Generex Biotechnology Corp. (GNBT) spins out, stock points higher

Posted on: September 15th, 2011
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Generex Biotechnology Corp. (OTCBB: GNBT) saw its shares gain 8.7% to 9.89 cents, as Thursday’s markets closed, on news of the spinout of one of its subsidiaries. Volume for the stock was 1.3 million shares, nosing out its full-day average.

A news release dated Sept. 15 announced that the company, based in Worcester, Mass., provided an update on the status of the previously announced spinout of its wholly-owned subsidiary, Antigen Express, Inc.

The Company is in the midst of a detailed and comprehensive review of several transaction opportunities, including both shell companies and operating biotech companies with synergistic intellectual properties, in each case Securities and Exchange Commission registrants and Depository Trust Company eligible companies, into which Antigen Express will be merged.

Generex CEO Mark Fletcher, “We are undertaking our due diligence examination of available alternatives with a view to identifying an appropriate transaction for the Antigen Express spinout.

“We will proceed with expedition to negotiate an agreement with the target company, complete the merger of Antigen Express into that company, and conduct an initial fund raising. If the merger and the initial fund raising are successful, we will then seek a listing of the merged company’s stock on a national stock exchange.”

Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies.

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Bioheart Inc. (BHRT) has breakout day over FDA OK

Posted on: September 14th, 2011
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Bioheart Inc. (OTCBB: BHRT) leaped 15.3% to 8.3 cents Wednesday on word of a clinical program the company was engaging in, using adipose cells. Volume for the stock topped 8.1 million near Wednesday’s close.

A news release issued Sept. 14 declared that the company out of Sunrise, Florida announced that they will begin a U.S. clinical program called the ANGEL trial utilizing adipose derived cells or LipiCell for congestive heart failure patients. Using the clinical data from a Phase I/II trial in Mexico and preclinical studies, Bioheart will apply to the Food and Drug Administration (FDA) to begin a Phase I study in the US.

In collaboration with the Regenerative Medicine Institute of Tijuana, Mexico, six congestive heart failure patients have been successfully treated in a Phase I/II trial at Hospital Angeles Tijuana.

The therapy involves the use of stem cells derived from the patient’s own fat (adipose tissue) obtained using liposuction. These patients have demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their six-minute walk distance.

The U.S. ANGEL trial design and results from the Mexico trial were presented by Bioheart’s Chief Scientific Officer, Kristin Comella at the Stem Cells USA & Regenerative Medicine Congress in Boston this week. She was quoted in the same release as saying, “Safety and efficacy have been successfully demonstrated in the trial at Hospital Angeles and we are looking forward to beginning one of the first U.S. trials using adipose derived cells for congestive heart failure patients.”

Bioheart is committed to maintaining our leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.

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RXi Pharmaceuticals Corporation (RXII) clinical trials to continue, shares jump

Posted on: September 12th, 2011
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RXi Pharmaceuticals Corporation (Nasdaq: RXII) shares gained 12% to $1.12 Monday, after favorable news about the company’s breast cancer vaccine trial. Volume for the stock exceeded 3.5 million shares, compared to a daily average of 722,000.

A story published Monday in Boston Business Journal revealed that the U.S. Food and Drug administration has cleared the way for the start of Rxi to launch its Phase 3 trial studying a potential vaccine for a certain type of breast cancer.

If successful, the vaccine would provide an alternative for women who have low to intermediate expression of the HER2 mutation, and are not eligible for the blockbuster drug Herceptin, made by Swiss drug maker Roche AG.

The FDA has now lifted a partial clinical hold the agency put on the chemistry, manufacturing and controls associated with the vaccine trial.

Worcester, Mass.-based RXi acquired the potential vaccine, called NeuVax, when it bought Scottsdale, Ariz.-based Apthera. As part of the deal, Apthera’s shareholders initially received approximately 4.8 million shares of Worcester, Mass.-based RXi’s common stock, worth $7.2 million at the time, on March 30. The deal closed in April. Apthera’s stockholders will also be entitled to contingent payments tied to clinical, regulatory and commercial milestones connected to NeuVax.

