Key Developments: OncoSec Medical Inc (ONCS.PK)
0.31USD
22 May 2013
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1,483,721
1,178,376
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Latest Key Developments (Source: Significant Developments)
OncoSec Medical Inc Promotes Veronica Vallejo As Chief Financial Officer
OncoSec Medical Inc announced that Vice President and Controller, Veronica Vallejo has been promoted to Chief Financial Officer effective February 8, 2013. Full Article
OncoSec Medical Inc Announces $7.2 Million Public Offering
OncoSec Medical Inc announced that it has entered into definitive agreements with institutional investors to purchase approximately $7.2 million of securities in a registered public offering. OncoSec has agreed to sell to institutional investors an aggregate of 28,800,000 shares of its common stock at $0.25 per share. Additionally, investors will receive warrants to purchase up to 14,400,000 shares of common stock at an exercise price of $0.26 per share for a term of four years. The gross proceeds of the offering are expected to be approximately $7.2 million . Net proceeds, after deducting the placement agent's fee and other estimated offering expenses payable by OncoSec, are expected to be approximately $6.5 million . OncoSec intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses. Full Article
OncoSec Medical Inc Reports Positive Preliminary Efficacy Results from phase II Study Of ImmunoPulse In Metastatic Melanoma Patients
OncoSec Medical Inc announced positive preliminary results from a Phase II trial investigating the use of ImmunoPulse in metastatic melanoma patients at the 6th World Meeting of Interdisciplinary Melanoma Skin Cancer Centres & 8th EADO Congress. This preliminary interim analysis of 13 out of 25 patients supports key findings from a Phase I trial suggesting that ImmunoPulse is able to induce regression or stabilization of distant untreated metastases following a single cycle of treatment. A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label and multi-center study. The trial was designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with ImmunoPulse. As per the protocol, a preliminary interim analysis was scheduled upon completion of 50% enrollment in the study. The purpose of the analysis was to confirm safety and efficacy observed in the Phase I study. At the time of this preliminary interim analysis, 13 patients were enrolled and treated. Thirteen subjects were evaluable at Day 39, nine at Day 90, and two at Day 180. 95% of treated lesions demonstrated response at Day 39 (5% progressive disease, 14% stable disease (SD), 42% partial response (PR), 39% complete response (CR)). All treated lesions at Day 90 (5% SD, 50% PR, 45% CR), and at Day 180 (33% PR, 67% CR) demonstrated a response. Full Article
OncoSec Medical Inc Reports Positive Interim Efficacy Results From Phase IV Study Of NeoPulse In Skin Cancer Patients
OncoSec Medical Inc announced positive interim results from a Phase IV trial investigating the use of NeoPulse in skin cancer patients. Data from the trial showed a complete response of greater than 90% in basal cell carcinoma patients and 70% in squamous cell carcinoma patients at six months. The primary goal of this phase IV cutaneous cancer study was to assess the ability of NeoPulse to control growth or recurrence of the cancer six months following treatment, equivalent to surgery as compared to historical controls, with respect to primary (new) tumors and locally recurrent tumors. The study was conducted at 15 clinical centers across Western Europe. A total of 88 patients were enrolled and received treatment. At the time of analysis, 69 of 88 (78.4%) patients were evaluable at the six-month follow-up. The complete response rate at six months among basal cell carcinomas was 92.8% and 70% among squamous cell carcinomas. Response rate of melanoma was not calculated since multiple tumors were treated with concomitant therapy. The treatment was well-tolerated. The most frequent treatment-related adverse events were pain, infection and insomnia; all were transient and manageable. Full Article
OncoSec Medical Inc Secures New Patent From China
OncoSec Medical Inc announced that it has received a new Method of Use and Device patent (Patent Application No. 200780014313.0, Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection) for the OncoSec Medical System (OMS) electroporation device platform from the State Intellectual Property Office of the People's Republic of China. Full Article
OncoSec Medical Inc OMS ElectroOncology For Head And Neck Cancer Shows Enhanced Quality Of Life In Two Randomized Phase III Studies
