On May 16, 2016 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter ended March 31, 2016 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA-based immunotherapy (Press release, Celsion, MAY 16, 2016, View Source [SID:1234512425]).

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"We are extremely pleased with our product portfolio, our progress and the investment we have made in gene-based therapeutics," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "Over this past quarter alone, we have reported meaningful developments with both ThermoDox and our immunotherapeutic, GEN-1. Positive clinical, preclinical and translational data for GEN-1 in both first line and second line ovarian cancer has provided important insights on its potential clinical utility and safety, and reinforced our confidence in the potential of this important investigational product. We are looking forward to continued meaningful data from our Phase I neoadjuvant trial, the OVATION Study, throughout the year and its support for launching the Phase I/II clinical study later this year to evaluate the combination of GEN-1 with Avastin and Doxil in platinum-resistant ovarian cancer patients."

Mr. Tardugno continued, "We have made great strides to advance our global Phase III OPTIMA Study evaluating ThermoDox in primary liver cancer with clinical sites currently enrolling patients in 13 countries world-wide. With enrollment now open in China and approximately 50% of the 850,000 new cases of primary liver cancer diagnosed each year originating there, China represents a significant market opportunity and key element of our global development and commercialization strategy for ThermoDox. We expect to add up to 20 additional clinical sites and enroll more than 200 patients in the China territory, the minimum number required by the China FDA to file a New Drug Application (NDA), assuming positive clinical results."

Recent Developments

ThermoDox

Enrolled the first patient in the OPTIMA Study in China. On April 26, 2016, the Company announced that the first patient in China has been enrolled in its ongoing global Phase III OPTIMA Study. With China FDA’s approval of Celsion’s Phase III Study in first line primary liver cancer, the trial is now enrolling patients in 13 countries globally. With the addition of these Chinese clinical sites, the Company expects an increase in the rate of recruitment sufficient to complete enrollment in the OPTIMA Study by the end of 2017 or early 2018. Results from the OPTIMA Study, if successful, will provide the basis for a global registration filing and marketing approval.

GEN-1 Immunotherapy

Announced positive data from the first cohort of patients in the Phase 1b OVATION Study. In May 2016, the Company announced data from the first cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first three patients dosed, GEN-1 plus standard chemotherapy produced positive clinical results, with no dose limiting toxicities and promising efficacy signals leading to successful surgical outcomes.

Of the three patients treated in the first cohort, two patients demonstrated stable disease (SD) and one patient demonstrated a complete response (CR), as measured by RECIST criteria.
All patients had successful resections of their tumors, with two patients having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and one patient with Stage IV ovarian cancer having an optimal R1 resection.
One patient demonstrated a pathological complete response (pCR). pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection, and have been associated with a median overall survival (OS) of 72 months, which is more than three years longer than those who do not experience a pCR.
All patients experienced a dramatic > 96% drop in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells. A 50% reduction in CA-125 levels is considered meaningful. All patients’ CA-125 levels were below the standard cutoff level of 35 U/mL.
Presented preclinical data for GEN-1 IL-12 Immunotherapy in combination with Avastin and Doxil at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016. In April 2016, the Company presented compelling preclinical data demonstrating significant synergistic anti-cancer effects when GEN-1 is combined with Avastin and Doxil, a current standard of care (SoC) for platinum resistant ovarian cancer patients at the 2016 AACR (Free AACR Whitepaper) Annual Meeting. The presentation showed that the three drug combination resulted in a statistically significant reduction of tumor burden of greater than 98% compared to control, and a statistically significant 92% reduction in tumor burden compared to Avastin plus Doxil alone. In contrast, Avastin and GEN-1 produced a 39% and 50% reduction in tumor burden, respectively. These preclinical data are consistent with the mechanism of action for GEN-1, which exhibits certain anti-angiogenic properties in addition to its well-characterized immunomodulatory activities. The combination of GEN-1 with Avastin and Doxil was well-tolerated with no systemic toxicities. These preclinical data will be used by the Company to support a comprehensive IND protocol filing for a Phase I/II clinical trial evaluating the combination in recurrent ovarian cancer later this year.