The partial clinical hold was placed on the vaccine candidate before it was acquired by RXi, and its lifting will allow the company to start its Phase 3 trial in the first half of 2012. The study is expected to include about 100 trial sties in the U.S., Canada and Europe.

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Unigene Laboratories Inc. (UGNE) stock draws strength from property defence

Posted on: September 8th, 2011
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Unigene Laboratories Inc. (OTCBB: UGNE) charged ahead 8.9% to 98 cents Thursday, only a week or so after successfully defending its intellectual property portfolio. Volume for the stock surpassed 118,000 shares, far above its daily average around 39,000.

A news release dated August 30 revealed how on August 25, 2011 the United States Court of Appeals for the Federal Circuit declined to revive Apotex Inc.’s counterclaims and bid for summary judgment in Unigene Laboratories Inc.’s suit alleging the generic-drug maker infringed two patents for Fortical®.

The three-judge panel determined that a New York federal court correctly granted Unigene summary judgment that one of the claims of Unigene’s U.S. Patent Number RE40,812E was not obvious as well as rejected Apotex’s other attempts to invalidate the patent.

Company vice president Greg Mayes, was quoted thus in the August 25 release: “This is a very important decision for Unigene. Not only does this decision finally put the intellectual property litigation behind us and eliminate the prospect for further litigation costs and distraction, it clearly validates the ways in which we protect, prosecute, maintain and ultimately partner our robust IP portfolio.

Mayes continued, “Oral delivery partners can expect that our IP is fully enforceable and like the nasal spray patent, will survive the scrutiny of some of the highest courts in the land. This successful outcome sends a strong message of our confidence in and our commitment to defending the future paths our IP takes.”

Unigene, located in Boonton, New Jersey, is a leader in the design, delivery, manufacture and development of peptide-based therapeutics. The Company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence™ platform. Peptelligence encompasses extensive intellectual property covering delivery and manufacturing technologies, unsurpassed research and development expertise, and proprietary know-how representing a genuine distinctive competence.

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Advanced Cell Technology Inc. (ACTC) busy in Asia, though stock slid Thursday

Posted on: September 1st, 2011
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Advanced Cell Technology Inc. (OTCBB: ACTC) shares subsided 0.9% Thursday to 16.45 cents, on volume of 1.73 million shares.

A news release put out by The Bedford Report on August 24 noted that more North American stem cell research firms have found success forming International partnerships to help boost funding.

According to Bernard Siegel, director of the non-profit Genetics Policy Institute, U.S. stem cell firms are looking to Asia more for partnerships. Siegel is quoted in the Bedford Report as citing two reasons, one having to do with the attractiveness of Asian countries as markets for stem cell treatments, the other with Asia’s lower regulatory hurdles when compared to the U.S.

Based in Santa Monica, Calif., Advanced Cell Technology focuses on the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine.

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PLC Systems Inc. (PLCSF) favorable product news boosts stock

Posted on: August 18th, 2011
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PLC Systems Inc. (OTCBB: PLCSF) powered ahead 77.8% to 16 cents Thursday, on encouraging news for one of its renal medicines. Volume for the stock was 30,000 shares, more than five times its daily average.

A news release put out early August 18 announced that final results from the REMEDIAL II investigator-sponsored clinical trial of RenalGuard® in Italy have been published on-line in Circulation, a peer-reviewed journal of the American Heart Association with a distribution of 23,900 worldwide, and will appear in the September 2011 issue of the publication.  The results from this trial showed that RenalGuard is superior to the current standard of care at preventing Contrast-Induced Nephropathy (CIN) and in-hospital dialysis in high-risk patients undergoing certain imaging procedures.

Company CEO Mark Tauscher was quoted in the same release as saying, “The positive results of the REMEDIAL II clinical trial demonstrate with scientifically significant findings that RenalGuard is a superior approach to reducing the incidence of CIN in high-risk patients. This is another important proof point for RenalGuard and for PLC, and we’re delighted that these results have been favorably evaluated by Circulation’s advisory board and are now being shared with practitioners and potential partners from around the world.”

PLC Systems Inc., headquartered in Milford, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets.

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