CEL-SCI Corporation (AMEX: CVM) Buzz Stock of the Day

Posted on Monday, September 21st, 2009

Shares of CEL-SCI Corporation (AMEX: CVM) jumped more than 24 percent in morning trading Monday after the company announced plans to move forward with two highly-anticipated drug trials.

In addition to recent FDA approval to go ahead with clinical trials of CEL-SCI’s novel LEAPS-H1N1 flu medication, the company has also raised the capital necessary to go forward with Phase III clinical trials of its flagship cancer treatment, Multikine, which analysts believe could become a standard of care for cancer treatment.

The company announced last week that a definitive agreement had been reached to raise nearly $20 million, which was expected to close on or before Monday.

The agreement states that CEL-SCI will sell 14,285,715 shares of common stock at a price of $1.40 per share for a gross profit of approximately $19 million. Additionally, investors will also receive warrants to purchase 4.7 million shares of CEL-SCI’s common stock at $1.50 per share that can be exercised any time after the transaction closing within a two-year time period.

CEL-SCI will use the funds to move forward with human clinical trials for LEAPS-H1N1 flu treatment, a drug designed to treat the white-blood cells of already-infected patients. The FDA’s approval of trials for CEL-SCI’s H1N1 flu treatment has pushed CEL-SCI shares to some of the most heavily traded in the biotech market.

“Everybody’s focus is on vaccines and they’re having all kinds of problems with the vaccines, but there has to be someone working to help these patients who have a high likelihood of death,” said CEL-SCI’s CEO Geert Kersten. “That’s how we got to that. With LEAPS, we can control in advance and determine, almost by design, how the immune system will process the epitope and therefore we know what kind of immune response we will get — whether cellular or humoral. By doing that, you can — we feel — have significant impact on these people’s chances of survival.”

CEL-SCI is also expected to start long-awaited and highly-anticipated Phase III trials of Multikine, the company’s advanced head and neck cancer treatment. The first of its kind, Multikine is a multi-targeted approach cancer immunotherapy that specifically targets and kills cancer cells, and activates the body’s immune system to attack cancer cells. Multikine is a cancer immunotherapy that incorporates both active and passive immune activity.

CEL-SCI Corp. is based in Vienna, Virginia and develops novel immune-based therapies that utilize the body’s own immune defense system to fight disease. These therapies are effective and non-toxic to the body’s normal cells and organ systems, unlike traditional cancer therapies such as chemotherapy, radiation and surgery, which are most often highly toxic or damaging.

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Zoom Technologies (ZOOM)- Buzz Stock of the Day

Posted on Monday, September 14th, 2009

Shares of communication products maker, Zoom Technologies, Inc.(NASDAQ: ZOOM) were up as much as 140 percent in morning trading Monday from after the company announced second quarter financials for Gold Lion Holdings, a leading Chinese mobile phone manufacturer that Zoom acquired earlier this month.


For the second quarter of 2009, Gold Lion more than tripled its revenues to $53.1 million, compared to the same period last year. Furthermore, second quarter revenues were up 84 percent sequentially. The substantial revenue growth is due in large part to a significant order from one of Gold Lion’s existing customers.

“We are most pleased to report these outstanding quarterly results following the recently announced and shareholder approved transaction with Zoom Technologies,” said Lei Gu, Chairman and Chief Executive Officer of Gold Lion. “We believe these results reflect the burgeoning mobile telecommunications business in China and our ability to drive revenues and profit in this market.”

At a special meeting on September 8, shareholders of Zoom Technologies approved the acquisition of Gold Lion Holdings. The deal is expected to close by the end of September. Under the terms of the acquisition, Zoom shareholders will hold shares in two publicly traded companies, a vertically integrated China-based manufacturer of mobile telecommunication devices called Leimone United, Inc., and its US operating company Zoom Telephonics, which will retain substantially all of Zoom’s assets, liabilities, and current operations prior to the acquisition.

Revenues weren’t the only highlight in the Gold Lion’s second quarter results. The company reported a 147 percent increase in gross profit, and a $200,000 decline in operating expenses compared to the same period last year. Gross profit as a percentage of revenue, however dipped to 5.95 percent, from 10.95 percent in the same period a year ago, primarily because of low gross margins related to a significant order the company received during the quarter.

“These results further demonstrate the value of the transaction we expect to close in September,” said Zoom’s Chairman and CEO, Mr. Frank Manning. “The mobile phone market in China is growing rapidly, and we believe Gold Lion is well-positioned to benefit from this growth.”

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Opexa Therapeutics Inc (OPXA) Buzz Stock of the Day

Posted on Tuesday, September 8th, 2009

Shares of Opexa Therapeutics, Inc.(NASDAQ: OPXA) were up more than 150 percent from Friday’s close in morning trading on Tuesday, after the company announced that more than 83 percent of patients taking its experimental multiple sclerosis drug, Tovaxin, remained relapse-free after one-year.