Reported translational data from its Phase Ib Study of GEN-1 Immunotherapy in recurrent ovarian cancer. In January 2016, the Company announced new translational data from its Phase Ib study of GEN-1 in patients with platinum-resistant ovarian cancer. The new data indicated that intraperitoneally-administered GEN-1 produces an immunologically distinct IL-12 protein that is localized at the tumor site and lasts for up to one week after a single treatment. In addition, concomitant increases in IFN-γ and TNF-α indicate that the IL-12 produced following treatment with GEN-1 treatment is immunologically active. Celsion intends to collect additional translational data, including cellular responses in primary tumor tissue and peritoneal ascites, in its ongoing OVATION Study, a Phase I dose escalation study in newly diagnosed ovarian cancer patients in the neoadjuvant setting.

Financial Results

For the quarter ended March 31, 2016, Celsion reported a net loss of $5.7 million, or $0.24 per share, compared to a net loss of $7.0 million, or $0.35 per share, in the same period of 2015. Operating expenses were $5.3 million for the quarter ended March 31, 2016 compared to $6.5 million in in the same period of 2015. This decrease was primarily due to lower research and development and general and administrative expenses in the first quarter of 2016 compared to the first quarter of 2015.

Research and development costs were $3.4 million in the first quarter of 2016 compared to $4.5 million in the same period of the prior year. In the first quarter of 2015, the Company produced clinical supplies to support both its ThermoDox and GEN-1 clinical programs. General and administrative expenses were $1.9 million in the first quarter of 2016 compared to $2.0 million in the same period of the prior year.

Net cash used in operations was $4.7 million the first quarter of 2016 compared to $5.9 million in the same period of the prior year. The Company ended the first quarter of 2016 with $14.3 million of total cash and cash equivalents.

On May 11, 2016 Lytix Biopharma reported LTX-315’s ability to enhance infiltration of CD8 positive T-cells in murine and human tumors, and T-cell clonality in B16 melanomas (Press release, Lytix Biopharma, MAY 14, 2016, View Source [SID:1234514842]). These abilities make LTX-315 an ideal partner for beeing combined with other types of immunotherapy. The strong synergy between LTX-315 and anti-CTLA-4 in preclinical cancer model was also presented.

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On May 13, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that an article has been published detailing the immuno-ablative mechanism of action of PV-10, the Company’s novel investigational drug for cancer (Filing, 8-K, Provectus Pharmaceuticals, MAY 13, 2016, View Source [SID:1234512346]).

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The article, titled, "Intralesional Rose Bengal in Melanoma Elicits Tumor Immunity Via Activation of Dendritic Cells by the Release of High Mobility Group Box 1," appears as an advance publication in Oncotarget, an Open-Access journal, and can be accessed by visiting:
View Source

The article documents results of a multi-year, multidisciplinary translational medicine program led jointly by Shari Pilon-Thomas and Amod A. Sarnaik of Moffitt Cancer Center in Tampa, Florida. The authors report detailed data on the mode in which intralesional injection of PV-10 (rose bengal) selectively kills tumor cells and the immunologic signaling that results from tumor ablation, starting with release of High Mobility Group Box 1 (HMGB1, a Damage-Associated Molecular Pattern molecule released by dying cancer cells that can serve as an immunological adjuvant to promote phagocytosis, antigen-presentation, and dendritic cell activation). The authors then follow this signaling through antigen uptake and dendritic cell activation, T cell priming and activation in peripheral blood, and culminating in a tumor-specific immune response marked by T cell infiltration and regression of uninjected tumors.

Eric Wachter, CTO of Provectus, observed, "The Moffitt researchers have systematically documented each of the key steps in the immuno-oncology cycle described by Chen and Mellman in their landmark review article (Oncology Meets Immunology: the Cancer-Immunity Cycle. Immunity 2013; 39: 1-10). In an exemplary demonstration of translational medicine, this team identified important immunologic markers in model systems and verified key facets of these in clinical trial participants, and similarly identified other markers in clinical trial participants and substantiated these in mouse models. While a number of their main observations were previously reported at scientific meetings, these are presented here in detailed, integrated fashion for the first time."

