 2016 (Press release, pSivida, SEP 12, 2016, View Source [SID:SID1234515126]).

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"Fiscal 2016 was a year of substantial progress for pSivida. We significantly advanced Medidur for posterior segment uveitis toward planned EU and U.S. marketing applications, progressing toward a treatment with the potential to inhibit the disease for three years from a single injection without significant side effects and without systemic therapy," said Dr. Paul Ashton, president and chief executive officer of pSivida. "Additionally, fiscal 2016 marked the first use of our Durasert technology outside of ophthalmology with the commencement of an investigator-sponsored pilot study of a sustained-release implant being developed in collaboration with Hospital for Special Surgery designed to provide long-term pain relief for severe knee osteoarthritis. Also, based on pre-clinical studies completed in fiscal 2016, we commenced the first of two IND-enabling studies for an injectable, bioerodible Durasert insert for sustained delivery of a tyrosine kinase inhibitor (TKI) for treatment of wet age-related macular degeneration."

Business Highlights

The first of the two Phase 3 trials for Medidur for posterior segment uveitis met its primary efficacy endpoint of prevention of recurrence of disease at six months with high statistical significance (p less than 0.00000001, intent to treat analysis) with encouraging safety results.

pSivida’s utilization study of its proprietary, smaller diameter 27-gauge inserter met its primary endpoint, ease of intravitreal administration, showing it facilitated the administration of Medidur compared to the larger diameter inserter.

The European Commission designated Medidur as an orphan medicinal product and the Company plans to submit a European marketing authorization application (MAA) for Medidur under the centralized procedure in the first quarter of 2017 based on data from the single, first Phase 3 trial, the inserter utilization study and the ILUVIEN for diabetic macular edema (DME) trials.

The second Medidur Phase 3 trial is expected to complete enrollment next month. Pending positive results, a U.S. new drug application (NDA) based on both Phase 3 trials is planned for the third quarter of 2017.

An investigator-sponsored pilot study commenced for a Durasert sustained-release implant being developed together with Hospital for Special Surgery that is designed to provide long-term pain relief for severe knee osteoarthritis.

Following the successful results of earlier reported animal studies comparing a TKI insert to an injection of a commercially available biologic indicated for wet AMD, pSivida commenced the first of two investigational new drug (IND)-enabling studies of the TKI insert for wet AMD.

Results of pSivida’s pre-clinical studies of Tethadur reported in July demonstrated that Tethadur could provide prolonged, sustained delivery of Avastin with high drug efficacy. pSivida plans to conduct additional pre-clinical studies seeking to develop Tethadur for ophthalmic and systemic delivery of biologics.

In the first quarter of fiscal 2017, pSivida enhanced its research and product development with the addition of Dario Paggiarino, M.D. as chief medical officer. The Company also closed its U.K. research facility and consolidated all of its research into its state-of-the-art, cGMP U.S. facility coordinated by Dr. Paggiarino in an effort to improve the flow of research to product candidates while reducing overhead.

pSivida replenished its capital resources with a $17.8 million underwritten public offering of common stock earlier in the year.
Results for the Fourth Quarter and Year Ended June 30, 2016. At June 30, 2016, cash, cash equivalents and marketable securities totaled $29.0 million compared to $28.5 million at the end of the prior year. In January 2016, pSivida enhanced its cash position with net proceeds of $16.5 million from an underwritten public offering of its common stock. Net operating cash usage in the fiscal 2016 fourth quarter totaled $4.3 million, the same as the prior quarter. Net operating cash usage is expected to increase during fiscal 2017 compared to fiscal 2016 and to vary from quarter to quarter during the fiscal year, primarily as a result of the amount and timing of payments for Medidur clinical development and regulatory submissions and, in the first quarter, the previously announced U.K. consolidation costs and incentive compensation payments.

Revenues for the quarter ended June 30, 2016 totaled $304,000 compared to $409,000 for the prior year quarter.

Research and development expense increased by $906,000, or 28%, to $4.1 million for the fiscal 2016 fourth quarter compared to $3.2 million for the prior year quarter. This was primarily attributable to increased Medidur CRO and regulatory preparation costs and increased personnel costs, including incentive compensation and contractual severance obligations.

General and administrative expense increased by $245,000, or 10%, to $2.7 million for the quarter ended June 30, 2016 compared to $2.4 million for the prior year quarter. The increase was primarily attributable to higher incentive compensation.

Net loss for the quarter ended June 30, 2016 was $6.4 million, or $0.19 per share, compared to a net loss of $5.1 million, or $0.17 per share, for the prior year quarter.

Revenues for the year ended June 30, 2016 totaled $1.6 million compared to $26.6 million for the year ended June 30, 2015. The decrease in fiscal 2016 reflected the $25.0 million milestone for FDA approval of ILUVIEN earned in the fiscal 2015 first quarter.

Research and development expense increased by $2.3 million, or 19%, to $14.4 million for fiscal 2016 compared to $12.1 million for fiscal 2015. The increase was primarily attributable to a $1.7 million increase in Medidur CRO and regulatory preparation costs and pre-clinical and other third-party research costs and $475,000 of personnel costs, including incentive compensation and contractual severance obligations.

General and administrative expense increased by $957,000, or 12%, to $9.0 million for fiscal year 2016 compared to $8.1 million for the prior year. The increase was primarily attributable to a $564,000 increase in personnel costs, including higher incentive compensation accruals and stock-based compensation, and a $303,000 increase in professional fees.

Income tax benefit was $155,000 for the year ended June 30, 2016 compared to income tax expense of $96,000 in fiscal 2015. Federal alternative minimum tax totaled $4,000 and $263,000 for fiscal 2016 and fiscal 2015, respectively, based upon U.S. taxable income for calendar year 2014, which was primarily due to the $25.0 million ILUVIEN FDA-approval milestone. Refundable foreign research and development tax credits totaled $159,000 in fiscal 2016 compared to $167,000 in fiscal 2015.

Today’s Conference Call Reminder.
pSivida Corp. will host a live webcast and conference call today, September 12, 2016, at 4:30pm ET. The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from international locations. The conference can also be accessed on the pSivida Corp. website at www.psivida.com. A replay of the call will be available approximately two hours following the end of the call through September 19, 2016. The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, Conference ID number 71781786.

About Posterior Segment Uveitis. Posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in developed and developing countries. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness and making it the third leading cause of blindness in the U.S.

Patients with posterior segment uveitis are typically treated with systemic steroids, but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects, including an increased risk of cancer. Medidur is designed to provide improved outcomes compared to standard of care, but with a significant reduction in side effects.

About Medidur Phase 3 Trials. pSivida is conducting two Phase 3 trials to assess the safety and efficacy of Medidur for the treatment of posterior segment uveitis. These are randomized, sham-controlled, double-masked trials. The primary endpoint of both trials is recurrence of posterior segment uveitis at six months, with patients in both trials followed for three years. The first Phase 3 Medidur trial enrolled 129 patients in 16 centers in the U.S. and 17 centers outside the U.S. The second trial will enroll up to 150 patients in approximately 15 centers in India.

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

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