|GeoVax surges higher on HIV study results. Teva MS pill achieves Phase III goals. Access Pharma obtains MuGard insurance coverage|
|By BioMedReports.com Staff|
|Thursday, 09 December 2010 20:05|
Shares of GeoVax Labs, Inc. (OTCQB/OTC Bulletin Board: GOVX) gained more than 72% after the company announced that early results from part A of an ongoing phase 2a clinical trial indicate an excellent safety profile and highly reproducible immunogenicity. The phase 2a trial is testing two recombinant DNA-vectored vaccine inoculations; the first at week 0 and the second at week 8, followed by two recombinant MVA-vectored vaccine inoculations, at weeks 16 and 24. The still-blinded data for 180 trial participants, enrolled at a ratio of two vaccine recipients for each placebo, reveal no safety concerns. These results are very similar to those observed in the Phase 1 trial. The trial, designated HVTN 205, is being conducted by the HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health.
Of particular interest are assay results measuring vaccine-induced cellular (T-cell) immune responses, which are available for 128 of the participants. These tests revealed cellular immune response rates similar to those observed in the Phase 1 trial. Additional testing is ongoing to measure antibody responses and to further characterize cellular immune responses. Data will continue to be accumulated as the trial is completed.
Shares of GEOVAX soared 65 cents to $1.55.
Shares of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) moved higher on heavy volume today after the worlds largest generic drugmaker and its partner, Active Biotech (NASDAQ OMX NORDIC: ACTI), announced initial results from the two-year Phase III ALLEGRO study, which demonstrated that relapsing-remitting multiple sclerosis (MS) patients treated with 0.6 mg daily oral laquinimod experienced a statistically significant reduction in annualized relapse rate compared to placebo. Additional clinical endpoints, including significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS), were also achieved.
The study also found that Laquinimod was safe and well-tolerated, adverse events were comparable to those observed in the placebo group, no deaths were reported and incidence of infections was similar between the two arms of the trial.
"This pivotal study met its primary endpoint while maintaining a very good safety profile," says Principal Investigator, Professor Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the University Vite Salute, San Raffaele, Italy. "Laquinimod demonstrated a significant reduction in the progression of disability which may be explained by its unique mechanism of action that includes neuroprotective properties. Laquinimod may therefore be a promising therapeutic option for the MS community."
"We are very pleased to have achieved this major milestone in the development of oral laquinimod, a novel therapy that can potentially improve the lives of many MS patients in a safe way," said Shlomo Yanai, Teva's President and Chief Executive Officer.
The company expects to report details of the study in early 2011. Teva currently markets a branded injectable MS drug known as Copaxone.
More than 20 million shares changed hands as shares of Teva surged $3.36 to $52.63.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob), announced Thursday that it has made significant progress in obtaining MuGard reimbursements from various insurance plans such as Blue Cross Blue Shield, Health Net, Caremark, Well Point Next Rx, Harvard Pilgrim and Medicaid.
"Receiving these reimbursements affirms that national payers understand the critical role MuGard plays in the management of oral mucositis and serves as strong validation of the clinical and pharmacoeconomic viability MuGard offers," said Jeff Davis, President and CEO, Access Pharmaceuticals. He continued, "Our effort to land additional reimbursements is ongoing as it provides an incentive for clinics and hospitals to more quickly integrate the MuGard into their treatment protocols for cancer patients."
On Wednesday, as reported here on BioMedReports, Access Pharma announced that it had enetered into an agreement with "a major global pharmaceutical company" to test their oral insulin formulation based upon its proprietary vitamin B-12-based Drug Delivery Technology known as CobOral.
Shares of Access Pharma jumped 44 cents or 15.44% to $3.29.
Applied DNA Sciences, Inc. (OTC.BB:APDN), a provider of DNA-based security solutions, and Nissha Printing Co. Ltd. announced their collaboration to market DNA-based security printing on in-mold-decoration products. APDN sells its patented botanical DNA markers, trademarked SigNature®, to protect brands, ensure the security of cash and valuables in transit and for military and police security.
APDN sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied, and provide a forensic chain of evidence that can be used to prosecute perpetrators
Genomic Health, Inc. (Nasdaq:GHDX) today announced the first results of a large prostate cancer study that identified 295 genes strongly associated with clinical recurrence following radical prostatectomy. Top-line findings from this study, which applied the same RT-PCR technology used in Genomic Health's Oncotype DX® breast and colon cancer tests, will be presented today at the Society for Urologic Oncology (SUO) annual meeting. The Company and its research partners from Cleveland Clinic plan to present complete data at the ASCO Genitourinary Cancer Symposium in February 2011.
"We have reached an important milestone in our clinical development of a test for prostate cancer by narrowing down specific genes and pathways that predict prostate cancer aggressiveness," said Steven Shak, chief medical officer at Genomic Health. "Developing a test that can address a critical dilemma in today's standard of care will require well-designed clinical studies with reproducible evidence and the ability to work with very small amounts of biopsy tissue. These study results give us confidence to move forward with full clinical development, and we are evaluating the opportunity to accelerate these efforts with our scientific advisors."
Neoprobe Corporation (OTCBB:NEOP.ob), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has requested and been granted a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding its RIGS technology Biologic License Application (BLA). The pre-IND meeting request is another step in Neoprobe’s efforts to develop and commercialize the RIGS technology designed to enhance the surgical treatment of patients with solid tumor cancers.
"The pre-IND meeting request is one of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology program," said Rodger Brown, Neoprobe’s Vice President of Regulatory Affairs and Quality Assurance.
PharmAthene, Inc. (NYSE Amex: PIP) announced today that the United States Food and Drug Administration (FDA) has provided formal consent for PharmAthene to reinitiate clinical testing of its anthrax anti-toxin, Valortim®, after lifting the partial clinical hold placed on the program in late 2009.
"We're very pleased to resume clinical testing of Valortim®," remarked Dr. Thomas Fuerst, Senior Vice President and Chief Scientific Officer. "The accumulating data suggest that Valortim® may have unique characteristics, which could position it as a leading candidate for future procurement in the nation's biodefense stockpile. A presumed different mechanism of action, relative to other anthrax monoclonal antibodies and encouraging efficacy data in animal studies at low doses, suggest that Valortim® may offer important advantages in the treatment of symptomatic anthrax infection. We have proposed moving forward with a Phase I intravenous dose-escalation study of Valortim®, which is expected to commence in the next several weeks. We look forward to resuming clinical testing of this important anthrax anti-toxin candidate, which we hope one day will offer improved protection for our nation's citizens, both at home and on the battlefield."
As reported earlier today here on BioMedReports, several key announcements have pushed Advanced Cell Technology's (OTCBB: ACTC) stock from just under a nickel in late November to an intraday high of $.20 during Wednesday's session and volume has made it apparent that a growing crowd of day traders momentum players have now joined biotech investors in cheering on the small biotech.