Healthcare Industry News: Inovio Biomedical
News Release - June 19, 2007
Inovio Biomedical's Selective Electrochemical Tumor Ablation Therapy Shows Safety, Tolerability, and Significant Complete Responses in Breast Cancer StudyCompany Also Provides Update
SAN DIEGO--(HSMN NewsFeed)--Inovio Biomedical Corporation (AMEX:INO ), focused on the development of DNA vaccines for cancers and infectious diseases and a novel alternative to surgery to treat localized cancers, announced today that interim results from an FDA-approved Phase I/II study of 10 patients with recurrent breast cancer treated with Inovio's Selective Electrochemical Tumor Ablation (SECTA) therapy showed the therapy was safe, well-tolerated, and achieved a 75% complete tumor response rate.
The study results are being presented in a poster presentation titled, "A Safety and Efficacy Study of Bleomycin Sulfate and Electroporation in Patients with Metastatic or Locally Recurrent Breast Cancer," authored by Viktor Paramanov, MD, Oleh Tyurin, MD, Sergey Polenkov, MD, and Paul M Goldfarb, MD, FACS. This presentation will be at the VII Madrid Breast Cancer Conference, "Changes in the Treatment of Breast Cancer," June 20 - 22nd. The open-label, single-treatment trial in patients with recurrent breast cancer following partial or complete mastectomy used intratumoral administration of bleomycin followed by electroporation to significantly enhance uptake of the drug using Inovio's MedPulser® System. No treatment-related serious adverse events were observed. Non-serious adverse events were "unremarkable" during a 30-day follow-up period. Of 10 patients enrolled, two patients were not evaluable for tumor response: one patient was lost to follow-up and one patient is still ongoing. Six of eight (75%) evaluable patients and seven of nine (77.8%) evaluable tumors showed complete responses at 24 weeks or last evaluation.
"The result of this first organized study using SECTA to treat breast cancer has important clinical relevance and indicates the potential to use SECTA for an entirely new form of cancer," stated Dr. Paul Goldfarb, Consulting Medical Director to Inovio.
Dr. Avtar Dhillon, President and CEO, said, "These positive results reaffirm what had been previously indicated by a number of Inovio's other clinical studies: our SECTA therapy provided clinically beneficial outcomes for patients in those trials without serious adverse events and with nominal non-serious adverse events. We strongly believe in the clinical relevance of the SECTA therapy and believe these results will help prospective partners to better define the potentially broad applicability and market opportunity for this novel treatment."
Inovio's SECTA therapy uses bleomycin sulfate delivered intratumorally by the company's MedPulser® electroporation system. The purpose of this therapy is to provide treated patients with quality of life benefits compared to the use of surgery, with equivalency in terms of local tumor control and survival. Inovio is aiming to show these benefits with multiple clinical studies in several different cancer indications. The company has now completed enrollment of 13 patients in the FDA-approved Phase I/II clinical study of recurrent breast cancer patients. It has completed enrollment of 92 patients in a non-FDA, European pre-marketing study of head and neck cancer patients and expects to release interim results before the end of 2007. Inovio has enrolled 78 patients in a non-FDA, European pre-marketing study of patients with skin cancer. The protocol allows for up to 100 patients to be treated. For the benefit of concurrently analyzing data from multiple clinical studies and additional strategic reasons such as partnering, the company may decide to stop enrollment prior to enrolling 100 patients to expedite analysis of the data in this open label trial. Each cancer indication is the subject of a separate clinical development program owing to the unique and different clinical and biological attributes of each type of cancer the company is evaluating.
The company was enrolling patients in two Phase III clinical studies designed to evaluate the use of SECTA as a treatment for resectable recurrent and second primary squamous cell carcinomas of the head and neck (SCCHN). The studies were accruing North American and European patients with tumors in the anterior and posterior areas of the oral cavity. The primary endpoint of these two Phase III trials was preservation of function status at four and eight months as measured by the Performance Status Scale (which assesses the ability of a patient to eat "normal" foods, speak understandably, and eat in public). On June 5th, Inovio announced it stopped enrollment of these studies based on a recommendation from the trial's independent data monitoring committee (DMC). The DMC expressed concern about efficacy and serious adverse events, including higher mortality rates on the SECTA arm of the study than on the surgery arm. In the DMC's opinion, although no single parameter was sufficient to warrant recommending a review of the trial, the totality of data for this recurrent head and neck cancer study suggested an unfavorable benefit-to-risk profile for the SECTA arm relative to the surgery arm. The DMC also noted that slow enrollment presents a possible challenge in meeting the patient enrollment goals of each of these two trials, but that, if timely enrollment could allow reaching the target of 400 patients in the combined trials, this would provide enhanced insights regarding the benefit-to-risk profile of the SECTA treatment. Without conducting further analysis, Inovio stopped enrollment to allow the company to conduct its own interim analysis of the unaudited and unblinded data on the 212 patients enrolled to date. The company expects to complete this analysis before the end of the year.
Inovio's business plan for the SECTA therapy has been focused on generating a set of clinical data across multiple indications to aid in securing a marketing and sales partner and further characterize the therapy's clinical benefits, cost savings, and profit potential necessary to make this product viable and attractive to a partner to take it to the marketplace. Discussions with multiple partner candidates have been progressing and are continuing. Management's primary goal for SECTA is to secure an industry partner capable of launching the SECTA product, with the European market the initial priority. In an alternative approach, Inovio will consider an agreement with a financial partner. In this event, Inovio would contemplate creating an operating entity that would be funded and staffed independently of Inovio Biomedical. The objective would be to provide this entity with a mandate and certain resources to commercialize SECTA while retaining ownership in the entity but minimizing or eliminating ongoing capital obligations to Inovio. Management will work diligently to try to secure a suitable deal to advance commercialization of the SECTA therapy.
Three of Inovio's partners recently reported interim results from different clinical studies. All of these studies indicated that the combination of Inovio's delivery technology and DNA-based immunotherapeutics addressing different cancer types was safe and tolerable, and also provided evidence of heightened immune responses and/or tumor responses. These studies have provided initial proof of principle regarding the utility of Inovio's DNA delivery technology in humans, an important milestone for this technology and Inovio.
Inovio has license agreements in place with Merck, Wyeth and others. With a broad and growing pipeline of projects with different partners, indications, and DNA-based immunotherapies relating to cancers and chronic infectious diseases, Inovio is well-positioned to continue advancing with its partners through preclinical and clinical studies. With significant available cash resources, Inovio also intends to establish internal preclinical and clinical programs to develop DNA vaccines that may result in significant new intellectual property assets for the company. During the balance of 2007, Inovio is aiming to achieve multiple milestones for DNA-based immunotherapeutic applications in the form of new partnerships, initiation of new clinical studies, and other development initiatives.
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX: INO ) is focused on developing multiple DNA-based immunotherapies and commercializing its Selective Electrochemical Tumor Ablation (SECTA) therapy. Inovio is a leader in developing human applications of electroporation, which uses brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. For DNA vaccines, Inovio's technology has shown it can significantly increase levels of gene expression and immune responses. Inovio's immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, and the U.S. Army, with four DNA-based immunotherapies in Phase I clinical studies. The SECTA therapy is for locally ablating solid tumors. Inovio's technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans and that results in one clinical study may not reflect or project actual or likely results in other studies of the same or similar protocol), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2006, our 10-Q for the three months ending March 31, 2007, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
Source: Inovio Biomedical
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