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Provectus Biopharmaceuticals Submits PV-10 Phase 3 Melanoma Protocol to FDA

On November 6, 2014 Provectus Biopharmaceuticals reported that it has submitted its phase 3 protocol for evaluation of PV-10 for treatment of locally advanced cutaneous melanoma to the FDA (Press release Provectus Pharmaceuticals, NOV 6, 2014, http://www.pvct.com/pressrelease.html?article=20141106.3 [SID:1234500938]). The FDA is expected to review the submission and comment on the proposed study population, clinical endpoints, and statistical analyses within 30 to 45 days. Provectus believes details of the protocol will be available publicly on www.clinicaltrials.gov within the next few days.

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The submission of the protocol follows completion of the due diligence audit of Provectus’ regulatory documents for PV-10 and PH-10. The purpose of the audit was to ensure that all the regulatory documents were in order.

Provectus anticipates few, if any, significant issues to arise from review of the protocol based on the substantive contact it has had with the FDA since the Company had its Type C meeting with the Agency on December 16, 2013. In particular in its letter of May 16, 2014 to the Company, the FDA gave guidance on assessment methods and endpoints that Provectus has incorporated into its phase 3 submission.

Shareholders received a letter from the CEO dated July 8, 2014 that detailed these interactions with the FDA. The letter read in part, "The primary endpoint of the study is progression-free survival (PFS) assessed using standard RECIST 1.1 criteria. Secondary endpoints are complete response rate and overall survival. Progression-free survival and overall survival are standard endpoints for oncology approvals. With these assessment methods and endpoints we’re following what the FDA has suggested to document the clinical benefit to patients after intralesional injection. And, we’ll measure patient reported outcomes to better characterize the relationship between complete response and symptoms of locally advanced cutaneous melanoma, such as pain and bleeding."

Pipeline

B-701 is a human IgG1 monoclonal antibody that is highly specific for FGFR3 which is under development by BioClin Therapeutics for the treatment of cancer (Company Pipeline BioClin Therapeutics, NOV 6, 2014, View Source [SID:1234500934]).

CYP 0150

CYP0150 is a recombinant protein consisting of a human IL-15 linked to the Sushi+ domain of the human alpha chain receptor (transpresentation) which is under development by Cytune Pharma for the treatment of cancer (Company Pipeline Cytune Pharma, NOV 6, 2014, View Source [SID:1234500931]).

Genmab Announces Additional Data from Phase III Study of Ofatumumab as Maintenance Therapy for Relapsed CLL

On November 6, 2014 Genmab reported additional data from the interim analysis of the ofatumumab (Arzerra) Phase III study, PROLONG (OMB112517) (Press release Genmab, NOV 6, 2014, View Source [SID:1234500929]). The study evaluated ofatumumab maintenance therapy versus no further treatment (observation) in patients with a complete response (CR) or partial response (PR) after 2nd or 3rd line treatment for chronic lymphocytic leukemia (CLL). The improvement in the study’s primary endpoint, progression free survival (PFS), met the prespecified statistical significance level for the interim analysis.

A total of 474 patients were included in the interim analysis. Patients who received ofatumumab maintenance treatment lived 13.4 months longer without their disease worsening (median PFS) than patients who received no further treatment. Median PFS was 28.6 months for the ofatumumab treatment arm and 15.2 months for the observation arm (Hazard Ratio 0.48; p<0.0001).

The amount of time until patients started their next therapy was significantly longer in the ofatumumab treatment arm than in the observation arm (median 38.0 months vs 27.4 months, Hazard Ratio 0.63; p=0.0076).

There were no unexpected safety findings. Adverse events occurred in 87% of patients in the ofatumumab treatment arm versus 75% in the observation treatment arm. In the ofatumumab treatment arm, 25% of patients experienced grade 3-4 adverse events compared to 17% in the observation arm. Grade 3-4 infections were 18% in the ofatumumab arm and 13% in the observation arm. The two most common grade 3-4 adverse events were neutropenia (22% in ofatumumab arm vs 9% in observation arm), and pneumonia (7% in ofatumumab arm vs 4% in observation arm). The death rate was similar in both arms (14%).

"The interim results of this study show that ofatumumab maintenance therapy significantly extended the amount of time the patients in the study lived without their CLL symptoms getting worse," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

These data will be presented in an oral session at the 56th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Francisco, California on December 6 from 12 Noon to 1:30PM PST.

MorphoSys’s MOR208 Program Receives Fast Track Designation from FDA for the Treatment of DLBCL

On November 7, 2014 MorphoSys reported that the Food & Drug Administration (FDA) has granted fast track designation to MOR208, MorphoSys’s humanized Fc engineered monoclonal antibody against CD19, for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release MorphoSys, NOV 7, 2014, View Source [SID:1234500937]). The FDA’s fast track program aims to expedite the development and review of drugs that have the potential to fill an unmet medical need in serious or life-threatening conditions.

“First results of our ongoing Phase 2 trial, which we will present at this year’s ASH (Free ASH Whitepaper) conference in December, have helped to identify diffuse large B-cell lymphoma as a valuable development opportunity for MOR208. We are therefore delighted to have received the fast track designation for further development of MOR208 in DLBCL. The more frequent interactions with the FDA that this enables will help us to expedite the development of MOR208 in this particular subset of non-Hodgkin’s lymphoma patients,” commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

DLBCL is the most common lymphoma and accounts for approximately 25 percent of all NHLs in the developed world. The disease occurs primarily in older individuals, though it can also occur in children and young adults in rare cases.

MOR208 is a humanized monoclonal antibody targeting the antigen CD19, which is being developed for the treatment of B-cell malignancies. The program is currently in phase 2 clinical development in chronic lymphocytic leukemia (CLL), acute lymphoblastic B-cell leukemia (B-ALL) and non-Hodgkin’s lymphoma (NHL). MOR208 was in-licensed from Xencor Inc. in 2010.