Shari Pilon-Thomas of Moffitt, stated, "Concordance of tumor-specific T cells in peripheral blood of clinical trial participants and mice led us to look for triggers of T cell activation. Working back from these observations, we found that HMGB1 release was common in mouse and man after tumor ablation with PV-10. These results support PV-10 ablation and the resulting tumor necrosis as the upstream trigger for systemic anti-tumor response."

Wachter noted, "This paper is a watershed event in the development of PV-10, walking the reader through all the steps of immune activation after PV-10 injection, from immunogenic cell death and signaling via release of HMGB1, dendritic cell recruitment and infiltration into draining lymph nodes, activation of tumor-specific T cells, and killing of uninjected tumors upon infiltration by these T cells."

Wachter added, "This mechanism of action informed the design of the two active PV-10 clinical trials: NCT02288897 in patients with locally advanced cutaneous melanoma (melanoma limited to the skin) to test the hypothesis that PV-10 alone can produce a systemic immune response that translates to longer progression free survival (PFS); and NCT02557321 in patients with later stage melanoma to test whether combination of PV-10 with the recently approved systemic immunotherapy, pembrolizumab, can "induce and boost" an immune response against melanoma."

On May 13, 2016 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the quarter ending March 31, 2016, the third quarter of the 2016 fiscal year (Press release, DelMar Pharmaceuticals, MAY 13, 2016, View Source [SID:1234512360]). The Company also highlighted recent corporate and clinical achievements and provided an overview of expected near-term milestones.

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DelMar management will host a business update conference call and live webcast for investors, analysts and other interested parties on Thursday May 19, 2016 at 5 pm EDT.

RECENT CORPORATE HIGHLIGHTS

Raised $6.1 million in new capital through private placement of preferred shares and restructured certain investor warrants in order to help position the Company to qualify to list its common stock on a senior exchange;
Confirmed that the Company plans to meet with the US Food and Drug Administration (FDA) to discuss a Phase III study design for refractory glioblastoma multiforme (GBM) during the first half of 2016;
Presented new data demonstrating that VAL-083 appears to have a distinct mode of action from other chemotherapies widely used in the treatment of cancer;
Entered into a collaboration agreement with the University of Texas MD Anderson Cancer Center (MD Anderson) to accelerate the clinical development of VAL-083 for the treatment of GBM. As part of the collaboration, MD Anderson will initiate a new Phase II clinical study with VAL-083 in patients with GBM at first recurrence/progression, prior to Avastin exposure;
Obtained an orphan drug designation for VAL-083 in the United States for the treatment of ovarian cancer and medulloblastoma, in addition to previous orphan drug designations for VAL-083 in glioma in the USA and Europe; and
Presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting that confirmed a well-tolerated VAL-083 dosing regimen of 40 mg/m2/daily every 3 days in a 21-day cycle has been selected for advancement into a Phase III study as a potential new therapy for the treatment of refractory GBM.
"Our data continues to demonstrate VAL-083’s unique cytotoxic anti-cancer mechanism which may provide new treatment opportunities for patients whose cancer has failed or is unlikely to respond to currently available therapies. In particular, the data we have presented in our refractory GBM clinical trial positions us to advance this program into registration-directed Phase III clinical trials and we look forward to discussing our proposed trial design with the FDA," said Jeffrey Bacha, DelMar’s chairman & CEO.

"Importantly, new funds raised subsequent to quarter end enable us to fund current operations through 2017 and help position DelMar to qualify to list its common stock on a senior exchange."

EXPECTED NEAR-TERM MILESTONES

Apply to list our shares on a senior stock exchange;
Engage the FDA regarding the design of a proposed registration-directed Phase II/III clinical trial for VAL-083 in refractory GBM;
Initiate the Phase II clinical study at MD Anderson with VAL-083 in patients with GBM at first recurrence/progression;
Initiate clinical studies in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;
Initiate new clinical trials with VAL-083 in refractory non-small cell lung cancer;
Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;
Continue to pursue pre-clinical research with leading investigators to advance VAL-083 as a potential treatment for other chemo-resistant cancers including ovarian cancer and pediatric medulloblastoma;
Maximize the value of the VAL-083 pipeline through potential partnering opportunities in high value oncology markets;
Continue to build the Company’s intellectual property portfolio; and
Continue to implement strategies to enable DelMar to meet qualifications to list its shares on a senior stock exchange.
CONFERENCE CALL DETAILS