OncoSec Medical Inc announced data from an interim analysis of two randomized Phase III clinical trials, HNBE-01 and HNBE-02, using electrochemotherapy to treat locally recurrent and second primary squamous cell carcinoma of the head and neck (SCCHN). In these studies, electrochemotherapy was compared against surgery for quality of life, safety, survival and local control at eight months, where local control is defined as destruction of the treated tumor without evidence of reappearance of the tumor at the treatment site. The data show OMS ElectroChemotherapy achieved the primary endpoint of preserving quality of life compared to surgery, and appears to be safe and comparable to surgery in achieving control in locally recurrent or second primary SCCHN. This therapy represents a viable alternative to potentially major surgical interventions for this patient population, where recurrent tumors in SCCHN usually have a poor prognosis with a local control rate of 40-50% and frequently associated loss of organ function. OncoSec is evaluating the regulatory strategy alternatives for the most optimal path to market clearance based on the available Phase III and previously announced Phase IV data. Concurrently, the company is seeking partnering opportunities as it begins to approach the FDA and other regulatory bodies with product registration plans. Full Article
OncoSec Medical Inc Presents Preliminary Safety Data For Phase II Melanoma Study
OncoSec Medical Inc announced preliminary enrollment and safety data at the Second European Post-Chicago Melanoma Meeting in Munich, Germany for the Company's on-going Phase II metastatic melanoma clinical trial, OMS-I100. To date, OMS-I100, a Phase II open-label, multi-center clinical trial investigating the safety and efficacy of plasmid interleukin-12 (DNA IL-12) with electroporation, has completed approximately 50% of enrollment. Based on available safety data, no grade three or higher adverse events related to the treatment have been reported, and reported adverse events were treatable and transient. Full Article
OncoSec Medical Inc Announces Issuance Of New Patent For Method Of Use
OncoSec Medical Inc announced that the Commissioner of Patents, Commonwealth of Australia Patent Office recently granted a new Method of Use patent (Patent Application No. 2007224275, Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection) for the Company's OMS ElectroOncology treatment platform. The issuance of this patent has the potential to expand OncoSec's market opportunities for minimally invasive and surgical procedures to treat solid tumors, as an adjunct therapy to earlier-stage cancers. Specifically, it allows OMS technology to be used to treat the margins of solid tumors following surgical resection. Full Article
OncoSec Medical Inc Announces Manufacturing Agreement With VGXI Inc. For Production Of Interleukin-12 Plasmid DNA
OncoSec Medical Inc announced that it has entered into an exclusive cGMP manufacturing agreement with VGXI Inc. for the production of interleukin-12 plasmid DNA (DNA IL-12). Financial terms of the agreement were not disclosed. Full Article
OncoSec Medical Inc's ElectroChemotherapy Demonstrates Potential As Alternative To Surgery For Treating Head And Neck Cancer
OncoSec Medical Inc announced positive interim analysis of data from 81 subjects in a Phase IV study of primary and locally recurrent squamous cell carcinoma of the head and neck (HNSCC) treated with OMS ElectroChemotherapy in Europe. The study demonstrated the therapy's ability to provide local tumor control and quality of life outcomes that compare favorably to standard outcomes associated with surgery. The primary goal of this phase IV head and neck cancer study was to assess the ability of the OMS ElectroChemotherapy to control growth or recurrence of the cancer eight months following treatment, equivalent to surgery as compared to historical controls, with respect to primary (new) tumors and locally recurrent tumors. In this interim analysis, local tumor control was achieved in 46/49 (94%) primary tumors and 12/21 (57%) recurrent tumors. This meant that there was no recurrence of the tumors during the monitoring period. These were excellent results that were on par with the expected outcomes of surgery. Furthermore, evaluation of safety using the OMS ElectroChemotherapy for this patient population demonstrated that the treatment was safe and well-tolerated with no grade three or higher adverse events related to treatment reported during this study. In addition, the secondary endpoint of preservation of organ function and appearance using validated quality of life instruments demonstrated a positive outcome. Full Article
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