CZ BioMed Corp. Announces Successful Reduction of Prostate Cancer Tumors More Than 50% Using PRO-RVLYSIS(R)
ACCESS Newswire
TAMPA, FL, August 26, 2013 -(ACCESSWIRE)- CZ BioMed Corp. announced today that it has received positive results for Atlanta, GA patient, Peter V., diagnosed with advanced prostate cancer with extracapsular disease associated with extensive pelvic lymphadenopathy and osseous metastatic disease. Studies of MRIs, before and after treatment, accurately demonstrate a greater than 50% reduction in tumor volumes.
Case report:
Peter V. is a 59 year old white male in otherwise healthy condition. The cancer itself is further classified as a Stage 4, hypointense T2 tumor engulfing the entire prostate. The tumor initially was invading the base of the bladder, seminal vesicles and distal sphincter with gross extracapsular extension into the left and right neurovascular bundles. Prior to treatment, a multiparametric MRI was performed by Partners Imaging Center of Sarasota, Florida using a Siemens 3.0 Tesla MRI on 04/01/2013. Soon after, the patient began 3 months of hormone therapy utilizing an LHRH analog ending 07/10/13. Simultaneously in April, Peter was selected for clinical trials overseas, and received 24 doses of CZ Biomed's novel oncolytic virotherapy, PRO-RVLYSIS(R) (twice a day for 12 days).The PRO-RVLYSIS(R) treatment was overseen by CZ Biomed's medical director Dr. Ronald Wheeler, M.D.It should be noted that PRO-RVLYSIS(R) was administered systemically, via I.V. only.
On 07/20/2013 a follow up scan, using the same model MRI, was performed at Emory University Hospital in Atlanta, GA. Partners Imaging Center's Dr. Richard Goldberg, M.D. analyzed and compared the imaging studies. The volume of the primary tumor had decreased by more than 50% since the prior exam from 8.0 x 6.7 x 6.6 cm^3 to 6.3 x 5.4 x 4.7 cm^3. In addition, there was a reduction in size of the bilateral lower pelvis lymphadenopathy. A large nodal mass within the right lower pelvis has decreased from 6.2 x 4.9 cm to 5.2 x 3.6 cm with less mass effect upon the right lateral urinary bladder. A nodal mass within the left lower pelvis has decreased from 5.2 x 4.1 cm to 3.7 x 2.5 cm. Multiple other lymph nodes have decreased as well. Furthermore, the multiple bony metastases were less apparent in the post treatment images and have faded in signal since the prior exam and the urinary bladder was no longer distended. There is no evidence for progressive or new disease. Finally, a PSA Test (prostate-specific antigens) was also performed before and after treatment. The initial PSA reading was 490 ng/mL and 3 months post-treatment PSA reading was only 67 ng/mL, a marked decrease.
These reductions are no doubt as a result of the two week systemic administration of PRO-RVLYSIS(R), as it is well known that the LHRH analog therapy alone only slows the growth of tumors and has not ever characteristically reduced or reversed tumor size. The results are exciting as Dr. Ronald Wheeler M.D. Medical Director, Dr. Lixian Jiang, Ph.D. Chief Operating Officer, Dr. John Zhang Ph.D. Chief Scientist and fellow CZ Biomed medical advisory board member Dr. Kenneth Forster, Ph.D. collaborate to finalize the protocol for submission to the US FDA for Phase 1 clinical trials.
PRO-RVLYSIS(R) is a genetically Engineered oncolyticvirus that selectively targets and destroys cancer cells, whilst leaving surrounding non-malignant cells unharmed/uninfected. The destruction of these cancer cells occurs either through direct lytic rupture via multiple cycles of viral replication or the subsequent induction of apoptosis, also known as programmed cell death. Thus, PRO-RVLYSIS(R) is vastly safer to use and easier for the body to process, as compared to traditional chemo or radio-therapies of tumors, allowing patients to enjoy a much higher quality of life during treatment. Human RSV is a respiratory tract-specific virus (similar to the "common cold" virus) that primarily infects children (under 1 year of age), but it does not cause disease in young and older adults. This trait alone may prove CZ BioMed's RSV-based treatments to be much more palatable and accepted by patients, as well as the medical community, compared with some much more dangerous viruses currently being investigated for their oncolytic properties.
"We are very pleased to receive these results today. Our hard work and dedication to cure cancer has brought us another step closer. This breakthrough confirms our patients can recover faster, with a higher quality of life during treatment. This is only the beginning. We have many more positive results coming for other cancers as well..." ~ Calvin Cao, Chairman/CEO/President of CZ BioMed Corp.
As a result of this milestone, CZ BioMed Corp. will now open aggressive discussions with all interested global bio-pharmaceutical leaders regarding partnership and licensing arrangements. Simultaneously, the company will begin IND (Investigational-New-Drug) filings with the United States FDA to initiate Phase 1 clinical trials.
CZ BioMed Corp. is a privately held Biotechnology company based in Tampa, FL, focused on the discovery, development and commercialization of a new class of high-tech biological products for the treatment of a wide variety of human cancers. CZ BioMed products use novel oncolytic viruses that have been genetically engineered to selectively target tumor cells, but not normal healthy cells. The mission of CZ BioMed Corp. is rooted in the knowledge of our invention with the products we provide positively affecting the quality of patients lives. Since everything we do, no matter how small, impacts the end product and ultimately people's lives, we accept only the highest ethical and quality standards, both from ourselves and others.
For further information about CZ BioMed Corp. please visit: www.czbiomed.com
Forward Looking Statements
This report includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. The information in this news release includes certain forward-looking statements that are based upon assumptions that in the future may prove not to have been accurate and are subject to significant risks and uncertainties. Although the company believes that the expectations reflected in its forward-looking statements are reasonable, it can give no assurance that such expectations or any of its forward-looking statements will prove to be correct. Factors that could cause results to differ include, but are not limited to, successful performance of internal plans, product development acceptance, and the impact of competitive services and general economic risks and uncertainties.