In addition, the annualized relapse rate among patients who took Tovaxin fell to 20 percent, a 42 percent reduction compared with the placebo. Tovaxin also showed stabilization and improvement of MS-related disabilities in 73 percent of patients, 16.5 percent of which showed sustained improvement of a least one full point on a standard disability scale.

The data was based on a 52-week Phase IIb clinical study that targeted 150 patients with relapsing, remitting multiple sclerosis, typically the initial stage of the disease. Patients in this stage of multiple sclerosis often experience unpredictable relapses, often followed by months or years of dormancy.

“Clinical benefits include not only reduction in relapses, but a surprising reversal of disability in over 16 percent of Tovaxin-treated patients,” said Dawn McGuire, MD, a board certified neurologist and a member of Opexa’s Clinical Advisory Board.

Opexa said it plans to recruit similar patients for another Phase IIb study of Tovaxin, which is a vaccine tailored to individual patients. The drug helps limit attacks by immune system cells called T-cells on myelin, the protein sheath that protects nerves.

Opexa’s news today carried the Stem Cell Stock Index 9.3 percent higher today. The Index, which is compilation of companies using stem cells to develop treatments, is currently ahead of the S&P 500 by 2.7% over the last month.

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The Medicines Co. (MDCO)– Buzz Stock of the Day

Posted on Wednesday, September 2nd, 2009

Shares of The Medicines Co.(NASDAQ: MDCO) was up as much 35 percent on Wednesday morning after the company announced the issuance of a new patent for a safer version of Angiomax, the Company’s anti-clotting drug for patients undergoing coronary angioplasty.

The newly issued patent, No. 7,582,727 (‘727 patent) updates the current patent covering Angiomax, after the company preformed further clinical studies to improve the drug. The ‘727 refers to an improved and safer version of Angiomax.

The new patent has been presented to the U.S. Food and Drug Administration (FDA) for immediate listing in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” generally referred to as the Orange Book. The drug’s current U.S. patent No. 5,196,404 (‘404 patent), expires on March 23, 2010 and specifically relates to the composition of the chemical bivalirudin. Furthermore, The Medicines Company has been granted pediatric exclusivity through September 23, 2010.

In clinical trials, Angiomax showed absolute reduction of 1.7 percent in cardiac mortality and improved overall survival in patients who had suffered the most severe heart attack and received angioplasty. The study, which is called the Horizons-AMI, showed that Angiomax reduced cardiac-related death by 43 percent, improved overall survival by 27 percent and reduced major bleeding complications by 39 percent, compared to the standard of care.

“These results underscore our goal: to bring to doctors critical care medicines that change clinical practice for the better,” said the Company’s President and Chief Operating Officer, John Kelley.

The data also supports results from previous studies that showed an association between reduced major bleeding in angioplasty patients and greater long-term survival.

“The bottom line is that in this population of heart attack patients undergoing PCI, Angiomax saves lives, and the degree of that benefit is striking,” said Kelley.

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Icagen (ICGN)– Buzz Stock of the Day

Posted on Tuesday, September 1st, 2009

Shares of biopharmaceutical company Icagen, Inc.(NASDAQ: ICGN) were up as much as 65 percent from Monday’s close in morning trading on Tuesday, after the company announced favorable results from a late-stage clinical trial of Senicapoc, a potential new treatment for asthma.


“We are pleased with the results of this study, and believe that they justify further evaluation of Senicapoc as a novel approach to the treatment of asthma,” said Seth Hetherington, M.D., Senior Vice President of Clinical and Regulatory Affairs for Icagen.

A total of 34 patients with asthmatic responses to inhaled allergen were enrolled at two clinical research centers in the United Kingdom and 31 of them were evaluable for the study goals.

In the study, patients who received Senicapoc demonstrated an improvement in all measures of late asthmatic response (LAR), while those who received only dummy drugs had no improvements, the company said in a statement.

A secondary goal of the study was to gauge the fraction of exhaled nitric oxide, a measure of airway inflammation that is generally at an elevated level in asthmatic patients. The study found that senicapoc reduced exhaled nitric acid by 24 percent compared to study participants who received the placebo.

“We believe that the combination of the reduction in LAR among the Senicapoc-treated patients, along with the improvement in the fraction of exhaled nitric oxide, is consistent with the potential for an anti-inflammatory effect of Senicapoc, a selective blocker of the KCa3.1 channel,” said Dr. Hetherington.

The North Carolina-based Icogen is currently evaluating strategic options concerning the future of the company, including a possible partnership or the sale of the company.
“We have received interest from several companies to partner us in this program and we will certainly pursue discussions as appropriate,” Chief Financial Officer Richard Katz said in a statement.

Icagen is also developing four proof-of-concept studies in the areas of asthma, epilepsy and pain, but do not plan to pursue the programs any further than the concept phase without additional capital that could come in a variety of forms.

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