CVM: Cel-Sci Corp might be starting to make some noise again. The company made it known publically this week that it had terminated a pre-existing funding agreement, leaving some to wonder if something more significant is going on behind the scenes.
Cel-Sci followed up news of the termination with an update on its ongoing world-wide trial for Multikine, a cancer immunotherapy treatment being investigated in Phase III trials for its potential as a first line treatment for head and neck cancer. What sets Multikine a step above other cancer immunotherapy treatments, should it demonstrate positive Phase III results and make it to market, is that it is an "off the shelf" vaccine, unlike other treatments - such as Dendreon's (DNDN) Provenge - that need patient cells in order to 'personalize' the treatment.
In the list of highlights announced by the company following the termination news, it was noted that patients have been enrolled in the Phase III trial on all three continents where the trial is taking place - North America, Europe and Asia. It was also noted that 36 clinical centers have met all the necessary conditions to begin enrolling patients.
"We are pleased that enrollment in this clinical study has been accelerating,” noted Cel-Sci CEO Geert Kersten in Wednesday's press release. It was also announced that Cel-Sci is already looking to expand the amount of clinical centers available in the trial to increase the capacity for enrollment.
One missing detail, however, is the number of patients enrolled. The trial kicked off during the last days of 2010, and given that over 800 patients are planned to be treated with Multikine during the course of the trial, investors are looking for the opportunity to guage the current pace of enrollment.
An earlier update by Cel-Sci was also vague when talking specific numbers of enrollment, but the consistent statements are that the pace is "accelerating."
The termination of the funding agreement could turn out to be nothing, but some will speculate that Mr. Kersten and the Cel-Sci team might have secured another source of funding, possibly a new partner.
Interest in the CVM stock increased following the news updates, judging by a volume spurt, so it might be worth keeping an eye on this one during the closeout of 2011 and into the new year in 2012.
Should it make to market, Multikine has blockbuster potential.
ONTY: Another cancer immunotherapy stock that is starting to make some noise again is Oncothyreon (ONTY). Shares of ONTY flew to over eight bucks early this week as the company's trial for Stimuvax in non-small cell lung cancer winds down and results are compiled for a 2012 release. Anticipation of the Phase III conclusion announcement has had ONTY shares on the move all year, reaching highs of over ten bucks at one point when MSNBC's Jim Cramer jumped on board.
Stimuvax is partnered with Europe's Merck KGaA, with whom Oncothyreon will share revene, should Stimuvax make it to market.
The company also announced this week that Robert Kirkman, M.D., President and Chief Executive Officer, will be presenting at the Oppenheimer 22nd Annual Healthcare Conference in New York on Wednesday, December 14.
Dendreon (DNDN) shares originally started to fly after its Phase III trial was completed and an FDA advisory committee voted in favor of the treatment being safe and effective, and investors may be eyeballing ONTY for a similar price rise as the Phase III winds down.
The Oncothyreon story will be one to watch, not just for the coming weeks, but well into 2012.
PBTH: Israel's Prolor Biotech (PBHT) has been garnering a little bit more attention these days, with its novel Carboxyl Terminal Peptide (CTP) technology that, when attached to already-existing therapeutic proteins, significantly extends their life span reducing the amount of injections needed for patients during the course of treatment.
The company's flagship product candidate, for instance, hGH-CTP, would effectively reduce the number of weekly injections from seven to one, should it make to market in the treatment of hormone deficiency. Studies are still ongoing for the indication of hormone deficiency in both children and adults, and a Phase III trial is expected to commence in 2012 for the treatment of adults.
Prolost also has a strong patent portfolio that strengthens the company's potential to bring this technology to market and is actively seeking partners that would allow the company to license its technology and provide revenue streams outside of dilutive financing.
Like Oncothyreon (ONTY), Prolost is planning on presenting at the Oppenheimer 22nd Annual Healthcare Conference in New York on Wednesday, December 14, so expect interest in this company to potentially increase as word of its novel technology spreads.
AMPE: Ampio Pharmaceuticals (AMPE) has already enjoyed a solid string of encouraging pipeline news updates during the course of 2011, and that string could stretch into 2012 with a few near-term catalysts still coming into play.
Lead product Ampion continues to demonstrate trial results that have the product primed to make a play for major market share in the anti-inflammatory sector, and the company's drug for premature ejaculation, Zertane, is being primed for near-term commercialization.
Earlier this week Ampio announced a key acquisition of drug delivery technology that strengthens its bid to maximize the market potential of Zertane as a treatment for both premature ejaculation and erectile dysfunction. The Acquisition relates to a "patented orally disintegrating tablet (ODT) drug delivery technology that can be used worldwide to elevate the market acceptance of Ampio's Zertane."
Another announcement this week from the company related to the strengthening of its patent portfolio for Ampion. The patent news came from Europe where Ampio's patent request for the broad use of the active ingredient in Ampion as an anti-inflammatory was granted.
Ampio continues to be a growth story to watch with multiple ongoing trials and a pipeline with the potential to infiltrate multiple major markets. The news this week only strengthens the company's potential for success.
NBY: Volume has been increasing for NovaBay (NBY), a company that may have the answer to the ongoing medical dilemma of antibiotic resistance. Positive trial news to close out November reinforces the potential of the company, which is ready to complete and/or commence multiple mid to late stage trials. Considering NovaBay's market cap, there is reason to believe that the share price could grow significantly if the results from previous studies continue and the company's products are set up to move onto the market as a potential replacement for standard antibiotic care.
Keep an eye out for a few milestone events are set to unfold in the coming months that could put the company and its technology in the spotlight. Trials are set to commence, continue and conclude in the field of urology, dermatology and opthalmology, and a pending commercial launch of its first FDA-cleared product, NeutroPhase in the treatment of chronic wound care, is also expected for 2012. A successful launch of NeutroPhase, for which NovaBay has received two FDA clearances in the field of hospital wound care, would put the company on the scene as a commercial stage company while the rest of the pipeline develops.
If NovaBay can successfully commercialize NeutroPhase, which would be entering a large market in chronic wound care, then the threat of dilutive financing to fund the future is reduced.
A story to watch as interest picks up.
GLTC: GelTech Solutions (OTCBB: GLTC) is another one with commercialization plans that can thrust the company and its eco-friendly products into the global spotlight. This company's water-enhancing firefighting product, FireIce, is being prepared for a launch into the global firefighting market at a time when local and national governments around the globe are looking to conserve both natural and monetary resources.
FireIce has already received the highest certifications from the US Forest Service, freeing the product up for global distribution, and was awarded the equivalent status in Australia and New Zealand this week.
FireIce has multiple fire-suppressing and fire-preventing applications, for both domestic and commercials use, and could become a major part of firefighting of the future as distribution picks up.
Shares were on the move this week, and may be even moreso as additional distribution deals are announced.
CCLR: Chanticleer Holdings (OTCBB: CCLR) announced the 'grand opening' of its new corporate website this week, geared towards keeping shareholders informed of the company's expanding 'Hooters' restaurant operations. Chanticleer, which along with significant investor backing, owns rights to the Hooters name and is one of many major US restaurant companies looking to take advantage of expansive international growth.
Chanticleer has already expanded into the South African and Australian markets this year with Hooters locations, and additional expansion is planned for the coming months and years.
Given the legal battle that the company undertook to defend its 'first right of refusal' to acquire the Hooters name from the Brooks estate, it's also worth considering that another company or brand will eventually look to purchase Chanticleer - or the Hooters name itself - marking CCLR as a potential takeover candidate as well.
Disclosure: Long CVM, NBY, CCLR.