DelMar plans to host a conference call on Thursday, May 19, 2016, at 5 p.m. EDT, to discuss quarterly results and provide a corporate update. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 800‑895‑1549 (toll free) with Conference ID DELMAR. A link to the webcast and slides will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE THIRD QUARTER OF FISCAL YEAR 2016 ENDED MARCH 31, 2016

For the three months ended March 31, 2016 the Company reported a net loss of $1,140,401, or a net loss per share of $0.03, compared to a net loss of $2,086,719, or a net loss per share of $0.05 for the three months ended March 31, 2015, as restated.

For the nine months ended March 31, 2016 the Company reported a net loss of $5,408,479, or a net loss per share of $0.12, compared to a net loss of $4,223,087, or a net loss per share of $0.11 for the nine months ended March 31, 2015, as restated.

FINANCIAL SUMMARY

The following represents selected financial information as of March 31, 2016. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and Management’s Discussion and Analysis ("MD&A"), as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

Selected Balance Sheet Data

March 31,
2016
$

June 30,
2015
$

(as restated)

Cash and cash equivalents

937,355

1,754,433

Working capital

439,470

1,722,336

Total assets

1,155,311

2,575,421

Derivative liability

1,017,250

2,364,381

Total stockholders’ deficit

(687,603)

(821,490)

Selected Statement of Operations Data
For the Three Months Ended:

March 31,

March 31,

2016

2015

$

$

(as restated)

Research and development

790,323

641,839

General and administrative

630,226

500,753

Change in fair value of derivative liability

(276,584)

781,152

Change in fair value of derivative liability due to change in warrant terms

7,000

–

Loss on exchange of warrants

–

156,219

Foreign exchange (gain) loss

(10,523)

6,826

Interest income

(41)

(70)

Net loss from operations

1,140,401

2,086,719

Basic weighted average number of shares outstanding

44,309,098

38,976,827

Basic loss per share

0.03

0.05

For the Nine Months Ended:

March 31,

March 31,

2016

2015

$

$

(as restated)

Research and development

2,183,355

1,925,635

General and administrative

1,994,923

1,601,982

Change in fair value of derivative liability

943,050

451,794

Change in fair value of derivative liability due to change in warrant terms

270,965

(23,658)

Loss on exchange of warrants

–

249,062

Foreign exchange loss

16,257

16,512

Interest expense

–

2,091

Interest income

(71)

(331)

Net loss from operations

5,408,479

4,223,087

Basic weighted average number of shares outstanding

43,587,549

37,732,995

Basic loss per share

0.12

0.11

About VAL-083

VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar (temozolomide).

DelMar recently announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. Patients have been enrolled at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Patients in a low dose (≤5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

Further details can be found at View Source

On May 13, 2016 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported financial results for the three months ended March 31, 2016 (Press release, CASI Pharmaceuticals, MAY 13, 2016, View Source [SID:1234512363]).

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The Company reported a net loss for the first quarter of 2016 of ($1.8 million), or ($0.04) per share, compared with a net loss of ($1.8 million), or ($0.06) per share, for the same period last year. As of March 31, 2016, CASI had cash and cash equivalents of $13.9 million.

Sara B. Capitelli, Vice President, Finance and Principal Accounting Officer, commented, "Our research and development expenses for the first quarter increased over the prior year due to start-up costs and patient enrollment costs associated with our FLC trial in the U.S. Our general and administrative expenses for the first quarter decreased over the prior year due to cost savings associated with business development and investor relations activities. As we continue to execute our clinical development plans in the U.S., Canada and China, we expect operating expenses to increase in 2016."

Dr. Ken Ren, Chief Executive Officer, commented, "We are pleased with our first quarter financial results, which are indicative of the operational efficiencies we have achieved. Our fundamentals remain strong and we believe the outlook for CASI is excellent. In 2016, we look forward to further advancement of ENMD-2076 and our other internal programs, and further progress in our in-licensed programs from Spectrum Pharmaceuticals. With the recent expansion of our business development team, we expect to accelerate our licensing activities and secure further partnerships to expand our pipeline as we move forward to becoming a fully-integrated world-class pharmaceutical company."